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This study aimed to evaluate the safety and acceptability of two fixed-dose 28-day vaginal ring formulations of 17β-estradiol (E2) and progesterone (P4) to treat vasomotor symptoms (VMS) and the genitourinary syndrome of menopause. DARE HRT1-001 was the first-in-woman study of 28-day exposure to two 28-day intravaginal rings (IVRs) designed to release 80 µg/day E2 + 4 mg/day P4 (IVR1) or 160 µg/day E2 + 8 mg/day P4 (IVR2) compared with oral E2 1 mg/day + oral P4 100 mg/day. To assess safety, participants completed a daily diary to record treatment emergent adverse events (TEAEs). To determine acceptability, at the end of treatment IVR users completed a questionnaire assessing tolerability and usability. Enrolled women (n = 34) were randomized to use IVR1 (n = 10), IVR2 (n = 12) or oral (n = 12). Thirty-one participants (IVR1 = 10, IVR2 = 10, oral = 11) completed the study. The TEAE profile of those in the IVR groups were similar to the referent oral regimen. TEAEs related to the study product were more common with IVR2 use. Endometrial biopsies were not performed unless endometrial thickness was >4 mm or for clinically significant postmenopausal bleeding. One IVR1 participant had an endometrial stripe increase from 4 mm at screening to 8 mm at the end of treatment. The biopsy indicated no evidence of plasma cells or endometritis and no evidence of atypia, hyperplasia or malignancy. Two other endometrial biopsies were performed for postmenopausal bleeding with similar findings. There were no clinically meaningful laboratory or vital sign abnormalities or trends identified in observed values or changes from baseline. Pelvic speculum examination identified no clinically significant abnormalities in any participant at any visit. Tolerability and usability data demonstrated that both IVRs were generally highly acceptable. Both IVR1 and IVR2 were safe and well tolerated in healthy postmenopausal women. TEAE profiles were comparable to the referent oral regimen. [ABSTRACT FROM AUTHOR]

In this multicenter, observational, controlled open-label trial, researchers randomized 200 women with vulvovaginal candidiasis (VVC) to: Group 1, 6-days clotrimazole 2% vaginal cream once-daily plus 15-days concomitant acid pH thymol and zinc-containing cleansing wash (SaugellaActi3) twice-daily; Group 2, 6-days clotrimazole treatment alone. In both groups, pruritus and burning VAS scores improved from baseline at Days 6, 10 and 15. On Day 10 and Day 15, the pruritus score was significantly lower in Group 1 versus Group 2 (P <0.005 at both timepoints), suggesting acid pH thymol and zinc-containing cleansing wash ameliorates VVC-associated pruritus as part of a female hygiene regimen. [ABSTRACT FROM AUTHOR]

Postpartum depression (PPD) is detrimental to the mother and the family as a whole. Early initiation of appropriate treatment is important. The aim of this pilot study was to evaluate the efficacy and adverse effects of oestradiol treatment. We performed a pilot double-blind, randomized, placebo-controlled study. Major depression was diagnosed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), and the severity of depression was evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The duration of treatment with sublingual oestradiol hemihydrate (1–3 mg/day) was 12 weeks. The treatment group consisted of 16 mothers and the placebo group of 14 mothers. Thirteen mothers in the treatment group and ten in the placebo group recovered from depression during the treatment period as measured with the EPDS (<10). There was no evidence to suggest that oestradiol was more effective than placebo. More mothers in the treatment group than in the placebo group (eight vs. one) received gestagen treatment for irregular bleeding. Oestradiol did not disturb breastfeeding. The mean number of other adverse effects per mother was lower in the treatment group, and these were mostly somatic symptoms. Our findings warrant further studies on oestrogen therapy for PPD with and without antidepressant and gestagen therapy, and on adverse effects (including effects on vaginal bleeding and breastfeeding). [ABSTRACT FROM AUTHOR]

Aim: We investigated the arcuate artery blood flow in the region of the abnormally localized placenta in women who had undergone insertion of an obstetric pessary and were receiving micronized progesterone.Materials and Methods: The study included 120 pregnant women with high perinatal risks and abnormal placental localization. The patients were randomized to receive the Arabin's pessary and vaginal micronized progesterone (Group A, n = 60) or vaginal micronized progesterone only (Group B, n = 60). Randomization was carried based on the order of hospital admission: odd patient numbers were allocated to Group A and even numbers to Group B. Patients underwent a series of ultrasound scans to evaluate the placental migration and presence of abnormal placental attachment. Depending on the results of the scan, study participants were divided into the following groups: (1) patients without placental migration: A1 (n = 23) and B1 (n = 42); and (2) patients with placental migration: A2 (n = 37) and B2 (n = 18). Women in subgroups A1 and B1 were further divided into the subgroups based on the presence of abnormal placental attachment: A1x (n = 5) and B1x (n = 12) with abnormal placental attachment; and A1O (n = 18) and B1O (n = 30) without the abnormal placental attachment.Conclusion: In patients with abnormal placental attachment, the resistance of blood flow in the arcuate arteries was significantly higher than in those with normal placental attachment. A significant increase in the blood flow resistance occurred between 24 and 28 weeks of gestation. The combined use of the obstetric pessary and vaginal micronized progesterone in women with abnormal placental localization helped maintain the resistivity index at low levels and reduce the rate of abnormal placental attachment by 1.3-fold (OR 0.694 (95% CI: 0.21-2.29)). [ABSTRACT FROM AUTHOR]

Objective: Vaginal progesterone and cervical pessary are both shown to be effective in preventing preterm. We conducted a meta-analysis to evaluate whether the combination of these two interventions has any additional benefit in preventing preterm birth and improving perinatal outcomes in asymptomatic women with a singleton gestation who had a midtrimester sonographic short cervix compared with vaginal progesterone alone.Methods: Five databases were searched from their inception to 21 February 2019. We estimated relative risk (RR) and 95% confidence intervals (CIs) for dichotomous outcomes. The primary outcome was preterm birth <34 weeks, and second outcomes included low birth weight (LBW) delivery, perinatal death, and neonatal intensive care unit (NICU) admission.Results: Three RCTs with a total of 820 participants were identified. Cervical pessary had no significant prevention effect of preterm birth when combined with vaginal progesterone compared to the control group with vaginal progesterone alone (RR = 0.91; 95% CI, 0.47-1.77). No significant difference has been revealed between groups in LBW delivery (RR = 1.13; 95% CI, 0.86-1.48), perinatal death (RR = 1.27; 95% CI, 0.58-2.78) and NICU admission (RR = 1.24; 95% CI, 0.84-1.85).Conclusions: Comparing with vaginal progesterone alone, cervical pessary plus vaginal progesterone did not reduce the rates of preterm birth at <34 weeks of gestation. There was no difference in LBW delivery, perinatal death, and NICU admission. We need more evidence to balance the benefit and side effects on the combination of vaginal progesterone and cervical pessary for preventing preterm birth. [ABSTRACT FROM AUTHOR]

Purpose: Preterm birth is the leading cause of perinatal morbidity and mortality. Vaginal progesterone cervical cerclage and Arabin cervical pessary are considered as preventive treatments in women at risk for preterm birth. However, there is less evidence as to which of these interventions is the preferred management. The current study aims was to compare the outcome of pregnancy in women with a short cervical length managed with 4 different treatment protocols: therapy with vaginal progesterone, cervical cerclage and an Arabin cervical pessary (group A), Arabin cervical pessary and vaginal progesterone (group B), cervical cerclage and vaginal progesterone (group C), or vaginal progesterone alone (group D).Methods: A retrospective cohort study of singleton pregnancies managed in three tertiary medical centers between September 2011 and December 2017.Results: In the study period, 286 pregnant women underwent vaginal ultrasonography between 15 and 29 weeks gestation. They all had a short cervical length (≤25 mm). Of these, 18 (6.3%), 120 (41.9%), 38 (13.3%) and 110 (38.5%) patients received treatment classifying them into groups A, B, C, and D, respectively. A significantly higher rate of patients in group A had either a history of cervical incompetence (44.4 versus 9.2 versus 7.9 and 0.9%, respectively, p = .0001) or a cervical procedure (61.1 versus 37.5 versus 28.9 and 27.3%, respectively, p = .027) compared to patients in group B, C, and D. Despite having a shorter cervical length at recruitment in group A (median (range); 14.5 (0-25) versus 15 (0-25) versus 15.5 (0-25) and 19 (2-25) mm, respectively, p = .002) the rate of spontaneous preterm delivery <37-week gestation was similar across groups (44.4 versus 32.5 versus 36.8 versus 32.7%, respectively, p = .665).Conclusion: A combined rescue therapy involving vaginal progesterone, cervical cerclage, and Arabin cervical pessary emerges as a promising management strategy in pregnant women who have a short cervical length and a high background risk for preterm delivery. This combination may prolong their pregnancy and safely bring them near term. Additional studies are needed to confirm these preliminary findings. [ABSTRACT FROM AUTHOR]

