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Background Objectives Search Strategy Selection Criteria Data Collection and Analysis Main Results Conclusion Misoprostol is largely used in labor induction in cases of intrauterine fetal death. However, recent randomized clinical trials (RCTs) showed that the combination of mifepristone and misoprostol might have better effects than the use of misoprostol alone.To compare mifepristone and misoprostol lines of treatment.Pubmed, Embase, Cochrane and Web of Science databases were systematically searched until April 9, 2024.The eligibility criteria were (1) RCT, (2) comparing misoprostol alone versus the combined treatment, (3) patients undergoing labor induction due to intrauterine fetal death and (4) reporting at least one relevant outcome.Data were examined using the Mantel–Haenszel method and 95% CIs. Heterogeneity was assessed using I2 statics. R, version 4.2.3 was used for statistical analysis. The analyzed outcomes were delivery time interval, adverse effects (fever, vomiting, diarrhea and nausea) and the preinduction Bishop score. Other important outcomes, such as uterus rupture, could not be included due to lack of data from the included studies.A total of seven RCTs comprising 599 patients with intrauterine fetal death were randomized to misoprostol or combined treatment to induce labor. Compared to the misoprostol only group, combined treatment presented lower delivery time interval (MD –6.86 h; 95% CI: −10.32 to −3.4; P = 0.0001; I2 = 87%). However, in terms of adverse effects, the combined treatment group presented lower occurrence of fever (2.25% vs 12.12%; RR 0.26; 95% CI: 0.09–0.74; P = 0.01; I2 = 0%) and vomiting (7.64% vs 14.45%; RR 0.54; 95% CI: 0.29–1.01; P = 0.05; I2 = 0%). No statistically significant differences were observed when comparing the preinduction Bishop score of the two groups (MD –0.09; 95% CI: −0.28–0.10; P = 0.35; I2 = 0%). Additionally, the mean of the preinduction Bishop score of the combined treatment was 2 versus 2.1 of the control group.In this updated meta‐analysis, consistent results suggest that the combined treatment is associated with more beneficial outcomes than the misoprostol alone treatment in patients undergoing labor induction in intrauterine fetal death. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion To compare perinatal outcomes in subsequent pregnancies following second‐trimester abortions, stratified by the method of abortion.A historic cohort study was conducted in a single tertiary hospital, including women who had second‐trimester abortions between 12+0 and 24+0 weeks and subsequent documented pregnancies within 3–60 months. Data were collected from hospitalization and perinatal databases. Composite outcome variables were constructed, and multivariable logistic regression was used to analyze associations, adjusting for confounders.Among 771 women meeting the inclusion criteria, 83% had surgical abortions and 17% had medical abortions. Medical abortion was associated with a higher incidence of placenta‐associated pregnancy complications compared with surgical abortion. No significant differences were found in other perinatal outcomes.The study highlights the potential influence of the abortion method on subsequent pregnancy outcomes, particularly regarding placenta‐associated complications. This underscores the importance of considering the method of second‐trimester abortion in counseling women regarding potential risks to subsequent pregnancies. Adverse outcomes in subsequent pregnancies following second‐trimester abortion were associated with the medical method of abortion, warranting further research and careful counseling in clinical practice. [ABSTRACT FROM AUTHOR]

Objective: The present study aimed to evaluate low‐dose oral misoprostol induction, and compare different methods used in second‐line induction in patients with a Bishop score less than 6. Methods: This retrospective study analyzed the medical history and courses of pregnancy of all patients induced with first‐line of low‐dose oral misoprostol (50 μg every 4 h with a total of 200 μg/24 h) from April 2021 to June 2022 in a university hospital center, and reported outcomes according to the second‐line method of induction. Results: Among 437 labor inductions with low‐dose oral misoprostol, 120 patients required a second‐line induction. Predictive factors of first‐line failure were higher body mass index (P = 0.011), absence of premature rupture of membranes (P = 0.021) and earlier term of pregnancy (P < 0.001). Regarding second methods of induction of labor, time from induction to delivery was shorter in the oxytocin group than the dinoprostone and misoprostol groups (24.0 vs. 41 and 51.0 h, respectively; P < 0.001), and was also significantly shorter in the dinoprostone than the misoprostol group (P = 0.048). Cesarean section rates did not differ between the three groups (P = 0.651). There were no clinically significant differences in adverse events between the groups. Conclusion: Normal body mass index, previous rupture of membranes and later term of induction of labor were the three favoring success factors during first‐line oral misoprostol. In cases of a Bishop score <6, oxytocin may be the best option to reduce duration to delivery, with the same maternal‐fetal outcomes, including a similar rate of vaginal delivery. Synopsis: If a Bishop score was <6 after 24 h oral misoprostol, oxytocin could be the best method to reduce duration to delivery. [ABSTRACT FROM AUTHOR]

Objective: The study aims to assess how oral misoprostol for cervical ripening affects the time of cesarean delivery (CD) for fetal heart rate (FHR) abnormalities in pre‐eclampsia patients. Secondary goals include determining the role of uterine hyperstimulation, comparing misoprostol with Foley catheter, and identifying risk factors for FHR abnormalities associated with CD. Methods: A previously published randomized clinical trial was subjected to a secondary analysis (NCT01801410). We conducted a time‐dependent analysis, stratifying the population based on the final mode of induction used (low‐dose oral misoprostol vs Foley catheter). Results: There was no CD for FHR abnormalities within 2 h of starting misoprostol. At 5 h, the cumulative incidence of CD for FHR abnormalities in the misoprostol group was 2.10%, while it was 1.00% in the Foley group (P = 0.565). After 25 h, the CD risk for FHR abnormalities remained constant in both groups at 21.00% (95% confidence interval [CI] 15.00%–28.00%). Within 5 h of misoprostol induction, the risk of uterine hyperstimulation was similar in both groups (0.33% in misoprostol vs 0.34% in Foley group, P = 0.161). The risk of CD for FHR abnormalities was unaffected by newborn weight centiles. Conclusion: There was no significant difference in CD risk for FHR abnormalities between misoprostol and Foley catheter induction. Nonetheless, the cumulative incidence of CD for FHR abnormalities increased faster in the misoprostol group, indicating that FHR monitoring timing should be tailored to the induction method. Synopsis: The incidence of cesarean delivery for fetal heart anomalies increased faster in the misoprostol group than in Foley group, and for that reason tailoring fetal monitoring timing to induction method is critical. [ABSTRACT FROM AUTHOR]