Aim: This study was performed to evaluate the effects of vaginal versus intramuscular progesterone supplementations on the mood, quality of life, and metabolic changes in pregnant women with the history of previous preterm birth.Methods: This study was conducted as a prospective, randomized, open label, clinical trial evaluated 100 pregnant women who referred for prenatal visit, with 16-17 weeks of gestation from September 2014 through October 2015. The mothers were then randomly allocated into two groups: the vaginal progesterone group to receive 400 mg cyclogest vaginal suppositories (Actavis, UK limited, England) once daily, and the intramuscular progesterone group to receive weekly intramuscular injections of 250 mg of 17-hydroxyprogesterone caproate (17-HPC) (Bayer Schering Pharma, Germany), starting from the 16th to the 35th weeks of pregnancy. Demographics, medical and obstetrical history, sleeping disturbances, alteration in sexual desire, nausea/vomiting, serum levels of fasting blood sugar (FBS), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were evaluated, first and 8 weeks later.Results: About 11 (11.2%) screened positive for psychosocial disorders; 25 (25.5%) had sleep disturbance, 11 (11.2%) had alteration in sexual desire, and 29 (29.6%) had nausea/vomiting upon enrollment. After 2 months of receiving daily vaginal progesterone, there was a significant increase in the GHQ-28 score (p < .001), and rates of positive screening for psychosocial disorders (p = .001) in this group. No statistically significant differences were observed in the HDL levels (p = .06), LDL levels (p = .15), rates of impaired FBS (p = .08), nausea/vomiting (p = .2), sexual desire alteration (p = .56), and sleep disturbance (p = 1) in the participants who were randomized to this group.Conclusion: Our results indicated that psychosocial disorders increased significantly at 24th week gestational age after 2 months of progesterone consumption in both groups which could show psychological impact of progesterone regardless of the route of consumption. This calls for higher psychological attention in these women. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the pharmacokinetics and pharmacodynamics of oestriol (E3) and trimegestone (TMG) in healthy women after application of three different vaginal rings over 21 days. The vaginal rings had a nominal delivery rate of 0.413/0.050 mg/day (Test 1), 0.311/0.090 mg/day (Test 2) and 0.209/0.137 mg/day (Test 3) E3/TMG.Methods: Thirty-five healthy women were randomised to receive a single application of Test 1, 2 or 3 (Clinical Trial NCT03343912). The E3 and TMG plasma concentration was determined by LC-MS/MS. Oestradiol (E2) and progesterone (PG) serum concentrations, and bleeding patern were determined as pharmacodynamic parameters. Safety was assessed by evaluation of adverse events and local tolerability.Results: The total and maximum exposure of E3 and TMG increased in a proportional ratio to dose. However, not in a magnitude which was expected from the dose differences for E3. During Test 2 and 3 treatment all E2 and PG values remained on a well suppressed level until end of treatment. E2 and PG serum levels increased distinctly earlier after ring removal with Test 1 compared to Test 2 and 3. Test 3 achieved 95.24% of "no bleeding" days under treatment followed by Test 1 (91.67%), and Test 2 (86.15%).Conclusions: The Test 3 formulation presented the best dose combination of E3/TMG for contraception. Moreover, all vaginal rings were well tolerated. [ABSTRACT FROM AUTHOR]

We aimed to assess whether the second-trimester maternal serum markers could be used for the prediction of labour induction success. This prospective study enrolled women planned labour induction at term. Women were assigned to one of two groups: vaginal prostaglandin or balloon dilatation. All patients were evaluated for Bishop score, maternal serum oestriol, human chorionic gonadotropin and progesterone at the time of second-aneuploidy screening. The total successful rate for induction of labour was 63.9% in both groups. Maternal serum oestriol multiple of median (MoM) values were significantly lower among the caesarean section group compared to the vaginal delivery group (p < .001). A MoM value of 0.74 for oestriol was associated with a sensitivity of 75.9%, specificity of 41.0%, a positive predictive value of 76.6% and a negative predictive value of 58.0% for a successful induction of labour. Oestriol had a good performance in the prediction of successful induction of labour at term.IMPACT STATEMENTWhat is already known on this subject? Induction of labour is a common procedure undertaken whenever the benefits of prompt delivery outweigh the risks of expectant management. Previous studies have reported that a decreased progesterone/oestradiol ratio and increased maternal plasma oestriol levels are associated with successful labour. What the results of this study add? The results of this study showed that second-trimester oestriol multiple of median (MoM) value provide a significant contribution to the efforts of the prediction of successful induction of labour in term pregnancy, having a sensitivity of 69.8%, specificity of 92.4%, positive predictive value of 83.3% and negative predictive value of 82.5%.What the implications are of these findings for clinical practice and/or further research? This finding can be used as an additional method for prediction of labour induction as well as multiparity and Bishop score. This adds new valuable data to the literature which could be used for systematic reviews and for implementing guidelines and protocols on labour induction. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to examine the efficacy of a combined management with cervical pessary and vaginal progesterone of women with a singleton pregnancy and a short cervix in both low and high risk-cases based on their previous obstetrical history and maternal factors.Study Design: This was a prospective cohort study of women with a singleton pregnancy and a sonographically detected mid-trimester cervical length ≤ 25 mm. The high-risk group consisted of women with a history of a previous spontaneous preterm birth (PB), or a second-trimester miscarriage, or a loop electrosurgical excision procedure of the cervix (LEEP) while the low-risk group of women without such a history. All women were managed with cervical pessary and daily vaginal administration of 200 mg of progesterone. The primary outcome measure was spontaneous delivery before 34 weeks (238 days) of gestation.Results: One hundred ninety-six cases with a CL ≤ 25 mm were detected during the study period. Fifty-two women declined to participate in the study. The remaining 144 women were divided into two groups based on the presence (n = 44) or absence (n = 100) of specific risk factors for PB. The rate of PTB < 34 weeks was similar in both low and high-risk pregnancies while a significantly higher rate of sPTB < 37 weeks was found in women with high-risk pregnancies (p = .005).Conclusion: The combined treatment of cervical pessary and vaginal progesterone has a similar influence on preterm delivery rate < 34 weeks, in both low and high-risk women, with a mid-trimester short cervix. [ABSTRACT FROM AUTHOR]

Background: Men play a key role in influencing uptake of women's health products, such as female condoms and vaginal microbicides used for family planning and HIV prevention. Method: We explored men's perceptions of the dapivirine vaginal ring (DVR), a vaginal microbicide, in Kalungu District, rural south-western Uganda. In June/July 2018, we conducted in-depth interviews with 10 partners of women participating in the DREAM study, a phase 3B open-label extension trial of the DVR. Data were analysed thematically, drawing on the socio-ecological model theoretical framework. Results: Influencing factors such as individual and interpersonal characteristics, perception of HIV risk, lack of knowledge about the DVR, misconceptions, and product characteristics acting at different levels (individual, societal and organisational) affected men's knowledge, attitudes and perceptions towards the DVR, which in turn impacted on their willingness to allow their partners to use it. Above all, men wanted to be involved in the decision- making process about the use of the DVR. All the men were happy that there was a new HIV prevention option in the pipeline and were not concerned about the degree of effectiveness, saying it was better than nothing. Conclusion: The use of the DVR in an environment where men expect to make decisions about sex on behalf of women may affect its usage and success. Given this context, women may not always be able to independently choose to use it. If the DVR is approved and rolled out, increased sensitisation of men about it will be critical to ensure its uptake. [ABSTRACT FROM AUTHOR]

Purpose: To compare between continuous and interrupted use of vaginal probiotic after vaginal clindamycin cream for treatment and prevention of recurrence of bacterial vaginosis.Methods: A double-blinded randomized controlled clinical trial, 273 women were randomly allocated to use clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed after 1 week by continuous probiotics vaginal capsule once daily for 6 weeks (n = 129) or clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed by one probiotic vaginal capsule twice a week for 6 weeks (n = 144). The initial evaluation was at 1 week after cessation of probiotics treatment to estimate the cure rates, the follow-up visits were at 1, 3, 6, and 9 months from the initial visit. The primary outcome of this study was cure rate; the secondary outcomes were the frequency of recurrence, the presence of vaginal discharge, pH > 4.5, positive whiff test and detection of clue cells.Results: At the initial visit there was no significant difference in cure rate between continuous probiotics group and interrupted probiotics group (87.4 versus 82.5%; p = .81). There was no significant difference between the two groups in the recurrence rate at one, three, six and 9 months follow up visits (p = .16, p = .42, p = .59, p = .66). There was no significant difference between both groups regarding vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells at one, three, six and 9 months follow up visits. Except at 9-month visits, the differences in vaginal discharge reduction and positive whiff test were statically significant.Conclusions: After initial treatment of bacterial vaginosis with vaginal clindamycin cream, the continuous use of vaginal probiotics is equally effective to short repetitive courses in terms of cure rates and prevention of relapse. [ABSTRACT FROM AUTHOR]

Objective: To determine if vaginal misoprostol is more effective than oral misoprostol for cervical ripening in obese women.Study design: A retrospective cohort study of obese women undergoing induction of labor from Jan 2013 to Dec 2016 with singleton, viable pregnancies beyond 37 completed weeks of gestational age. Women with an initial Bishop score of 7 or less, with a cervical dilatation of less than 2 cm, who received either vaginal or oral misoprostol as a cervical ripening agent, were included. Primary outcome was interval from the start of induction to the attainment of 3 cm cervical dilatation. Secondary outcomes included the interval from the start of induction to delivery and the rate of cesarean delivery (CD).Result: Of women who met the inclusion criteria, 966 (75.5%) women received oral misoprostol and 314 (24.5%) received vaginal misoprostol. The mean time-interval from the start of induction to attainment of 3-cm dilatation was shorter in the vaginal group (10.5 ± 10.4 h) compared to the oral group (17.2 ± 11.5 h), (p < .0001). Significantly shorter times to delivery were also noted in the vaginal group (17.4 h for vaginal vs. 24.8 h for oral, p < .0001). In the subgroup analysis of nulliparous women, shorter time intervals from the start of induction to attainment of 3-cm dilatation, as well as to delivery, were noted in the vaginal misoprostol group (p < .0001 for both). Multiple linear regression model confirmed route of misoprostol administration as an independent variable in predicting the outcomes (time from start of induction to 3 cm as well as to delivery). Significant findings amongst neonatal outcomes included lower umbilical artery pH and higher rates of neonatal jaundice in the oral misoprostol group.Conclusion: In a population of obese women undergoing induction of labor, vaginal administration of misoprostol was associated shorter time intervals from the start of induction to the attainment of 3 cm of dilatation, as well as to delivery, without increasing the rate of cesarean deliveries or the incidence of adverse maternal and neonatal outcomes. [ABSTRACT FROM AUTHOR]

Objective: To compare the effect of misoprostol combined with a cervical single or double-balloon catheter versus misoprostol alone for labor induction of singleton pregnancies with an unfavorable cervix.Methods: Systematic review and meta-analysis of randomized controlled trials (RCTs) regarding the comparison of two schemes for labor induction of singleton cephalic pregnancies with a Bishop score ≤7 and no contraindication for vaginal delivery. Six research databases were searched for articles published in all languages up to 10 May 2018 comparing misoprostol (oral or vaginal) in combination with a cervical placed single or double balloon catheter versus misoprostol treatment alone. Random effects models and inverse variance were used for meta-analyses. Summary measures were mean differences (MDs) and risk ratios (RRs) with 95% confidence interval (CI). Risk of bias was evaluated with the Cochrane tool and publication bias was assessed with Begg's and Egger's tests.Results: Fifteen RCTs reported predefined outcomes. Pooled analyses showed that the combined treatment (misoprostol + catheter) was associated with a shorter induction to delivery time interval (MD = -1.99 hours; 95% CI: -3.42, -0.56); in addition to fewer uterine hyperstimulations (RR = 0.39; 95% CI: 0.23, 0.67) and Neonatal Intensive Care Unit (NICU) admissions (RR = 0.75; 95% CI: 0.58, 0.97) as compared to misoprostol alone. There were no significant differences in RRs for tachysystole, chorioamnionitis, cesarean delivery rate, birthweight, and Apgar score at 5 minutes.Conclusion: The combined use of misoprostol and a cervical balloon catheter reduces the intervention to delivery time interval and number of NICU admissions in women induced with an unfavorable cervix. [ABSTRACT FROM AUTHOR]

Purpose: To compare the rate of preterm delivery in pregnant women with a short cervical length managed with Arabin cervical pessary and vaginal progesterone versus vaginal progesterone alone.Methods: This was a retrospective cohort study of singletons pregnancies managed in two tertiary medical centers between September 2011 and May 2017. One center utilized the combined treatment of Arabin cervical pessary and vaginal progesterone (study group) and the second utilized vaginal progesterone approach (control group).Results: During the study period, a total of 202 pregnant women who underwent vaginal ultrasonography between 15 and 29 weeks gestation. They all had short cervical length (≤25 mm). Among them, 94 (46.5%) and 108 (53.5%) patients were in the study and control group, respectively. A significantly higher rate of patients in the study group had either a history of cervical incompetence (9.6 vs. 0.9%, respectively, p = 0.006) or cervical surgery (7.9 vs. 0%, respectively, p = .003). Despite having shorter cervical length at recruitment (14.3 ± 5.9 vs. 16.9 ± 5.7, respectively, p = .002) the rate of spontaneous delivery < 34-week gestation was lower in the study group (7.4 vs. 17.6%, respectively, p = .036) and they delivered 1-week later compared to the control group (37.2 ± 2.1 vs. 36.2 ± 3.7, respectively, p = 0.02).Conclusion: We found that for pregnant women with singletons and who had a short cervical length, the combined treatment of Arabin cervical pessary and vaginal progesterone had lower rate of preterm delivery < 34 weeks of gestation and prolonged gestation compared to those women who were treated with vaginal progesterone alone. Our preliminary findings warrant randomized control studies in order to further illuminate our results. [ABSTRACT FROM AUTHOR]

Transvaginal laser therapies are being increasingly used for a variety of indications, particularly genitourinary syndrome of the menopause and stress urinary incontinence. This article reviews the current data pertaining to the place of these devices in current clinical practice. Whilst there has been a rapid increase in the number of publications over the last few years, many of the studies are of small numbers, short duration, and poor quality and are device-sponsored. The evidence suggests that vaginal laser therapy with either the erbium-doped yttrium aluminum garnet laser (FotonaSmooth®) or the CO2 laser (MonaLisa Touch®) is an effective intervention for the relief of symptoms of vulvovaginal atrophy in symptomatic women. The benefits of three laser treatments appear to last for at least 12 months and the procedure is generally well tolerated, with transient minor discomfort being the most common adverse event. Whilst the vaginal laser certainly has the potential to be an alternative treatment to vaginal estrogens for those groups of women, such as breast cancer patients, who cannot take them, there are still many unanswered questions about the role of vaginal laser therapy in clinical practice, particularly in relation to standard conservative management. The place of vaginal laser therapy in other conditions such as stress urinary incontinence is less clear. The outcomes from several ongoing randomized trials should help to answer some of these questions. In the meantime, the use of vaginal laser devices should be confined to clinical trials. [ABSTRACT FROM AUTHOR]

Pre-Exposure Prophylaxis (PrEP) trials often implement counseling to support product adherence. Counseling fidelity can vary significantly across providers and time. Fidelity monitoring can ensure that counseling is delivered as designed. We describe the process, feasibility, and outcomes of monitoring Options counseling fidelity in an open-label study of the dapivirine vaginal ring MTN-025/HOPE. After initial training, 63 counselors from 14 sites in Sub-Sahara Africa audio-recorded counseling sessions with study participants. Sessions were rated by a New York-based team that included bilingual emigres from the study countries. Completed session rating forms were sent to counselors to provide feedback and counseling difficulties were discussed during monthly calls. Of 1456 study participants, 85.7% consented to at least one session, and 20% to all sessions, being audio-recorded. Among 9926 study visits in which Options was expected to occur, 5366 (54.1%) Options sessions were audio-recorded, of which 1238 (23.1%) were reviewed; 1039 (83.9%) were rated as "good" or "fair." Eleven counselors who failed to consistently deliver the intervention were reassigned to back-up status. This study demonstrates the feasibility and benefits of monitoring counseling fidelity using audio-recordings in a multi-site, multi-language, multi-country PrEP trial. Given the investment necessary to conduct such trials, providing counseling oversight is highly warranted. [ABSTRACT FROM AUTHOR]

Prolonged pregnancies are associated with foetal and neonatal complications. This study was performed to evaluate the efficacy of intravaginal isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. 122 pregnant women were recruited. Women were assigned to 25 µg sublingual misoprostol plus 40 mg isosorbide mononitrate or placebo. Statistical analysis was done using SPSS software (version 23) and T-test, Mann-Whitney and Chi-square test. p ≤ .05 was considered significant. The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group (p = .02). The mean time from beginning of cervical ripening to the beginning of active phase of Labour was comparable between two groups (p = .274). The misoprostol plus IMN group had significantly shorter interval from the beginning of cervical ripening to the time of delivery. Isosorbide mononitrate in combination with misoprostol has a promising effect on cervical ripening and progress in labour.IMPACT STATEMENTWhat is already known on this subject? Prolonged pregnancy is associated with foetal, neonatal, and maternal complications. Because of these complications, many obstetricians tend toward the induction of prolonged pregnancies to reduce perinatal morbidity and mortality. Isosorbide mononitrate is a nitric oxide donor agent which is used vaginally for cervical ripening in term pregnancies resulting in various outcomes.What do the results of this study add? Isosorbide mononitrate in combination with misoprostol had a greater effect on cervical ripening and progress in labour than misoprostol alone in prolonged pregnancies.What are the implications of these findings for clinical practice and/or further research? According to results of the current study; using isosorbide mononitrate in combination with misoprostol could enhance successful vaginal delivery in prolonged pregnancy. Evaluation of maternal satisfaction by using this protocol is recommended in future studies. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess Gonadotropin Releasing Hormone agonist (GnRHa) trigger results of fresh in vitro fertilisation (IVF), Intracytoplasmic Sperm Injection (ICSI) cycles in high-responder patients. Thirty-six high-responder patients, undergoing GnRH antagonist protocol combined with GnRHa trigger for final oocyte maturation, were included. All cycles were autologous fresh transfer cycles. Fifteen of 36 patients had previous IVF/ICSI cycles triggered with human chorionic gonadotropin (hCG) and both cycles of these patients were compared. The mean fertilisation rate, blastocyst development and clinical pregnancy rates were 67%, 44.4% and 44.4%, respectively. The hCG and GnRHa trigger cycles of the same patients were compared as two groups (n: 15). 2PN oocyte counts were significantly higher in agonist trigger cycles (p .048). There were no differences in terms of M2 oocyte count and fertilisation rate. The blastocyst formation and clinical pregnancy rates for hCG and GnRHa trigger cycles were 33.3-66.7% and 13.3-46.7%, respectively. These results were found to be 2-fold and 3.5-fold higher, but not statistically significant. GnRHa trigger in combination with LPS is a good option for final oocyte maturation due to its good pregnancy outcomes and virtually eliminating OHSS risks.IMPACT STATEMENTWhat is already known on this subject? Gonadotrophin releasing hormone agonist (GnRHa) trigger is effective in the induction of oocyte maturation and prevention of Ovarian Hyperstimulation Syndrome (OHSS) on IVF cycles using antagonist protocol.What do the results of this study add? The main strength of this study is the comparison of different triggers in different cycles of the same patients. GnRHa trigger in combination with Luteal Phase Support (LPS) is a good option for final oocyte maturation due to its good pregnancy outcomes and virtually eliminating OHSS risks.What are the implications of these findings for clinical practice and/or further research? We suppose that GnRHa trigger combined with modified LPS is clinically more successful than Human Chorionic Gonadotropin (hCG) in regard to OHSS prevention and reproductive outcomes on fresh IVF/ICSI cycles. More extensive studies are needed to draw firm conclusions. [ABSTRACT FROM AUTHOR]