Background: To what extent traditional Chinese medicine (TCM) combined with mifepristone and misoprostol is beneficial for improving the complete abortion rate and duration of vaginal bleeding has been a subject of debate in the field of medical abortion. Objective: To assess the evidence regarding the complete abortion rate and duration of vaginal bleeding of medical abortion assisted by different kinds of TCM. Search Strategy: We searched electronic databases such as PubMed, Web of Science and Cochrane Library database, China National Knowledge Internet, Wan fang Database, VIP Database, and China Biology Medicine disc from 2000 to February 15, 2023. Selection Criteria: The control group was medical abortion with mifepristone and misoprostol, and the experimental group was medical abortion assisted by TCM. Data Collection and Analysis: Major data extraction included sample size, age, medicine used for abortion, outcome measures. RevMan 5.3 and Stata 15.1 software were used to assess the literature quality and perform network meta‐analysis, respectively. Main Results: A total of 73 randomized controlled trials (RCTs) with 11 683 patients and nine kinds of TCM were included in this study. Compared with mifepristone and misoprostol, eight kinds of TCM had statistical significance in improving the complete abortion rate. The effect value of Sancao decoction was 5.86 (95% confidence interval [CI] 2.53–13.58). Seven kinds of TCM shortened the duration of vaginal bleeding. The effect value of comfrey and trichosanthin decoction was −8.75 (95% CI –10.86 to −6.64). Conclusions: This network meta‐analysis showed that Lenge Zhumo decoction and Sancao decoction could have a large beneficial effect on complete abortion rate in medical abortion during early pregnancy, and comfrey and trichosanthin decoction could be the best TCM for shortening the duration of vaginal bleeding. Synopsis: As a supplementary drug for medical abortion, traditional Chinese medicine can improve the rate of complete abortion and shorten the duration of vaginal bleeding. [ABSTRACT FROM AUTHOR]

Objective: Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low‐ and middle‐income countries (LMIC). Methods: The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone. Results: Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty‐four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol‐only and seven mifepristone‐only products. Overall, 54.7% of samples were non‐compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol‐only product was found. Conclusion: The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues. Synopsis: Over half of mifepristone, misoprostol, and combipack samples collected and tested did not meet one or more requirements. One product was falsified. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy of lidocaine–prilocaine (LP) cream versus misoprostol versus placebo before levonorgestrel‐releasing intrauterine device (LNG‐IUD) insertion. Methods: This randomized controlled trial (RCT) was conducted in a tertiary referral hospital from April 30, 2020 to March 1, 2021 on 210 parous women willing to receive LNG‐IUD and delivered only by elective cesarean delivery (CD). Participants received 200 μg vaginal misoprostol or 5 ml of LP cream 5% or placebo 3 h before LNG‐IUS insertion. Primary outcome was pain during LNG‐IUD insertion, while secondary outcomes were pain 10 min post‐procedure, ease of insertion, patient satisfaction, insertion time, and drug side effects. Results: Pain during LNG‐IUS insertion was reduced in LP group and misoprostol group compared to placebo group (2.1 ± 1.0 vs 3.7 ± 1.6; p <0.001) and (2.3 ± 1.3 vs 3.7 ± 1.6; p <0.001), respectively. Ease of procedure and patient satisfaction were significantly higher in LP and misoprostol groups than placebo (P <0.001). Need for additional analgesia was significantly higher in placebo group than in the other two groups (P = 0.009). Adverse events were not significantly different between the three groups except vomiting and abdominal cramps, which were higher with misoprostol. Conclusion: LP cream and 200 μg of vaginal misoprostol administration before LNG‐IUD insertion in women delivered only by elective CD effectively reduced pain during insertion and 10 min post‐procedure with easier insertions, high patient satisfaction, and tolerable side effects. Pain reduction with LP cream was clinically significant. Synopsis: Lidocaine–prilocaine cream and vaginal misoprostol are effective and well‐tolerated in reducing LNG‐IUD insertion pain and difficulty. [ABSTRACT FROM AUTHOR]

The UK is usually viewed as having liberal abortion regulations, providing good access to abortion care within a publicly funded health service. However, the underlying laws are authoritarian, dating from an era when public executions drew large crowds and 67 years before women were able to vote. Abortion is only legal when two doctors certify it meets the permitted grounds, and the penalty for self‐managed abortion is up to life imprisonment for both the woman and any accomplice. These laws had prevented the use of mifepristone and misoprostol at home. Changes to the regulations for misoprostol in 2018 and mifepristone in 2020 permitted home use, but the government announced they were rescinding the approval for mifepristone in 2022. This article discusses how, despite the opposition of government, significant progressive changes to the abortion laws were achieved. Early medical abortion at home is now protected in law, and safe access zones protect patients and staff from harassment and intimidation from protesters. Despite this progress, increasing numbers of women are facing criminal investigation and face long prison sentences if convicted. The need for decriminalization and for abortion care to be regulated like all other health care is the next pressing issue. Synopsis: How the most progressive changes to abortion laws in 50 years in the UK were won, and why decriminalization is now an urgent priority. [ABSTRACT FROM AUTHOR]

Background: Misoprostol is widely used for cervical ripening and labour induction as it is heat‐stable and inexpensive. Oral misoprostol 25 μg given 2‐hourly is recommended over vaginal misoprostol 25 μg given 6‐hourly, but the need for 2‐hourly fetal monitoring makes oral misoprostol impractical for routine use in high‐volume obstetric units in resource‐constrained settings. Objectives: To compare the efficacy and safety of oral misoprostol initiated at 25 or 50 μg versus 25 μg vaginal misoprostol given at 4‐ to 6‐hourly intervals for labor induction in women at or beyond term (≥ 37 weeks) with a single viable fetus and an unscarred uterus. Search Strategy: We identified eligible randomized, parallel‐group, labor‐induction trials from recent systematic reviews. We additionally searched PubMed, Cochrane CENTRAL, Epistemonikos, and clinical trials registries from February 1, 2020 to December 31, 2022 without language restrictions. Database‐specific keywords for cervical priming, labor induction, and misoprostol were used. Selection Criteria: We excluded labor‐induction trials exclusively in women with ruptured membranes, in the third trimester, and those that initiated misoprostol at doses not specified in the review's objectives. The primary outcomes were vaginal birth within 24 h, cesarean section, perinatal mortality, neonatal morbidity, and maternal morbidity. The secondary outcomes were uterine hyperstimulation with fetal heart rate changes, and oxytocin augmentation. Data Collection and Analysis: Two or more authors selected studies independently, assessed risk of bias, and extracted data. We derived pooled weighted risk ratios with 95% confidence intervals (CIs) for each outcome, subgrouping trials by the dose and frequency of misoprostol regimens. We used the I2 statistic to quantify heterogeneity and the random‐effects model for meta‐analysis when appropriate. We used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach to assess certainty (confidence) in the effect estimates. Main Results: Thirteen trials, from Canada, India, Iran, and the US, randomizing 2941 women at ≥37 weeks of gestation with an unfavorable cervix (Bishop score <6), met the eligibility criteria. Five misoprostol regimens were compared: 25 μg oral versus 25 μg vaginal, 4‐hourly (three trials); 50 μg oral versus 25 μg vaginal, 4‐hourly (five trials); 50 μg followed by 100 μg oral versus 25 μg vaginal, 4‐hourly (two trials); 50 μg oral, 4‐hourly versus 25 μg vaginal, 6‐hourly (one trial); and 50 μg oral versus 25 μg vaginal, 6‐hourly (two trials). The overall certainty in the evidence ranged from moderate to very low, due to high risk of bias in 11/13 trials (affecting all outcomes), unexplained heterogeneity (1/7 outcomes), indirectness (1/7 outcomes), and imprecision (4/7 outcomes). Vaginal misoprostol probably increased vaginal deliveries within 24 h compared with oral misoprostol (risk ratio [RR] 0.82, 95% CI 0.70–0.96; 11 trials, 2721 mothers; moderate‐certainty evidence); this was more likely with 4‐hourly than with 6‐hourly vaginal regimens. The risk of cesarean sections did not appreciably differ (RR 1.00, 95% CI 0.80–1.26; 13 trials, 2941 mothers; very low‐certainty evidence), although oral misoprostol 25 μg 4‐hourly probably increased this risk compared with 25 μg vaginal misoprostol 4‐hourly (RR 1.69, 95% CI 1.21–2.36; three trials, 515 mothers). The risk of perinatal mortality (RR 0.67, 95% CI 0.11–3.90; one trial, 196 participants; very low‐certainty evidence), neonatal morbidity (RR 0.84, 95% CI 0.67–1.06; 13 trials, 2941 mothers; low‐certainty evidence), and maternal morbidity (RR 0.83, 95% CI 0.48–1.44; 6 trials; 1945 mothers; moderate‐certainty evidence) did not differ appreciably. The risk of uterine hyperstimulation with fetal heart rate changes may be lower with oral misoprostol (RR 0.70, 95% CI 0.52–0.95; 10 trials, 2565 mothers; low‐certainty evidence). Oxytocin augmentation was probably more frequent with oral compared with vaginal misoprostol (RR 1.29, 95% CI 1.10–1.51; 13 trials, 2941 mothers; moderate‐certainty evidence). Conclusions: Low‐dose, 4‐ to 6‐hourly vaginal misoprostol regimens probably result in more vaginal births within 24 h and less frequent oxytocin use compared with low‐dose, 4‐ to 6‐hourly, oral misoprostol regimens. Vaginal misoprostol may increase the risk of uterine hyperstimulation with fetal heart changes compared with oral misoprostol, without increasing the risk of perinatal mortality, neonatal morbidity, or maternal morbidity. Indirect evidence indicates that 25 μg vaginal misoprostol 4‐hourly may be more effective and as safe as the recommended 6‐hourly vaginal regimen. This evidence could inform clinical decisions in high‐volume obstetric units in resource‐constrained settings. Synopsis: Vaginal misoprostol 25 μg 4‐hourly may be an effective, safe, and pragmatic alternative to currently recommended labor‐induction regimens in high‐volume obstetric units in resource‐constrained settings. [ABSTRACT FROM AUTHOR]