Men desire to be involved in their partner's decision-making about vaginal microbicide use. This coincides with women's desire to inform male partners about their microbicide use. Educating men about microbicides may enhance acceptability and generate critical support for the female participants of microbicide trials. In this multiphase mixed-methods study, we adapted an educational intervention on vaginal microbicides and tested it among men (n = 45) to determine its effect on men's knowledge regarding HIV/STI, vaginal microbicides and microbicide trials. We also conducted focus group discussions (FGDs) with the female partners (K = 3, n = 43) of the study participants and community representatives (K = 2, n = 24) to obtain their views on male partner microbicide education. We analysed FGD data for key themes using content analysis. HIV and vaginal microbicide knowledge scores increased significantly among men after the educational intervention. Both women and men highly supported male partner microbicide education, in the context of existing gender relations, to increase men's understanding about microbicides, promote adherence and help women gain their partners' trust. Complex gender dynamics should be considered when designing male partner educational interventions to improve acceptability and the use of microbicides and other female-initiated HIV prevention methods. [ABSTRACT FROM AUTHOR]

Objective: To evaluate opioid consumption among parturients with varying degrees of perineal lacerations.Methods: This was a retrospective analysis of women who delivered vaginally at our institution from 1 January 2014 to 12 April 2015. We collected information regarding the degree of perineal lacerations (no lacerations, first-/second-degree, third-/fourth-degree), analgesic consumption, and postpartum pain scores. The primary outcome was opioid use from 0-48 h postpartum. Univariate and multivariable regression analyses were performed to test for the association of laceration severity with opioid use.Results: We included 5598 women in the analysis; 1948 had no lacerations, 3434 had first-/second-degree lacerations, and 216 had third-/fourth-degree lacerations. In univariate analysis, parturients with third-/fourth-degree lacerations had significantly higher use of opioids within 48 h postpartum (53.2%) compared to women with no lacerations (30.03%) or first-/second-degree lacerations (28.6%) (p < .001). In the multivariable analysis, women with third-/fourth-degree lacerations had higher odds of opioid use than those without laceration [OR (95% CI) = 2.61 (1.75-3.85), p < .001]. In pairwise comparisons, those with third-/fourth-degree lacerations had higher odds of opioid use than those without lacerations [OR (95% CI) = 3.55 (2.20-5.74)], and those with first-/second-degree lacerations [OR (95% CI) = 2.15 (1.49-3.10)] (p < .001). Oxycodone equivalent consumption was significantly different among groups with a median (IQR) of 5.00 mg (0.00-27.50), 0.00 mg (0.00-5.00) and 0.00 mg (0.00-5.00) in women with third-/fourth-degree, first-/second-degree, and no lacerations, respectively, during the 0-48 h postpartum (p < .001).Conclusion: The use of opioids and opioid doses are higher in women with third-/fourth-degree perineal lacerations compared to those with first-/second-degree or no lacerations. [ABSTRACT FROM AUTHOR]

Objective: To develop and characterize innovative vaginal dosage forms for the treatment of bacterial vaginosis (BV). Significance: This study is the first comparative evaluation of the metronidazole (MET)-loaded polyvinylpyrrolidone (PVP) nanofiber formulations on BV treatment. Vaginal nanofibers are one of the potential innovative dosage forms for BV treatment because of their flexible, mucoadhesive, and easy application in vaginal application which can be applied by the mucosal route. Methods: Blank and MET-loaded PVP solutions were prepared at three different concentrations (10, 12.5, 15%) for produce nanofiber. The suitability of the viscosities, surface tensions, and conductivity values of the solutions used to produce nanofibers for the electrospinning process has been evaluated. Scanning electron microscopy, mucoadhesion, permeability, Fourier transform infrared spectroscopy, differential scanning calorimetry, and drug release tests were performed to reveal the physical, chemical, and pharmaceutical properties of the nanofibers. Mechanical properties, and contact angle of the fibers were also determined. Gel and solution formulations containing MET were prepared for comparative studies. Results: All polymer solutions were found to be suitable for electrospinning process. PVP concentration directly affected nanofiber diameter, mechanical, and mucoadhesion properties of nanofibers. The release profiles of the drug from the nanofibers were similar for all concentration of PVP and release from the fibers was rapid. The permeability coefficient of MET from nanofibers was increased more than gel and solution formulations. Conclusions: Vaginal use of MET-loaded nanofibers has been shown to be a potential drug delivery system for the treatment of BV. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate the effects of combined management of placenta previa with the Arabin cervical pessary and progesterone.Study design: In this randomized controlled study, we followed up 217 patients with placenta previa and high risk of preterm birth. The main group (n = 81) underwent combined management with the Arabin cervical pessary and progesterone; the control group (n = 136) received progesterone only. Placental migration was monitored using Doppler scanning from 24 weeks of pregnancy onwards.Results: Patients receiving the combination of the Arabin cervical pessary and progesterone had a three-fold reduced rate of bleeding during pregnancy compared with patients in the control group (11.3% versus 33.1%; p = .006). Placental migration occurred 1.8 times more often in the pessary group (48.1% versus 26.4%; p = .037), and preterm labor <34 weeks occurred 2.7 times less often compared with the control group (p = .031). The use of the Arabin cervical pessary caused a change in the anterior cervico-uterine angle by 7.4 degrees, and reduction in the arcuate artery RI at 32-33 weeks of pregnancy compared with the control group.Conclusions: The use of the Arabin cervical pessary combined with progesterone in patients with placenta previa significantly reduced the rate of preterm delivery <34 weeks and bleeding during pregnancy. [ABSTRACT FROM AUTHOR]