Objective: In 2018, the Department of Health and Social Care in England approved the use of misoprostol at home for early medical abortions, following administration of mifepristone at clinic. The objective of the present study was to assess the impact of the approval of home administration of misoprostol in England on access to medical abortion, assessed through proxy measures of the proportion of all abortions that were medical and gestational age. Methods: This study uses the clinical data from the British Pregnancy Advisory Service on abortions in England in years 2018–2019, containing demographic and procedure characteristics of patients. We conducted an interrupted time series analysis to establish the differences before and after the approval in access to medical abortion, measured by the proportion of all abortions that were medical, and gestational age. The analysis also examined whether these changes were equitable, with focus on area‐level deprivation. Results: The analysis of the data (145 529 abortions) suggested that there was an increase in the proportion of medical abortions and decrease in gestational age of abortions after the approval. Compared with the situation if former trends had continued, the actual proportion of early medical abortions was 4.2% higher in December 2019, and the mean gestational age 3.4 days lower. We found that the acceleration of existing trends in increase in proportion of medical abortions and decrease in gestational age were larger in the most deprived quintiles and in those reporting a disability, but not equal across ethnic groups, with Black and Black British women experiencing little change in trajectories post‐approval. Conclusion: The approval of home use of misoprostol as part of an early medical abortion regimen in England was associated with material and equitable improvements in abortion access. Pre‐approval trends toward greater uptake of medical abortion and declining gestational age were accelerated post‐approval and were greatest in the most deprived areas of England, but not across all racial/ethnic groups. The present findings strongly support the continuation or introduction of home management of medical abortions. Synopsis: Home use of misoprostol in medical abortions in England was associated with improvements in abortion access: higher proportion of medical abortions and lower gestational age. [ABSTRACT FROM AUTHOR]

Objective: To assess the knowledge and views of trainee obstetrician‐gynecologists (ObGyn) on abortion. Methods: A cross‐sectional study of trainee ObGyn was conducted by the World Association of Trainees in Obstetrics and Gynecology. A study‐specific questionnaire designed using Google Forms® was utilized for the study. The questionnaire was distributed electronically to study participants, to gather information on their sociodemographic characteristics, opinions, knowledge, and training on abortion. Collected data were analyzed using the IBM SPSS, version 25. Results: Most (140, 74.8%) trainee ObGyn reported that abortion was legal in their countries and most (171, 91.4%) supported the legalization of abortion. Eleven (5.9%) trainees who did not support the legalization of abortion cited religious concerns as their most common reason (5/11, 45.5%). Nearly three‐quarters (133, 71.1%) of the trainees would perform an abortion on request. Most of the trainees reported that abortion education was included in the medical school curricula (131, 70.1%) and the ObGyn residency training programs (155, 82.9%) in their countries. Notwithstanding, 36.4% (68) either did not know or did not correctly know the legal status of abortion in their countries. Conclusion: There is some disparity between ObGyn trainees' knowledge of safe abortion and their awareness of the legality of the same in their countries. There is a need for all countries to include abortion education in the curricula of medical schools and all ObGyn residency programs should offer abortion training to all residents. There is a need for increased advocacy for the legalization of abortion in countries where abortion remains criminalized. Synopsis: Most trainees agree with safe abortion and termination of pregnancy and also know how to perform this treatment. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of using a combination of transcervical Foley catheter and sublingual misoprostol with sublingual misoprostol alone for induction of labor (IOL) in women with pre‐eclampsia between 28 and 34 weeks of pregnancy. Methods: This randomized controlled trial was conducted on women with pre‐eclampsia at 28–34 weeks of pregnancy, with unfavorable cervix, admitted to a tertiary hospital in south India. They were randomized to receive either a combination of transcervical Foley catheter and sublingual misoprostol, or sublingual misoprostol alone. Vaginal birth within 24 h of induction, induction to delivery interval, and neonatal morbidity/mortality were the main outcome measures. Results: Vaginal birth within 24 h was higher with the combination of Foley catheter and sublingual misoprostol compared with sublingual misoprostol alone (60% versus 41.4%, P = 0.028). Overall vaginal delivery rates were comparable between the groups (90% versus 80%, P = 0.051). There was no difference in number of doses of misoprostol, and induction to delivery interval between groups. After excluding those with lower likelihood of neonatal survival, live birth rates, mean birth weight, and neonatal intensive care unit admission rates were similar in both groups. Conclusions: Combination of transcervical Foley catheter and sublingual misoprostol was found to be more effective in achieving vaginal birth within 24 h compared with sublingual misoprostol for IOL in pre‐eclampsia between 28 and 34 weeks of pregnancy. Trial Registration Number: CTRI/2018/09/015766; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=27984. Synopsis: Combination of Foley catheter and sublingual misoprostol appears to be more effective than sublingual misoprostol alone for induction of labor in pre‐eclampsia.T [ABSTRACT FROM AUTHOR]

Objective: To compare maternal and neonatal outcomes between oxytocin and vaginal misoprostol induction in women with term prelabor rupture of membranes (PROM) and unfavorable cervixes. Methods: In this retrospective study, 589 pregnant women with term singleton fetuses in cephalic presentation, reactive nonstress tests, PROM of 2–24 h duration, Bishop score <6, and no previous uterine surgery were reviewed and divided into oxytocin (n = 301) and misoprostol (n = 288) groups. The primary outcomes were the rate of vaginal delivery and delivery within 24 h. Results: After 24 h of induction, the misoprostol group showed a significantly higher proportion of vaginal delivery (64.6% vs. 49.5%, P < 0.001) and a lower cesarean section delivery rate (11.5% vs. 25.2%, P < 0.001) than the oxytocin group. More primiparas in the misoprostol group achieved vaginal delivery within 24 h than in the oxytocin group (60.5% vs. 45.4%, P = 0.001). Among primiparas, the misoprostol group had a significantly lower cesarean delivery rate (12.6% vs. 27.5%, P < 0.001). Conclusion: Vaginal misoprostol induction in term PROM gravidas with unfavorable cervixes was associated with lower cesarean section and higher vaginal delivery rates within 24 h than oxytocin infusion. Vaginal misoprostol and oxytocin infusion had similar maternal and neonatal outcomes. Synopsis: This retrospective study showed that vaginal misoprostol was more effective in induction and vaginal delivery for women with term PROM and unfavorable cervixes. [ABSTRACT FROM AUTHOR]

Objective: To study the rate of surgical intervention for unsuccessful medical treatment in early pregnancy loss (EPL), according to gestational size by ultrasound (GS‐US). Methods: This was a retrospective cohort study. All women who were treated with misoprostol for EPL between July 2015 and December 2020 were included. The cohort was divided according to GS‐US: group 1: gestational sac without an embryonic pole; group 2: an embryonic pole with crown‐rump length (CRL) compatible with <7 weeks; group 3: CRL compatible with 7+0–7+6 weeks; group 4: CRL compatible with 8+0–8+6 weeks; group 5: CRL compatible with ≥9 weeks. We compared the rate of any surgical intervention due to treatment failure. Results: Overall, 783 patients were included: group 1, 236 (30.1%); group 2, 319 (40.7%); group 3, 115 (14.7%); group 4, 78 (10.0%); and group 5, 35 (5.0%) patients. The rate of any surgical intervention was significantly lower in groups 1–4 (54, 22.9%; 85, 26.6%; 28, 24.3%; and 22, 28.2%, respectively) compared with group 5 (17, 48.6%; P = 0.030). On multivariant analysis, GS‐US greater than 9 weeks was independently associated with the need for surgical intervention (adjusted odds ratio 1.23, 95% confidence interval 1.01–1.51; P = 0.040). Conclusion: When treating EPL medically, GS‐US greater than 9 weeks increases the risk of undergoing additional surgical intervention compared with younger weeks. Synopsis: When treating missed abortions medically, gestational size of 9 weeks or more increases the risk of undergoing additional surgical intervention compared with younger weeks. [ABSTRACT FROM AUTHOR]

RETRACTION: A. S. R. Souza, F. E. L. Feitosa, A. A. R. Costa, A. P. R. Pereira, A. S. Carvalho, R. M. Paixão, L. Katz, M. M. R. Amorim, “Titrated Oral Misoprostol Solution Versus Vaginal Misoprostol for Labor Induction,” International Journal of Gynecology & Obstetrics 123, no. 3 (2013): 207–212, https://doi.org/10.1016/j.ijgo.2013.06.028.The above article, published online on 03 September 2013, in Wiley Online Library (http://onlinelibrary.wiley.com/), has been retracted by agreement between the authors; the journal Editor‐in‐Chief, Michael Geary; the International Federation of Gynecology and Obstetrics; and John Wiley & Sons Ltd. The authors reported to the journal that, when analyzing data for a systematic review, they detected that their database contained duplicate patient data. The authors also stated that they have attempted to identify the source of the error, but were unable to confirm the results as the original patient data are no longer available. The retraction has been agreed to because the evidence of duplications in patient data fundamentally compromises the parties' confidence in the results presented in this article. [ABSTRACT FROM AUTHOR]

M. S. E. Elsedeek, “Impact of Preoperative Rectal Misoprostol on Blood Loss During and After Elective Cesarean Delivery,” International Journal of Gynecology & Obstetric 118, no. 2 (2012): 149–152, https://doi.org/10.1016/j.ijgo.2012.03.038.The above article, published online on 13 June 2012 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor‐in‐Chief, Michael Geary; the International Federation of Gynecology and Obstetrics; and John Wiley & Sons Ltd. The retraction has been agreed following an investigation based on concerns raised by a third party. The editors found that the majority of the statistical results presented in Table 1 and 2 could not be reproduced from the summary data reported in the paper. These inaccuracies could not be attributed to rounding. The author was invited to comment on the concerns and provide supporting data but did not respond. The editors consider the results and conclusion reported in this article unreliable. [ABSTRACT FROM AUTHOR]

The document titled "Expression of Concern: Carbetocin versus rectal misoprostol for management of third stage of labor among women with low risk of postpartum hemorrhage" raises concerns about inconsistencies in the clinical trial registration date of a study published in the International Journal of Gynecology & Obstetrics. The authors acknowledged an error in the original registration year and stated that the clinical trial was prospectively registered. However, they were unable to provide ethical approval, patient consent documentation, and raw data for review due to the study being conducted more than 5 years ago and the original data no longer being retained. The journal issued an Expression of Concern to inform readers about these issues. [Extracted from the article]

A study published in the International Journal of Gynecology & Obstetrics examined the quality of mifepristone and misoprostol, two medications commonly used for medical abortions, in 11 countries. The study found that there were excess levels of impurities in both medications in eight of the countries. The impact of these impurities on safety and efficacy is not well understood. The study also identified a falsified version of the medication Cytotec®, which lacked any active ingredient. The presence of impurities in these medications could reduce their effectiveness and potentially cause harm to users. The study emphasizes the need for improved regulations and quality assurance standards for medical abortion medications to ensure the safety and efficacy of these drugs. [Extracted from the article]

Objective: To assess the cost-effectiveness of vaginal misoprostol (PGE1; 25 µg) compared with a slow-release dinoprostone (PGE2) pessary (10 µg) for labor induction due to an unfavorable cervix at term. Methods: We used data from an open-label multicenter, randomized non-inferiority trial that recruited women for whom labor was induced for medical reasons. The incremental cost-effectiveness ratio was assessed from the payer's perspective, with the focus on inpatient care costs and using the cesarean deliveries avoided (CDA) rate as the primary analysis and the rate of vaginal delivery within 24 h (VD24) as the secondary analysis. Results: Analyses were based on 790 women in each group. Differences between treatment arms were the mean cost per patient of €4410 and €4399, a CDA rate of 80.1% and 77.9% and a VD24 rate of 46.1% and 59.4% for dinoprostone and misoprostol, respectively. Dinoprostone is not cost-effective according to the CDA rate and misoprostol was either a cost-effective or a dominant strategy according to the VD24. Conclusion: Misoprostol and dinoprostone have equal cost management with mixed efficacy according to the clinical outcome used. Finally, misoprostol may be an attractive option for hospitals as the price is lower and it is easier to use. [ABSTRACT FROM AUTHOR]