Background and objectives: Childbirth consists of a three-stage period beginning with uterine contractions and ending in the expulsion of the placenta. The present study was conducted to compare the effects of Ringer's solution, dextrose solution 5%, and oral intake on the duration of total labor and labor stages (primary outcome) and the frequency of oxytocin administration and prolonged labor (secondary outcome) in nulliparous women with spontaneous vaginal delivery.Materials and methods: The present randomized clinical trial was conducted on 201 nulliparous women in labor assigned with a randomized block design to three groups, each receiving either Ringer's solution plus oral fluids, dextrose solution 5% solution plus oral fluids or oral fluids alone. The solutions were intravenously administered at a rate of 125 ml/h in the groups receiving the solutions and the subjects in the oral fluids group could consume liquids of their choice (water, orange juice, and apple juice). The duration of total labor and labor stages (the active stage, the second, and third stages of labor) were recorded by the researcher in minutes. Furthermore, the frequency of oxytocin administration and prolonged labor were recorded by the researcher by using a checklist. Data were analyzed using the Kruskal-Wallis test, Mann-Whitney's U-test, chi- square test and Fisher exact test.Results: The mean (±SD) duration of total labor was 301.2 (±50.0) minutes in the Ringer group, 171.9 (±36.4) in the dextrose 5% group, and 524.8 (±103.4) in the oral fluids group, suggesting a statistically significant intergroup difference (p < .001). The mean (±SD) duration of the active stage of labor was 276.7 (±91.3) minutes in the Ringer group, 150.6 (±78.5) in the dextrose 5% group, and 302.4 (±136.8) in the oral fluids group, suggesting a statistically significant intergroup difference (p < .001). A significant difference was also observed between the three groups in terms of the duration of the third stage of labor (p < .001); however, no significant differences were observed in terms of the duration of the second stage of labor (p = .058). Furthermore, a significant difference was observed between the three groups in terms of the need for oxytocin administration (p ≤ .001) and the frequency of prolonged labor (p = .001).Conclusion: The results suggest that the consumption of dextrose solution by nulliparous women reduces the duration of labor, the need for oxytocin administration and the frequency of prolonged labor compared to when Ringer's solution and oral fluids are used. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of misoprostol administration orally or vaginally for cervical ripening in women before operative hysteroscopy surgery. Material and methods: Two hundred seventy-five women eligible for operative hysteroscopy were recruited for a controlled, blinded, randomized trial. Twenty-two women were excluded from the study. Patients were randomly assigned to take 600 µg of misoprostol or 30 mg vitamin B6 orally or vaginally, respectively, 4–12 h before operative hysteroscopy. Main outcome measures: Extent of cervical diameter before the hysteroscopy procedure, need for further cervical dilatation, degree of ease of cervical dilation, duration of additional cervix dilatation and hysteroscopy procedure, abdominal pain prior to surgical procedure, patients' acceptability, complications and associated side effects during the hysteroscopy procedures. Results: Cervical width in the vaginal and oral misoprostol groups after administration was 7.2 ± 0.9 mm and 7.5 ± 1.4 mm, respectively, a statistically significant difference compared to the control group. The duration required for cervical priming with misoprostol, either vaginally or orally (75 ± 24 s or 82 ± 22 s), was significantly shorter than that of placebo (148 ± 31 s). The effect of cervical dilation with misoprostol was significantly higher in the premenopausal participants. Occurrence of uterine false tract substantially increased in the placebo group. Meanwhile, the risk of side-effects increased in the misoprostol-treated patients compared to the control group. Conclusions: The administration of misoprostol seemed more effective than the control for preoperative cervical priming in menstrual participants. Further large randomized controlled trials are needed to determine whether misoprostol could reduce complications with fewer side-effects and to establish whether misoprostol has a substantial cervical dilation effect on either premenopausal or postmenopausal patients. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate improvement of dyspareunia and associated vaginal dryness with a 17β-estradiol softgel vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA) in women with postmenopausal vulvar and vaginal atrophy (VVA). Methods: Postmenopausal women with VVA and moderate to severe dyspareunia received TX-004HR (4, 10, or 25 μg) or placebo in the 12-week, randomized, double-blind, placebo-controlled, phase 3 REJOICE trial. Post hoc analyses examined improvement levels in dyspareunia and concurrent vaginal dryness with TX-004HR and assessed the effects of patient characteristics on vaginal dryness treatment. Results: Significantly more women treated with TX-004HR (all doses) than placebo had complete resolution or substantial improvement in dyspareunia or vaginal dryness (concurrent with dyspareunia) by 12 weeks, observed as early as week 2 with most doses. TX-004HR significantly improved both dyspareunia and vaginal dryness at least one level versus placebo by week 12 in women with both symptoms. Subgroup analyses showed TX-004HR improved vaginal dryness associated with dyspareunia regardless of age, body mass index, uterine status, prior pregnancy, and vaginal birth number. Conclusion: TX-004HR provided clinically meaningful improvements in dyspareunia and vaginal dryness associated with dyspareunia in postmenopausal women with VVA. Clinicians may be able to use this information when discussing patients' expectations regarding symptom improvement with the estradiol vaginal insert. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to qualify relevant factors for vaginal delivery among women who underwent labor induction with vaginal dinoprostone (PGE2) insert in a Chinese tertiary maternity hospital.Material and Methods: A retrospective study was conducted in Hubei Maternal and Child Health Hospital. A total of 1656 pregnancies that underwent labor induction with vaginal dinoprostone insert between January and August 2016 were finally included in this study. Data were analyzed using univariate and multivariable regression modeling.Results: Of 1656 women with PGE2-induced labor at term, 396 (23.91%) gave birth by cesarean section, 1260 (76.09%) had a vaginal delivery among which 921 (55.61%) delivered vaginally within 24 h. Multivariable regression analysis showed that maternal age (p < .001, OR = 0.89, 95%CI 0.85-0.93), parity (multiparous versus nulliparous, p < .001, OR = 8.74, 95%CI 4.36-17.50), baseline fetal heart rate (p = .009, OR = 0.98, 95%CI 0.96-0.99), and birth weight (p < .001, OR = 0.37, 95%CI 0.28-0.51) were significantly correlated with vaginal delivery. Moreover, body mass index (p < .001, OR = 1.11, 95%CI 1.05-1.19), parity (multiparous versus nulliparous, p < .001, OR = 6.57, 95%CI 2.37-18.23), baseline fetal heart rate (p = .004, OR = 0.96, 95%CI 0.94-0.99), and birth weight (p < .001, OR = 0.34, 95%CI 0.21-0.54) were independent predictors of vaginal delivery within 24-h.Conclusions: Our findings suggested a vaginal delivery rate of 76.09% when dinoprostone vaginal insert was used for labor induction, which was markedly higher than the overall annual vaginal delivery rate of 65.1% in China during 2014. Maternal age, parity, baseline fetal heart rate, and birth weight were significant factors for vaginal delivery. This study enables us to better understand the efficiency of dinoprostone and the potential predictors of vaginal delivery in dinoprostone-induced labor, which may be helpful to guide the clinical use of dinoprostone and therefore provide better service clinically. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to compare the uterine activity response between women administered dinoprostone (prostaglandin E2) and misoprostol (prostaglandin E1) for induction of labour (IOL) by analysing not only the traditional obstetric data but also the parameters extracted from uterine electrohysterogram (EHG).Methods: Two cohorts were defined: misoprostol (25-µg vaginal tablets; 251 women) and dinoprostone cohort (10 mg vaginal inserts; 249 women). All the mothers were induced by a medical indication of a Bishop Score < = 6.Results: The misoprostol cohort was associated with a shorter time to achieve active labour (p = .017) and vaginal delivery (p = .009) and with a higher percentage of vaginal delivery in less than 24 h in mothers with a very unfavourable cervix score (risk ratio (RR): 1.41, IC95% 1.17-1.69, p = .002). Successful inductions with misoprostol showed EHG parameter values significantly higher than basal state for amplitude and pseudo Montevideo units (PMU) 60' after drug administration, while spectral parameters significantly increased after 150'. This response was not observed in failed inductions. In the successful dinoprostone group, the duration and number of contractions increased significantly after 120', PMU did so after 180', and no significant differences were found for spectral parameters, possibly due to the slower pharmacokinetics of this drug.Conclusion: Successful inductions of labour by misoprostol are associated with earlier effective contractions than in labours induced by dinoprostone. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to compare the efficacy of labor induction by Foley catheter balloon (FCB) insertion to intravaginal dinoprostone tablet placement in women with an unfavorable cervix.Materials and Methods: A prospective randomized controlled trial was conducted. Women were assigned to insertion of a FCB or placement of a vaginal dinoprostone tablets and their outcome were compared.Results: The study comprised 300 women. The time to active labor was significantly shorter in the FCB compared with the dinoprostone group, but required more oxytocin administration. A lower rate of cesarean section was found only in nulliparous women in the FCB group. The neonatal outcome was favorable and similar in both groups.Conclusion: Both methods had similar results regarding achieving vaginal delivery within 24 h and cesarean section rate. For nulliparous women, the FCB induction method had the advantage of a shorter time to active labor and a lower rate of cesarean section. [ABSTRACT FROM AUTHOR]

The vaginal immune system (VIS) is the first defense against antigens recognized as foreign. Substances capable of locally activating the VIS could be a valid strategy to treat vulvo-vaginal infections (VVI), caused by changes in the vaginal ecosystem, such as bacterial vaginosis (BV), vulvo-vaginal candidiasis (CA), and mixed vaginitis (MV). Bacterial lysates, obtained by crushing bacterial cultures, exert immuno-modulatory activities. The parietal fraction from Propionibacterium acnes is a patent of Depofarma (MoglianoVeneto, Italy). The preparation that associates such fraction to hyaluronic acid and polycarbophil is a registered trademark, commercially available in Italy as vaginal gel, Immunovag®. The study aimed to evaluate whether a 5-day-treatment with Immunovag® improves the symptoms and signs of VVI, in 60 women with Gardnerella vaginalis (GV), 154 with CA, 95 with MV, diagnosed with vulvar vaginal swab (VVS), and in 283 with BV, diagnosed with the Amsel criteria. At the end of the treatment (visit 2), the symptoms and signs of VVI disappeared in a significant number of subjects (χ2p < .02 vs pre-treatment) in all VVI groups, and their intensity was significantly (p < .0002) reduced in the subjects in which they were still present. Immunovag® represents a valid treatment of VVI induced by changes in the vaginal ecosystem. [ABSTRACT FROM AUTHOR]