Objective: To compare between 200 and 800 µg of vaginal misoprostol for cervical ripening before operative hysteroscopy. Methods: Quadruple- blind randomized clinical trial conducted between November 2019 and September 2020 involving 76 patients undergoing cervical dilatation before surgical hysteroscopy at teaching hospitals in Pernambuco, Brazil. Women received the vaginal misoprostol dosage of 200 or 800 µg,10-12 h before operative hysteroscopy. The cervical width was the primary outcome, and secondary outcomes were patient satisfaction, adverse effects, surgical complications, and duration of cervical dilatation. Chi-square tests of association, Fisher's exact and Mann-Whitney U tests were used with an α error of <5%. Results: There was no statistical difference between the groups in the mean of the cervical width (800 μg: 6.5 ± 1.6 mm vs 200 μg: 5.8 ± 1.8 mm, P = 0.055), patient satisfaction, and surgical findings, but the duration of cervical dilatation was lower in the 800- μg group (28.16 ± 28.5 s vs 41.97 ± 31.0 s, P = 0.035). Among the adverse effects, diarrhea was more frequent in the 800- μg group with statistical difference (100% vs 0%; P = 0.01). Conclusion: For cervical ripening, 200 μg misoprostol is equally effective with fewer adverse effects than 800 μg before operative hysteroscopy. ClinicalTrials.gov: NCT04152317. https://clini caltr ials.gov/ct2/show/NCT04 152317. [ABSTRACT FROM AUTHOR]

Objective: To illustrate the predictive value of peripheral blood α1-acid glycoprotein (AAG) in abortion outcomes with mifepristone and the relativity of concentration. Methods: A total of 134 patients who met the criteria were enrolled. The AAG and mifepristone concentrations were determined, and Student's t-test was used to assess significant differences in the levels of AAG between the complete and incomplete abortion groups. Results: The decrease in AAG concentration was associated with incomplete abortion, whereas the increase in AAG concentration was related to complete abortion (P < 0.01). In addition, the concentration of AAG was correlated with the concentration of mifepristone (r = 0.7375, P < 0.001). Conclusion: Our preliminary results suggest that AAG may serve as a biomarker for the prediction of incomplete abortions. [ABSTRACT FROM AUTHOR]

Objective: To examine the simultaneous effect of high-volume Foley catheter (HVFC) (60 ml) and vaginal misoprostol on labor induction in nulliparous women. Methods: A randomized, double- blind, controlled trial was conducted among nulliparous post-date (>40 weeks) pregnant women between June and December 2019. At enrollment 100 women were randomized into each group (either HVFC and vaginal misoprostol or low-volume Foley catheter [LVFC] [30 ml] and vaginal misoprostol), for labor induction. Demographic and clinical data were collected at enrollment and delivery. Results: Women in the HVFC group had statistically significantly shorter induction to delivery interval (median 860 min, interquartile range [IQR] 840-940 min vs. 1160 min, IQR 1080-1320 min, P < 0.001) and duration of labor (median 615 min, IQR 600-680 min vs. 750, IQR 692.5-800 min, P < 0.001). Mode of vaginal delivery (n = 94 vs. n = 78, P = 0.002), number of doses of misoprostol required (median 2, IQR 1-2 vs. 2, IQR 1-3), and need of oxytocin augmentation (n = 22 vs. n = 39, P = 0.014 and P < 0.001), was significantly better in the HVFC group. However, there was no significant difference with respect to other maternal or neonatal outcomes. Conclusion: Simultaneous use of HVFC and vaginal misoprostol for labor induction significantly shortens the induction to delivery interval and duration of labor in nulliparous women. Trial Registration: Clinical Trial Registry of India CTRI/2019/05/019394 (http://ctri. nic.in/Clini caltr ials/pmain det2.php?trial id=31554 &EncHi d=&userN ame=Foley %20cat heter). [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness and safety of repeat misoprostol versus expectant management in women with first‐trimester incomplete miscarriage who have been initially treated with misoprostol. Methods: The study was an open‐labeled randomized controlled trial including women with an incomplete first‐trimester miscarriage after administration of misoprostol. The participants were randomly assigned to vaginal misoprostol or expectant management using a computer‐generated table of random numbers. The primary outcome was the number of women with a complete miscarriage at 1 week. Results: Eighty‐eight women (44 women in each group) were analyzed. The rate of complete miscarriage at 1 week was significantly higher in the misoprostol group than the expectant management group—29 (69.0%) versus 7 (16.7%) (P < 0.001), respectively. Women in the misoprostol group were more satisfied (7.00 ± 0.77 vs 4.57 ± 1.61, P < 0.001) but reported more pain (7.95 ± 1.85 vs 5.26 ± 1.08, P < 0.001) than women in the expectant group. The misoprostol group reported more adverse effects than the expectant management group (P < 0.001). Conclusion: In women with an incomplete first‐trimester miscarriage who were initially treated with misoprostol, repeat administration of misoprostol was more effective than expectant management for achieving complete miscarriage at 1 week. However, misoprostol was associated with more adverse effects. Registration site and number: Clinicaltrials.gov: NCT03148561. Synopsis: Misoprostol treatment is more effective than expectant management in achieving complete miscarriage for women with an incomplete first‐trimester miscarriage initially treated by misoprostol. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy and safety of the hourly administration of titrated oral misoprostol solution (OMS) and vaginal dinoprostone for induction of labor. Methods: Titrated OMS was administrated hourly for induction of labor, starting with a dose of 20 µg and terminating at a dose of 50 µg. The safety and efficacy of OMS were compared with that of vaginal dinoprostone for induction of labor. Results: From June 2016 to October 2019, 2280 (78.3%) and 2115 (72.9%) women who received titrated OMS and vaginal dinoprostone, respectively, had a vaginal delivery (P = 0.005). Cesarean delivery was performed in 632 (21.7%) and 783 (27.0%) women who received titrated OMS and vaginal dinoprostone, respectively (P = 0.008). Tachysystole with changes in fetal heart rate (FHR) was seen in 104 (3.6%) and 249 (8.6%) women in the OMS and dinoprostone groups, respectively (P = 0.007). The frequency of non‐reassuring FHR was lower in the OMS group compared to the dinoprostone group (P = 0.006). Conclusion: The titrated OMS has an efficacy comparable to vaginal dinoprostone. Moreover, it causes a lower incidence of cesarean delivery, lower frequency of tachysystole with changes in FHR, and non‐reassuring FHR. Synopsis: Titrated oral misoprostol has a similar efficacy to dinoprostone, but with a lower incidence of cesarean delivery and lower frequency of non‐reassuring fetal heart rate. [ABSTRACT FROM AUTHOR]

Objective: To compare 1‐ and 2‐day drug administration interval between mifepristone and misoprostol for second‐trimester pregnancy termination and provide evidence‐based recommendations. Methods: Search strategy: the search was performed in Pubmed, EMBASE, and Cochrane Library for the relevant published studies from their establishment to March 2020. Selection criteria: randomized controlled trials (RCTs) comparing 1‐ and 2‐day time interval of mifepristone‐misoprostol for termination of pregnancy during second‐trimester pregnancy were considered. Data were processed using Revman 5.3 software. Results: Meta‐analyses of three RCTs showed no significant difference was reported in the induction‐to‐abortion time and successful abortion rate between 1‐ and 2‐day mifepristone and misoprostol intervals. Statistical difference was not identified in the induction‐to‐abortion time between the two drug administration intervals in nulliparous or parous women. Conclusions: Both 1‐ and 2‐day dosing intervals between mifepristone and misoprostol are suitable for clinical use for second‐trimester medical termination of pregnancy. Synopsis: This study compared 1‐ and 2‐day administration interval between mifepristone and misoprostol for mid‐trimester pregnancy termination and indicated that both dosing intervals are suitable. [ABSTRACT FROM AUTHOR]