For prevention of a recurrent preterm birth (PTB), intramuscular 17-α-hydroxy progesterone caproate (IM 17 OHPC) weekly is recommended. Vaginal progesterone is preferred for women at risk for PTB due to a short cervical length, but may be useful in women with a prior PTB. However, there is no consensus about the optimal vaginal formulation or its efficacy as compared to 17 OHPC to prevent recurrent PTB. We randomised 100 women with a singleton pregnancy between 16 and 24 weeks of gestation and ≥ one prior spontaneous PTB, of a singleton (>16 to <37 weeks of gestation) to receive the 200 mg vaginal progesterone effervescent tablet daily (Group A) or IM 17-OHPC, 250 mg weekly (Group B) till 37 weeks of gestation or delivery. The spontaneous PTB rate of <37 weeks was similar (20% in Group A and 20.8% in Group B, p =  .918). The PTB rate of <34 weeks or <28 weeks were also comparable. The mean birth weight and other neonatal outcomes were similar in the two groups. Two neonates in Group A and four neonates in Group B required NICU admission, one of whom (Group B) died due to prematurity. Twenty percent of women in Group A and 29.2% in Group B reported adverse effects from their respective study medications (p =  .408, NS). Thus, there did not appear to be a difference between vaginal progesterone and 17-OHPC when used for the prevention of a recurrent PTB. Impact statement What is already known on this subject? Progesterone administration is useful for prevention of a recurrent preterm birth (PTB) and these women are prescribed the intramuscular 17-α-hydroxy progesterone caproate (IM 17 OHPC), 250 mg, weekly. Some studies found that vaginal progesterone (once daily) is also beneficial in these women, but there is no consensus regarding its efficacy when compared to 17 OHPC, or its optimal formulation and dose. What do the results of this study add? In the present study, 100 women with a singleton pregnancy between 16 and 24 weeks of gestation and ≥ one prior spontaneous singleton PTB or mid-trimester abortion were randomised to receive 200 mg of vaginal progesterone effervescent tablet daily (Group A) or 250 mg IM 17-OHPC weekly (Group B) till 37 weeks of gestation or delivery. The spontaneous PTB rate <37 weeks was similar in the two groups (20% in Group A and 20.8% in Group B, p = .918). The PTB rate <34 weeks or <28 weeks were also comparable. The mean birth weight and other neonatal outcomes were similar. Twenty percent of women in Group A and 29.2% of women in Group B reported adverse effects from their respective study medications (p = .408, NS). Thus, there did not appear to be a difference between the vaginal progesterone effervescent tablet and 17-OHPC when used for the prevention of a recurrent PTB. What are the implications of these findings for clinical practice and/or further research? The vaginal progesterone effervescent tablet may be a suitable alternative to IM 17 OHPC to prevent recurrent PTB. Future studies should identify the most appropriate route (IM or vaginal) and vaginal progesterone formulation for PTB prevention in women at risk for a recurrent PTB and in women with a short cervical length. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of dydrogesterone, 17-OH progesterone (17OHP) and oral or vaginal micronized progesterone with cerclage for the prevention of preterm birth in women with a short cervix.Methods: The study included 95 women with singleton gestation and cervical length (CL) ≤ 25 mm. Among these, 35 women were asymptomatic at 15-24 weeks and 60 had symptoms of threatened late miscarriage (LM) or preterm delivery (PD) at 15-32 weeks. Patients were randomized to receive dydrogesterone, 17OHP or oral/vaginal micronized progesterone; after one week of therapy 15 women underwent cerclage.Results: Efficacy of vaginal progesterone (VP) for the prevention of preterm birth reached 94.1%. In asymptomatic women pregnancy outcomes were comparable to cerclage. In women with threatened LM/PD, combination therapy with VP, indomethacin and treatment of bacterial vaginosis (BV) with the subsequent use VP until 36 weeks together with CL monitoring significantly decreased the rate of preterm birth (RR 0.01; 0.0001-0.24) and low birth weight (LBW) (RR 0.04; 0.01-0.96). CL increase during the first week of treatment with a subsequent plateau phase indicated treatment efficacy. Dydrogesterone, 17OHP, and micronized oral progesterone (OP) were associated with PD in 91.7% of women.Conclusions: Combination management strategy including VP significantly benefits pregnancy outcomes in women with a short cervix compared with cerclage. Dydrogesterone, 17OHP, and OP were not found to be efficacious. [ABSTRACT FROM AUTHOR]

Objective and Design: Prospective randomized controlled trial to test the effectiveness of topical oxytocin gel to improve vaginal atrophy in postmenopausal women.Patients and Methods: A total of 140 postmenopausal women presenting with vaginal atrophy and who satisfied the inclusion and exclusion criteria were randomized into two groups each of 70 patients; they received intravaginal oxytocin gel or placebo gel for 30 days. Serum estrogen level, visual, colposcopic and histological vaginal examination were performed before and after treatment.Results: Forty-seven out of 70 women in the oxytocin gel group improved after treatment and none in the placebo group (p = 0.001). Forty-five participants in the oxytocin group and seven in the placebo group reported relief of dyspareunia (p = 0.001). Thirty-four participants in the oxytocin group and seven in the placebo group reported relief of soreness (p = 0.001). There was no significant difference between the circulating levels of estradiol in both groups before and after treatment (p = 0.4 and 0.6 for the oxytocin group and the placebo group, respectively).Conclusion: Oxytocin gel is useful in the restoration of the vaginal epithelium in cases of postmenopausal atrophic vaginitis. Further studies with a longer follow-up period are required to test the long-term effects of oxytocin as a treatment for vaginal atrophy. [ABSTRACT FROM AUTHOR]

In recent years, a vast quantity of clinical data has been accumulated on the pathophysiology of symptomatic vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM) in peri- and postmenopausal women and on the treatment options for these conditions. Guidelines from several societies have recently been updated in favor of VVA/GSM vaginal therapy with the lowest possible doses of estrogens. The combination of a vaginal ultra-low dose of 0.03 mg of estriol (E3) and lyophilized, viable Lactobacillus acidophilus KS400 (0.03 mg-E3/L) is a unique product with a dual mechanism of action supporting not only the proliferation and maturation of the vaginal epithelium, but also restoration of the lactobacillary microflora. It has been demonstrated efficiently to establish and maintain a healthy vaginal ecosystem. Use of this combination considerably improves the clinical signs and symptoms as well as the quality of life of menopausal women suffering from vaginal atrophy. This combination therapy is well tolerated with a low overall incidence of side-effects and negligible estriol absorption. Based on recent scientific evidence and current treatment guidelines, the 0.03 mg-E3/L combination could be considered one of the options for the treatment of symptomatic vaginal atrophy in aging menopausal women. [ABSTRACT FROM AUTHOR]

Induction of labour (IOL) is a widely-used practice in obstetrics. Our aim was to evaluate predictors of vaginal delivery in postdate pregnancies induced with prostaglandins. We conducted a retrospective cross-sectional study with analytic component. A total of 145 women, admitted for IOL after the 41st week of gestation, were induced with a vaginal pessary releasing prostaglandins. Type of delivery, whether vaginal or caesarean, was the outcome. Several maternal and foetal variables were investigated. The Kaplan-Maier curves, monovariate and a multivariate logistic regression were carried out. In our population, 80.7% of women had vaginal delivery after the induction. Multiparity and a high Bishop score at the beginning of the IOL were protective factors for a vaginal delivery (respectively OR 0.16, p = .028 and OR 0.62, p = .034) while age >35 years, and the foetal birth weight >3500 g at the birth, resulted in being risk factors for caesarean section (respectively OR 4.20, p = .006 and OR 3.63, p = .013). IMPACT STATEMENT What is already known on this subject: Induction of labour (IOL) is a widely used practice in obstetrics. Scientific literature shows several predictors of successful induction, although there is no unanimity except for 'multiparity' and 'favourable Bishop score' which are associated with positive outcome of the induction. The main difficulty in finding other predictive factors is the heterogeneity of this field (different local protocols in each hospital, type of induction, populations and outcomes chosen in each study). In addition to that, populations are not always comparable due to the different gestation. For this reason, we decided to select a specific population of women, such as low risk postterm pregnancies induced with prostaglandins, in order to detect possible predictive factors for the success of the IOL for women with uncomplicated pregnancies. What the results of this study add: Our study agrees with existing literature that 'multiparity' and 'Bishop score' are linked with the success of IOL and adds that 'maternal age' and 'foetal birth weight' are significant risk factors for the population of uncomplicated post term pregnancies induced with prostaglandins. What the implications are of these findings for clinical practice and/or further research: Our results agreed with the existing literature regarding parity and Bishop score but not for maternal age and birth weight. This adds new precious data to the literature which could be used for systematic reviews and for implementing IOL guidelines and protocols, nationally and internationally. Our findings could be also used for guiding future research in this field. It will be interesting to investigate the existence of not just specific factors but also any combination of variables which could predict the success of the procedure. At the moment these information cannot be used in terms of decision making for healthcare professionals as no variable is 100% predictive but once further research will be added, we may be able to know when is best time to start the IOL, how to facilitate the success of the procedure and how to best support the woman throughout the whole experience. [ABSTRACT FROM AUTHOR]

Due to heightened vulnerability to HIV from frequent engagement in sex work and overlapping drug-using and sexual networks, women who inject drugs should be a high priority population for pre-exposure prophylaxis (PrEP) and other biomedical HIV prevention tools. Kenya is one of the first African countries to approve oral PrEP for HIV prevention among "key populations," including people who inject drugs and sex workers. The objective of this study was to explore preferences and perceived challenges to PrEP adoption among women who inject drugs in Kisumu, Kenya. We conducted qualitative interviews with nine HIV-uninfected women who inject drugs to assess their perceptions of biomedical HIV interventions, including oral PrEP, microbicide gels, and intravaginal rings. Despite their high risk and multiple biomedical studies in the region, only two women had ever heard of any of these methods. All women were interested in trying at least one biomedical prevention method, primarily to protect themselves from partners who were believed to have multiple other sexual partners. Although women shared concerns about side effects and product efficacy, they did not perceive drug use as a significant deterrent to adopting or adhering to biomedical prevention methods. Beginning immediately and continuing throughout Kenya's planned PrEP rollout, efforts are urgently needed to include the perspectives of high risk women who use drugs in biomedical HIV prevention research and programing. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association between hypertensive (HTNsive) disorders of pregnancy and outcomes of labor induction, in two cohorts of women induced with either misoprostol vaginal insert (MVI) or dinoprostone vaginal insert (DVI).Study Design: This investigation was a post-hoc analysis of data from three Phase II and III, multi-center, double blind, randomized controlled trials of women induced with identical efficacy endpoints. A competing risk framework investigated the association between HTNsive disorders of pregnancy and the time-to-event endpoints of onset of active labor and vaginal delivery. We analyzed the overall incidence of the competing risk, cesarean delivery, by logistic regression to identify potential differences between the proportion of patients with cesarean and vaginal deliveries for each cohort.Results: 401 women with HTNsive disorders during pregnancy underwent induction of labor in these studies (175 with DVI and 226 with MVI). Significant differences were noted in the cumulative incidence of vaginal delivery 24 hours following insertion between the non-HTNsive and HTNsive groups for both treatments, (57.1% vs. 47.4% (p=0.023) among MVI patients and 39.9% vs. 27.2% (p=0.017) among DVI patients). However, upon adjusting for potential confounders, the estimated relative rates of vaginal delivery among HTNsive vs. non-HTNsive patients was 0.947 (95% CI (0.637, 1.371), p=0.631) and 0.904 (95% CI (0.735, 1.113) p=0.341) within the MVI and DVI sub-groups respectively.Conclusion: After adjustment for confounders, such as BMI, baseline modified Bishop score and gestational age, time-to-event outcomes for induction of labor using MVI or DVI in HTNsive women are not significantly different from non-HTNsive women. [ABSTRACT FROM AUTHOR]

Objective: To evaluate outcomes among pregnancies with cerclage as compared to cerclage and adjunctive progesterone.Methods: A retrospective cohort study was performed from 1 October 2011-30 June 2015 including women with a singleton gestation with vaginal cerclage. Exclusion criteria included multiple gestations, simultaneous 17-alpha hydroxyprogesterone caproate (17-OHPC) and vaginal progesterone (vag-p) use, and patients lost to follow-up. Primary outcome was prevention of preterm birth less than 35 (PTB <35) weeks gestational age (GA).Results: One hundred thirty-six patients met inclusion criteria; 73 women had cerclage only, 53 had cerclage and 17-OHPC, 10 had cerclage and vag-p. GA at cerclage placement was similar across groups (p = 0.068). There was a difference in prevention of PTB <35 weeks GA among groups (p = 0.035) with a trend toward earlier delivery among patients with cerclage and vag-p. Rates of PTB <35 weeks in the cerclage (29%) and cerclage and 17-OHPC groups (34%) were similar (p = 0.533). The odds ratio for risk of PTB <35 weeks among women with cerclage and vag-p as compared to all other patients was 5.21 (95%CI: 1.3-21.2).Conclusion: The combination of cerclage with intramuscular progesterone resulted in similar PTB prevention as compared to cerclage alone. There may be an association between cerclage, vaginal progesterone and higher rates of PTB which may be attributed to characteristics of the group rather than the therapies studied. [ABSTRACT FROM AUTHOR]

Objective: To evaluate outcomes among pregnancies with cerclage as compared to cerclage and adjunctive progesterone.Methods: A retrospective cohort study was performed from 1 October 2011-30 June 2015 including women with a singleton gestation with vaginal cerclage. Exclusion criteria included multiple gestations, simultaneous 17-alpha hydroxyprogesterone caproate (17-OHPC) and vaginal progesterone (vag-p) use, and patients lost to follow-up. Primary outcome was prevention of preterm birth less than 35 (PTB <35) weeks gestational age (GA).Results: One hundred thirty-six patients met inclusion criteria; 73 women had cerclage only, 53 had cerclage and 17-OHPC, 10 had cerclage and vag-p. GA at cerclage placement was similar across groups (p = 0.068). There was a difference in prevention of PTB <35 weeks GA among groups (p = 0.035) with a trend toward earlier delivery among patients with cerclage and vag-p. Rates of PTB <35 weeks in the cerclage (29%) and cerclage and 17-OHPC groups (34%) were similar (p = 0.533). The odds ratio for risk of PTB <35 weeks among women with cerclage and vag-p as compared to all other patients was 5.21 (95%CI: 1.3-21.2).Conclusion: The combination of cerclage with intramuscular progesterone resulted in similar PTB prevention as compared to cerclage alone. There may be an association between cerclage, vaginal progesterone and higher rates of PTB which may be attributed to characteristics of the group rather than the therapies studied. [ABSTRACT FROM AUTHOR]

Objectives:The primary objective of our study was to ascertain whether moistening the Brazilian formulation of vaginal misoprostol tablets increases cervical dilation before manual vacuum aspiration (MVA), compared with use of dry misoprostol, in first-trimester miscarriage. The secondary objective was to ascertain whether there was any correlation between vaginal pH and the degree of cervical dilation using a moistened or dry misoprostol tablet. Methods:In a single-centre, double-blind, randomised trial, 46 patients with first-trimester miscarriage were randomly allocated to treatment with dry or moistened (with 200 µl distilled water) 2 × 200 μg misoprostol tablets. Results:The median (range) cervical dilation in the wet and dry groups was 8 mm (6–12 mm) and 7 mm (5–10 mm), respectively (p = .06). The median time between misoprostol insertion and carrying out the procedure did not differ between the dry (406 min, range 180–550 min) and wet (448 min, range 180–526 min) groups (p = .1). No correlation was found between vaginal pH and cervical dilation using continuous data (p = .57;r= 0.08; 95% confidence interval −0.02, 0.3) or dichotomous data (pH ≤5/>5; cervical dilation ≥8 mm or <8 mm;p = .8). Conclusion:No difference was observed in cervical dilation between moistened and non-moistened misoprostol use prior to MVA. [ABSTRACT FROM PUBLISHER]

Introduction: Abortion is often a difficult and traumatic decision for a woman to make. Perhaps greater distress occurs when a woman commences a medical abortion but then changes her mind and wishes to keep the now-threatened pregnancy. One published case series detailed a potential method to counter/reverse the abortifacient effect of mifepristone by administering parenteral progesterone in such situations.Objectives: The present report details cases of women in similar circumstances who have been treated with progesterone. The aims were to document occurrences of where women have changed their mind after commencing medical abortion, as well as to explore some of the controversies and clinical issues surrounding their circumstances.Methods: Women who had commenced medical abortion by ingesting mifepristone but who had not taken misoprostol independently contacted a national pregnancy support service the same day. Those meeting criteria for treatment received progesterone pessaries per vaginum for two weeks.Results: Cases: 28-year-old woman, 6 weeks plus 1 day gestation; 35-year-old woman, 8 weeks plus 5 days gestation; and 27-year-old woman, 7 weeks plus 3 days gestation. Outcomes respectively were: healthy male baby delivered at 39 weeks gestation; healthy male baby delivered at term; and completed medical abortion.Conclusions: Women have changed their mind after commencing medical abortion. Progesterone use in early pregnancy is low risk and its application to counter the effects of mifepristone in such circumstances may be clinically beneficial in preserving her threatened pregnancy. Further research is required, however, to provide definitive evidence. [ABSTRACT FROM AUTHOR]

Biomedical HIV prevention tools including oral pre-exposure prophylaxis (PrEP) and vaginal microbicidal rings hold unique value for high-risk women who may have limited capacity for condom negotiation, including the key populations of sex workers and drug users. Commercial sex is a PrEP indicator in CDC guidelines, yet little is known about female sex workers' (FSWs) knowledge of and attitudes toward PrEP or the recently developed monthly vaginal microbicide rings. We describe knowledge and attitudes toward PrEP and microbicide rings in a sample of 60 mostly drug-using FSWs in Baltimore, Maryland, a high HIV-prevalence US city. Just 33% had heard of PrEP, but 65% were interested in taking daily oral PrEP and 76% were interested in a microbicide vaginal ring; 87% were interested in at least one of the two methods. Results suggest method mix will be important as biomedical tools for HIV prophylaxis are implemented and scaled up in this population, as 12% were interested in PrEP but not vaginal rings, while 19% were interested in vaginal rings but not in PrEP. Self-efficacy for daily oral adherence was high (79%) and 78% were interested in using PrEP even if condoms were still necessary. Women who had experienced recent client-perpetrated violence were significantly more interested in PrEP (86% vs 53%, p = 0.009) and microbicidal rings (91% vs 65%, p = 0.028) than women who had not recently experienced violence. No differences were observed by demographics nor HIV risk behaviors, suggesting broad potential interest in daily PrEP and monthly-use vaginal microbicides in this high-risk population. [ABSTRACT FROM AUTHOR]

This triple-blind trial examined the effects ofCalendula officinalisvaginal cream on the treatment of vaginalCandidiasis(primary outcome) and sexual function (secondary outcome). Married women aged 18–45 years with vaginalCandidiasis(n= 150) were recruited from April to October 2014 and randomized intoCalendulaand clotrimazole groups, using 5-g vaginal cream every night for seven nights. Clinical and laboratory assessments were conducted at 10–15 and 30–35 days after intervention and the female sexual function index was assessed at 30–35 days. Six women were lost to follow-up. The frequency of testing negative forCandidiasisin theCalendulagroup was significantly lower at the first (49% vs. 74%; odds ratio (OR) 0.32; 95% confidence interval (CI) 0.16–0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5–6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up, but were significantly lower in theCalendulagroup at the second follow-up. Sexual function had almost equal significant improvement in both groups.Calendulavaginal cream appears to have been effective in the treatment of vaginalCandidiasisand to have a delayed but greater long-term effect compared to clotrimazole. [ABSTRACT FROM PUBLISHER]