Retraction: Ali, M. K., Eman, S. M., Abdel‐Aleem, M. A., Sobh, A. M. A. Misoprostol versus expectant management in women with incomplete first‐trimester miscarriage after failed primary misoprostol treatment: A randomized clinical trial. International Journal of Gynecology & Obstetrics, 154: 558–564. https://doi.org/10.1002/ijgo.13652. The above article, published online on 22 February 2021 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor‐in‐Chief, Professor Michael Geary, the International Federation of Gynecology and Obstetrics, and John Wiley and Sons Ltd. Concerns were raised by a third party about inconsistencies in the data and study design of this article and the authors were asked to provide an explanation. Following the authors' response, an independent review concluded that there were inconsistencies in the sample sizes reported in the manuscript, and between the manuscript and the trial registry. There was also a change in the primary outcome in the trial registry that was not reported in the manuscript. Therefore, the parties agreed that the article must be retracted. The authors were notified about the retraction but did not respond. [ABSTRACT FROM AUTHOR]

A letter to the editor discusses the findings of a study on the quality of abortion drugs, mifepristone and misoprostol, in 11 countries. The study reveals that these drugs have low quality in lower- and middle-income countries (LMICs), which raises concerns about safety and efficacy. The article emphasizes the need for further research to understand the implications of these quality issues, such as unknown side effects and increased complications. It also highlights the importance of regulating medical abortion drugs in LMICs to ensure that women have access to high-quality and safe drugs. [Extracted from the article]

Objective: To determine the factors associated with delayed onset of active labor following labor induction with vaginal misoprostol. Methods: We conducted a prospective cohort study over 6 months at a tertiary hospital in Uganda. We enrolled mothers with pregnancies of at least 28 weeks, who were undergoing labor induction with 50 µg of vaginal misoprostol, administered every 6 hours with a maximum of four doses, and followed them up until onset of active labor. Labor onset was considered delayed if it occurred later than 12 hours after the first dose. Bivariate and multivariate analysis was performed to determine factors associated with delayed onset of active labor. Results: Of the 88 mothers enrolled, 22.7% (n=20) had delayed onset of active labor. Nulliparity (adjusted relative risk [aRR] 2.34, 95% confidence interval [CI] 1.17–4.68) and gestational age less than 37 weeks (aRR 3.79, 95% CI 1.40–10.23) were associated with delayed onset of active labor following vaginal misoprostol administration whereas higher body mass index (aRR 0.38, 95% CI 0.18–0.79) decreased the risk. Conclusion: Delayed onset of active labor following labor induction remains an important obstetric care challenge. Mothers undergoing labor induction should have their body mass index documented, and nulliparous women and mothers at less than 37 weeks of gestation should have their labor monitored for a longer duration following labor induction. Synopsis: Nulliparity and gestational age less than 37weeks are associated with delayed onset of active labor following labor induction with vaginal misoprostol. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy and safety of rectal misoprostol with intrauterine misoprostol in the reduction of blood loss during and after cesarean delivery. Methods: Ninety‐eight pregnant women, all candidates for elective cesarean delivery, were equally randomized into two groups: the rectal group (received preoperative misoprostol rectally) and the intrauterine group (received intrauterine misoprostol after the delivery of the placenta). The primary outcome was the estimated blood loss (EBL) during cesarean delivery. Secondary outcomes included the occurrence of excessive blood loss (>1000 mL) within the first 24 hours postoperatively and the occurrence of any maternal or fetal side effects. Results: There were no statistically significant differences between the two groups regarding either the EBL (693.12 ± 139.09 vs 692.39 ± 132.83; P=0.979) or the occurrence of postpartum hemorrhage (>1000 mL) (6.1% vs 4.1%; P=0.99. Apgar scores at 1 and 5 minutes were significantly higher in the intrauterine group compared to the rectal group. Conclusion: Insertion of intrauterine misoprostol is as effective as rectal insertion in reducing blood loss during and after cesarean delivery; however, it has a safer neonatal outcome and is more convenient when administered during cesarean delivery. ClinicalTrials.gov: NCT03723031. Intrauterine insertion of misoprostol is safer, more convenient, and as effective as rectal insertion in reducing blood loss during and after cesarean delivery. [ABSTRACT FROM AUTHOR]

Objective: To determine whether addition of letrozole to a misoprostol‐based abortion regimen can increase the rate of complete abortion. Methods: The randomized, placebo‐controlled, double‐blind trial enrolled women with missed abortion in the first trimester of pregnancy attending Sadooghi Hospital, Isfahan, Iran, from 2016 to 2018. The women were randomly assigned to the study group, which received 10 mg of letrozole daily for 3 days, followed by two doses of 800 μg of vaginal misoprostol at a 4‐hour interval, or the control group, which received a placebo, followed by the same dose of misoprostol. Sonography was performed to check the abortion status. Results: In total, 120 women completed the study: 60 in the misoprostol plus letrozole group, and 60 in the misoprostol only group. Complete abortion was documented for 93 (77.5%) women: 48 (80.0%) in the misoprostol plus letrozole group and 45 (75.0%) in the misoprostol only group (P=0.80). The mean duration of induction in the misoprostol plus letrozole and misoprostol only groups was 7.35 ± 3.54 hours and 8.2 ± 3.8 4hours, respectively (P=0.21). Conclusion: Administration of misoprostol alone was found to be as effective as the administration of misoprostol plus letrozole for first‐trimester missed abortion. As compared with misoprostol alone, letrozole plus misoprostol did not increase the rate of complete abortion for pregnant women with first‐trimester missed abortion. [ABSTRACT FROM AUTHOR]

Objective: To explore the strategies undertaken to decentralize menstrual regulation services and implement task-sharing, including barriers and facilitators, with nonphysician providers in Bangladesh.Methods: We conducted a desk review of relevant policies and health service information from grey and published literature on task-sharing in menstrual regulation services, plus stakeholder interviews with 19 representatives of relevant health organizations to investigate facilitators for and barriers to the implementation of task-sharing of these services.Results: Task-sharing in menstrual regulation began in 1979 as part of the national family planning program. The Ministry of Health and Family Welfare has guidelines for menstrual regulation services provided by a wide range of healthcare workers using manual vacuum aspiration and the medications misoprostol and mifepristone. Despite government approval, implementation of task-sharing is challenging owing to lack of skilled providers, lack of facility readiness, and unmet need for family planning.Conclusion: The government needs to implement effective planning for skills building of nonphysician providers and ensuring facility readiness for provision of menstrual regulation services to reduce unsafe abortion in Bangladesh. [ABSTRACT FROM AUTHOR]