Objectives: To evaluate efficacy, tolerability and safety of Monurelle Biogel® vaginal gel for treatment of vaginal dryness.Methods: Multicenter, national, randomized, controlled vs. no-treatment, open-label study. Ninety-five postmenopausal women were randomized (48 to Monurelle Biogel® and 47 to no treatment). Primary endpoint was the change of Verbal Rating Scale (VRS) total score of vaginal atrophy (VA) symptoms after 8-week treatment. The main secondary endpoints were VRS single-item score, Vaginal Health Index (VHI) score, Maturation Index (MI), Female Sexual Function Index (FSFI), and Female Sexual Distress Scale-Revised (FSDS-R).Results: The VRS total score was statistically significant in favor of the treatment group on day 28 (p = 0.001) but not on day 56 (p = 0.064). By excluding women who were not sexually active, the total VRS scores reached the criteria for clinical success in 27/43 subjects (62.8%) in the control arm and in 38/46 subjects (82.6%) in the treatment arm (p = 0.035) on day 56. The VHI score significantly changed in the active arm (4.71 ± 4.85 vs. 0.28 ± 1.71) (p < 0.001) on day 56. Even the MI significantly improved, with an increase in the percentage of superficial cells (p = 0.01). The improvements in both VHI and MI were still present at the follow-up visit after the discontinuation of the treatment (day 84). Sexual function and distress showed a statistical significant difference on day 56.Conclusions: Monurelle Biogel® vaginal gel applied twice daily for 8 weeks is effective in relieving vaginal dryness and other VA symptoms. Such a clinical meaningful effect persists at least 4 weeks and is supported by an improvement in the vaginal environment. Trial Registration clinicaltrials.gov Identifier: NCT02994342. [ABSTRACT FROM AUTHOR]

Purpose: Maternal age is an important consideration for antenatal care, labor and delivery. We aimed to evaluate the induction of labor (IoL) failure rates among elderly nulliparous women.Materials and Methods: We conducted a retrospective analysis of all nulliparous women at 34 + 0 to 41 + 6 weeks, undergoing cervical ripening by prostaglandin E2 (PGE2) vaginal insert. Study group included elderly (≥35 years) nulliparous and control group included non-elderly (<35 years) nulliparous women. Primary outcome was IoL failure rate and secondary outcome was cesarean delivery rate. Outcomes were compared between the groups by univariate analysis followed by regression analysis to adjust results to potential confounders.Results: Of 537 women undergoing IoL, 69 (12.8%) were elderly. The univariate analysis demonstrated no difference in IoL failure rate (26.5% versus 34.8%, p = 0.502) between groups. However, elderly nulliparous women had higher rates of cesarean delivery (36.2% versus 21.4%, p = 0.009). This difference was no longer significant after adjustment for maternal body mass index, indication for delivery, birth weight and gestational age at delivery.Conclusion: Among nulliparous women, older maternal age is not associated with higher rates of IoL failure or cesarean deliveries. [ABSTRACT FROM AUTHOR]

Purpose: To determine the success rate of induction of labor (IOL) using Foley transcervical balloon (FTB) versus prostaglandin E2 (PGE2) vaginal insert, following failure of cervical ripening with PGE2 vaginal insert.Materials and Methods: A retrospective cohort study of all pregnant women admitted for IOL with either FTB or PGE2 vaginal insert. Either second dose of PGE2 vaginal insert or FTB was used as a second line treatment after failure (not giving birth in 24 h from insertion) of first PGE2 vaginal insert.Results: During the study period, 1162 women were admitted for IOL. Failure was reported in 322/852 (37.8%) in the FTB versus 162/310 (52.2%) in the PGE2 group (p < 0.001). Among 162 patients treated with PGE2 as first line who did not deliver after 24 h, 14 had spontaneous rupture of membranes, 15 underwent stripping and 42 were in still in active labor. The remainder were allocated to either second trial of PGE2 treatment (n = 58) or FTB (n = 33) with failure rate higher in the PGE2 group, not statistically significant (p = 0.23).Conclusion: IOL with FTB was not superior to PGE2 vaginal insert for IOL following failure of cervical ripening with PGE2 vaginal insert. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the efficacy and safety of estriol for the treatment of vulvovaginal atrophy in postmenopausal women.Methods: A systematic literature review was performed. We searched the following electronic databases: Medline, Cochrane, Embase, Lilacs, CINHAL and Google Scholar. The studies selected included controlled clinical trials and quasi-experimental studies. Selections were made in pairs and independently, first by title and abstract and then complete texts.Results: We identified 188 studies, 22 of which met the inclusion criteria; 13 were controlled clinical trials and nine were quasi-experimental, and 1217 women were included. These studies confirmed the efficacy of local estrogens to treat symptoms of vulvovaginal atrophy with few adverse effects reported. Following treatment, serum estriol levels rose, peaking at 1 h. At the 6-month follow-up, there was no increase in serum estriol in treated women.Conclusions: The available evidence (of low and moderate quality) shows that, when administered vaginally, estriol preparations appear to be safe for women who have risk factors related to systemic estrogen therapy. [ABSTRACT FROM AUTHOR]

The present study investigated maternal and neonatal outcomes in pregnant women who used obstetric lubricant gels during active labour. This prospective randomised controlled study included 180 pregnant women. Women were randomly assigned to two groups during the first-stage of labour. Pregnant women in the obstetric gel group received standard antepartum care plus vaginal application of obstetric gel. Women in the control group received standard antepartum care without obstetric gel. Mean duration of the second stage of labour was significantly shorter in the obstetric gel group than control group (45 ± 34 min vs. 58 ± 31 min, respectively;p = .005). Mean APGAR values at 5 min were significantly higher in the obstetric gel group (9.5 ± 0.6 vs. 9.2 ± 0.7;p = .0014). Among nulliparous women, mean duration of the second stage of labour was significantly shorter in the gel group than control group (53 ± 52 min vs. 83 ± 45 min, respectively;p = .003). Using obstetric gel at the beginning of the first stage decreases the length of the second stage of labour, particularly in nulliparous women, and may be associated with an improved APGAR score at 5 min.Impact statementA limited number of studies in the literature have demonstrated that obstetric gels shorten the second stage of labour and are protective for the pelvic floor. The results of this study show that using obstetric gel shortens the second stage of labour in only nulliparous, but not multiparous women. In addition, a significant improvement in the 5 min APGAR score was seen in the neonates of women who used obstetric gel. The application of obstetric gels during the labour of nulliparous women may be a useful clinical practice and may have a widespread use in the future. [ABSTRACT FROM PUBLISHER]

Objective: The objective of this study is to understand the prevalence of short cervical length between 20 and 24 weeks gestation in China and to evaluate the efficacy of micronized progesterone for prolonging gestation in nulliparous patients with a short cervix.Methods: From May 2010 to May 2015, a total of 25 328 asymptomatic women with singleton pregnancies at Peking University First Hospital had their cervical length routinely measured between 20 and 24 weeks of gestation. A cervical length of 25 mm or less was defined as a shortened cervical length. The therapies prescribed include vaginal micronized progesterone capsules (200 mg each night) or bed rest from 20 to 34 weeks of gestation. The primary outcome was spontaneous delivery before 33 weeks.Results: (1) One hundred fourteen women had a cervical length of ≤25 mm (0.45%). (2) Twenty-nine of which with previous spontaneous preterm delivery or late pregnancy loss had cervical cerclage, the remaining 85 women by the use of vaginal progesterone or simply resting activity restriction to prevent preterm birth. (3) In 85 nulliparous women treated by progesterone or bed rest, progesterone use in cervical length between 10 and 20 mm was associated with a statistically significant reduction in the incidence of preterm birth at <33 weeks of gestation (9.5% versus 45.5%, p = 0.02) compared with bed rest. There were no significant differences in cervical length between 20 and 25 mm in their rates of spontaneous preterm delivery at <33 (5.3% versus 3.2%, p = 0.72), <37 (33.3% versus 54.5%, p = 0.25), or <35 weeks (14.3% versus 45.5, p = 0.06) of gestation between vaginal progesterone and bed rest.Conclusion: The rate of short cervical length was less than expected. Vaginal progesterone is efficacious for the prolonging of gestation in women with a cervical length of 10-20 mm in the mid-trimester for a singleton gestation and nulliparous women. For a cervical length of 20-25 mm in the mid trimester, vaginal progesterone compared with bed rest did not prolong pregnancy. [ABSTRACT FROM AUTHOR]

Purpose: Assess the impact of obesity on successful cervical ripening with mechanical versus prostaglandin ripening.Materials and Methods: We compared obese to non-obese women in an analysis stratified by induction method, prostaglandin versus mechanical. Misoprostol dosing was the same for obese and non-obese women. Pitocin was titrated to effect. Our primary outcome was failure to achieve active labor. Secondary outcomes included overall cesarean delivery rate, doses of misoprostol used and need for protocol deviation.Results: Obese women had a higher cesarean delivery rate with misoprostol (35% versus 26%, p = 0.03) but not with mechanical ripening (31% versus 29%, p = 0.69). Obesity was associated with a higher rate of failure to achieve active labor in women undergoing prostaglandin ripening with misoprostol (24 versus 15%, p = 0.01) but not in women undergoing mechanical ripening (19 versus 15%, p = 0.55). After controlling for confounding variables, obese women who underwent cervical ripening with misoprostol had a higher rate of failure to achieve active labor, aOR 1.29 (95%CI: 1.00-1.67), which was not seen with mechanical ripening, aOR 1.09 (95%CI: 0.69-1.73).Conclusion: Obese women receiving the same dose of misoprostol as non-obese women have higher rates of failure to achieve active labor, an effect not seen with mechanical ripening. [ABSTRACT FROM AUTHOR]