Objective: To compare effectiveness and safety of carbetocin and misoprostol for prevention of postpartum hemorrhage (PPH) among low-risk women.Methods: Randomized controlled trial among 150 pregnant women with low risk of PPH admitted for vaginal delivery at Kasr Al Ainy Hospital, Cairo, Egypt, between July 2018 and May 2019. Participants were assigned to two groups by a web-based randomization system ensuring allocation concealment. After neonatal delivery, the carbetocin group received one ampoule of carbetocin (100 μg/mL) intravenously and the misoprostol group received two rectal tablets of misoprostol (800 μg) for active management of the third stage. Blood pressure, blood loss, and hemoglobin levels were monitored. The primary outcome measure was need for additional uterotonic drugs.Results: The carbetocin group had significantly less blood loss (P<0.001), shorter third stage (P<0.001), and less need for additional uterotonics (P=0.013) or uterine massage (P=0.007). The two drugs were hemodynamically safe. Hemoglobin levels after delivery were comparable in the two groups (P=0.475). Adverse effects were more common in the misoprostol group (P<0.001).Conclusion: Among low-risk women, carbetocin seems to be a better alternative to misoprostol for active management of the third stage of labor; it reduced blood loss and use of additional uterotonic drugs. CLINICALTRIALS.GOV: NCT03556852. [ABSTRACT FROM AUTHOR]

Background: Optimal dose, interval, and administration route of misoprostol with added benefit of mifepristone for management of second trimester intrauterine fetal death (IUFD) are not established.Objectives: To assess effectiveness, safety, and acceptability of medical management of second trimester IUFD.Search Strategy: Research databases from January 2006 to October 2018.Selection Criteria: Randomized controlled trials with IUFD cases at 14-28 weeks of gestation.Data Collection and Analysis: We screened and extracted data, assessed risk of bias, conducted analyses, and assessed overall certainty of the evidence.Main Results: Sixteen trials from 1695 citations. When misoprostol is used alone, 400 μg is more effective than 200 μg (RR 0.78; 95% CI, 0.66-0.92, moderate certainty evidence); the sublingual route is more effective than the oral route (RR 0.88; 95% CI, 0.70-1.11, low certainty evidence). There may be little to no difference between the sublingual and vaginal route (RR 0.93; 95% CI, 0.85-1.03, low certainty evidence). Certainty of evidence related to mifepristone-misoprostol regimens and safety and acceptability is very low.Conclusions: Misoprostol 400 μg every 4 hours, sublingually or vaginally, may be effective. We cannot draw conclusions about safety and acceptability, or about the added benefits of mifepristone. [ABSTRACT FROM AUTHOR]

Objective: To assess the safety and efficacy of preoperative rectal misoprostol for the prevention of intraoperative and postoperative blood loss in women undergoing elective cesarean delivery.Methods: A single-blind randomized controlled trial of 200 full-term pregnant women scheduled for elective cesarean delivery. Computer-generated randomization allocated women to receive 400 μg rectal misoprostol at urinary catheter insertion plus 400 μg rectally after abdominal closure (preoperative group, n=100) or 800 μg of rectal misoprostol after abdominal closure (postoperative group, n=100). Primary outcome was intraoperative blood loss.Results: Intraoperative blood loss was significantly lower in the preoperative misoprostol group compared with the postoperative group (528.7 ± 114.8 mL vs 788.6 ± 165.8 mL; P<0.001). Blood loss during the first 24 hours after delivery was also lower in the preoperative group (199.3 ± 84.5 mL vs 302.9 ± 125.6 mL; P<0.001). Fewer women in the preoperative group needed additional uterotonics (7 vs 21; P<0.001). After delivery, the decrease in both hemoglobin and hematocrit levels was significantly less in the preoperative group (-6.8 vs -12.8% and -6.05 vs -17.8%, respectively; P<0.001).Conclusion: Preoperative rectal administration of misoprostol significantly reduced intraoperative and postoperative blood loss during and after elective cesarean delivery. ClinicalTrial.gov ID: NCT03680339. Date of registration 9/2018. [ABSTRACT FROM AUTHOR]

Objectives: To assess the severity of complications following misoprostol used to induce abortion compared with other methods among women admitted for postabortion complications. Methods: A cross‐sectional study of women who presented with complications of induced abortion at nine secondary and tertiary hospitals in South West Nigeria between April 1, 2013 and May 31, 2014. Face‐to‐face interviews were conducted and information on the current admission was extracted from patient records. Associations between abortion method used and severity of abortion complications were evaluated using χ2 and Fisher exact tests. Results: Of 522 women included in the study, 177 reported an induced abortion: 41 women (23.2%) had used misoprostol at the first attempt to induce abortion, whereas 79 (44.6%) women had undergone surgical abortion. Occurrence of fever (P=0.06), bleeding (P=0.3), and lower abdominal pain (P=0.32) was not significantly different between the misoprostol and surgical abortion/other methods groups. Severe complications were rare with misoprostol, but more common among women in the surgical abortion/other methods group. Maternal mortality occurred only among women in the surgical abortion/other methods group. Conclusion: Use of misoprostol for induced abortion was associated with fewer complications and no maternal mortality compared with surgical abortion/other methods. Use of misoprostol for induced abortion was associated with fewer complications and no maternal mortality compared with surgical abortion/other methods. [ABSTRACT FROM AUTHOR]

Background: Several uterotonic options exist for prevention of postpartum hemorrhage (PPH); hence, cost‐effectiveness is an important decision‐making criterion affecting uterotonic choice. Objective: To conduct a systematic review of cost‐effectiveness of uterotonics for PPH prevention to support a WHO guideline update. Search strategy: We searched major databases from 1980 to June 2018 and the National Health Services Economic Evaluation (NHS EED) database from inception (1995) to March 2015 for eligible studies. Selection criteria: We included comparative economic evaluations, cost‐utility analyses, and resource‐utilization studies. Data collection and analysis: Two reviewers independently assessed studies and extracted data organized by birth mode and setting. Main results: We included 15 studies across all income categories that compared misoprostol versus no uterotonic (five studies) or versus oxytocin (one study), carbetocin versus oxytocin (eight studies), and one study comparing numerous uterotonics. In specific low‐resource contexts, we found reasonably good evidence that misoprostol was cost‐effective compared with no uterotonic. In the context of cesarean delivery, carbetocin was more cost favorable than oxytocin but certainty of this evidence was low. Conclusions: Evidence on the cost‐effectiveness of various uterotonic agents was not generalizable. As the number of competing uterotonics increases, rigorous economic evaluations including contextual factors are needed. Evidence on the cost‐effectiveness of uterotonics for prevention of postpartum hemorrhage was rarely generalizable beyond settings of individual studies and lacked considerations of contextual factors. [ABSTRACT FROM AUTHOR]

This paper analyses an important set of legal issues raised by the telemedical provision of abortion pills. Focusing on the case of European Union (EU) law, it suggests that a properly accredited doctor seeking to treat a patient with abortion pills is entitled, in principle, to rely on EU rules of free movement to protect their access to patients in other member states, and women facing unwanted pregnancies likewise have legal rights to access the services thus offered. EU countries seeking to claim an exception to those rules on the basis of public health or the protection of a fundamental public policy interest (here, the protection of fetal life) will face significant barriers. [ABSTRACT FROM AUTHOR]

Objective: To explore the clinical and programmatic feasibility of using 800 μg of sublingual misoprostol to prevent and treat postpartum hemorrhage (PPH) during home delivery.Methods: The present double-blind randomized controlled trial included women who underwent home deliveries in Chitral district, Khyber Pakhtunkhwa province, Pakistan, after presenting at healthcare facilities during the third trimester of pregnancy between May 28, 2012, and November 27, 2014. Participants were randomized in a 1:1 ratio to receive either 800 μg of misoprostol or placebo sublingually if PPH was diagnosed, having previously received a prophylactic oral dose of 600 μg misoprostol. The primary outcome, hemoglobin decrease of 20 g/L or greater from pre- to post-delivery assessment, was compared on a modified intention-to-treat basis.Results: There were 49 patients allocated to receive misoprostol and 38 allocated to receive placebo; the incidence of a 20 g/L decrease in hemoglobin was similar between the groups (20/43 [47%] vs 19/33 [58%], respectively; P=0.335).Conclusion: There was no significant difference in clinical outcomes between the two trial arms. ClinicalTrials.gov:NCT01485562. [ABSTRACT FROM AUTHOR]

Objective: To assess misoprostol availability at community pharmacies and determine factors affecting misoprostol prescription for medical abortion.Methods: A cross-sectional quantitative survey of randomly sampled community pharmacies and their corresponding pharmacists/pharmacy workers was conducted in the city of Accra, Ghana. Structured questionnaires were administered to collect data between May 1 and July 28, 2016. Descriptive statistics (frequencies and proportions) and bivariate and logistic regression analysis were used to analyze the data.Results: Of the 165 community pharmacies surveyed, approximately half (83 [50.3%]) stocked misoprostol. Availability of misoprostol however decreased when moving from first class to third class residential areas. 44 (26.7%) of the respondents had prescribed the drug at some time for medical abortion, but 140 (84.6%) indicated they would not prescribe the drug for medical abortion in future. Factors that significantly predicted misoprostol prescription for medical abortion included sex of the pharmacist/pharmacy worker, demand, and availability of misoprostol.Conclusions: Demand for misoprostol for medical abortion was found to be high but only half of community pharmacies stocked it, and most pharmacy workers did not wish to prescribe the drug. If community pharmacies are to effectively contribute to expanding access to safe abortion services in Ghana, the disparity between misoprostol provision and demand needs to be addressed. [ABSTRACT FROM AUTHOR]

Objective: To establish whether national guidelines for postpartum hemorrhage (PPH) reflect new scientific evidence on misoprostol, and determine the challenges faced in their implementation.Methods: A web-based survey was sent by email to 130 national societies of obstetrics and gynecology (FIGO Member Associations) in 2016. The survey, composed of 18 questions, covered national guidelines on PPH with particular reference to misoprostol, the creation of national guidelines, and challenges to implementation.Results: Completed surveys were received from 69 societies, for a 53% response rate. The key findings were that many countries lacked comprehensive, up-to-date, evidence-based national guidelines providing guidance on misoprostol use; recommended regimens were very different in the national guidelines as well as between international and regional guidelines that are most often used as referencing documents; and there are a variety of challenges to implementation of guidelines.Conclusion: There is a need, especially in countries with high maternal mortality, to establish mechanisms that ensure the existence of up-to-date, comprehensive, evidence-based guidelines on PPH. This can be difficult given conflicting guidance at the international level. Regional and international societies should prioritize clinical updates and ensure their dissemination and implementation. [ABSTRACT FROM AUTHOR]

Objective: To assess the feasibility of using an at-home multilevel pregnancy test (MLPT) and interactive voice response (IVR) call-in system for remote follow-up of medical abortion.Methods: A prospective pilot study was conducted among women who had a medical abortion at up to 70 days at a clinic in Mexico City, Mexico, between June 1, 2015, and January 30, 2016. Participants took an MLPT at the initial clinic visit and another MLPT at home 2 weeks later. They were requested to report their MLPT results via the IVR system and attend the clinic for follow-up evaluation.Results: Of 200 women considered for inclusion, 163 (81.5%) were included in the analysis. Only 10 (6.6%) of the 152 women who had a medical abortion on or before 63 days from last menstrual period reported MLPT results to the IVR system that required clinical evaluation to assess medical abortion outcome. The remaining 142 (93.4%) women in this group reported MLPT results that ruled out ongoing pregnancy (confirmed at clinical evaluation). Reported MLPT results ruled out ongoing pregnancy among the 11 women who had a medical abortion after 63 days; however, 1 (9%) had an ongoing pregnancy at clinical evaluation.Conclusion: Use of MLPTs and the IVR system provided a streamlined approach to follow-up after medical abortion. [ABSTRACT FROM AUTHOR]

Synopsis: The present study details MSI's mechanisms for determining abortifacient quality. These can be applied more widely to other key SRH and ancillary medicines. [ABSTRACT FROM AUTHOR]

Background: Medical management of retained placenta could be a safe alternative to manual removal.Objective: To evaluate the efficacy of prostaglandin analogues for retained placenta.Search Strategy: MEDLINE, EMBASE, CENTRAL, ICTRP, LILACS, and OpenSIGLE were searched without language restrictions from inception to January 31, 2017, by combining terms for retained placenta and prostaglandin analogues.Selection Criteria: Randomized controlled trials comparing prostaglandin analogues with any other intervention.Data Collection and Analysis: Trials were independently assessed for inclusion, data extraction, and risk of bias. Data were extracted for meta-analyses. GRADE was used to evaluate the quality of data.Main Results: Seven randomized controlled trials (851 patients) were included. Prostaglandins did not increase the placenta expulsion rate (relative risk [RR] 1.40, 95% confidence interval [CI] 0.83-2.36) or decrease maternal transfusion (RR 0.72, 95% CI 0.43-1.22). In comparison with oxytocin, prostaglandins did not modify the expulsion rate (RR 1.26, 95% CI 0.90-1.78), maternal transfusion (RR 1.05, 95% CI 0.27-4.09), or time for delivery of placenta (mean difference -1.56 minutes, 95% CI, -9.25-6.13). Three trials comparing prostaglandins with oxytocin agonists, ergometrine, and manual removal reported similar results.Conclusions: Prostaglandin analogues do not offer an effective alternative for management of retained placenta. [ABSTRACT FROM AUTHOR]

Objective: To examine the use of mifepristone and misoprostol for menstrual regulation among Bangladeshi women attending public sector facilities.Methods: In a prospective study, women (aged ≥18 years) with up to 9 weeks of amenorrhea were enrolled at 24 government health facilities in Bangladesh from November 2012 to June 2015. Paramedics or female welfare visitors provided most menstrual regulation care. Participants took 200 mg mifepristone followed by 800 μg buccal misoprostol after 24 hours, and were asked to return to the clinic 10-14 days later for clinical assessment and an exit interview. The primary outcome was successful evacuation of the uterus without need for surgical intervention. Women who completed follow-up were included in analyses for the primary outcome.Results: Among 1744 enrolled participants, 1738 completed follow-up. Most (1674, 96.3%) had a successful uterine evacuation without the need for surgical intervention. A successful outcome was significantly more common in primary (724/744, 97.3%) and secondary facilities (861/895, 96.2%) than in the specialty hospital (89/99, 89.9%; P<0.001 and P=0.004, respectively).Conclusion: Menstrual regulation with mifepristone and misoprostol can be provided effectively in public sector facilities in Bangladesh. CLINICALTRIALS.GOV: NCT01798017. [ABSTRACT FROM AUTHOR]

Objective: To determine the proportion of women presenting for an induced abortion in Ghana who could use a gestational wheel to determine if they had reached at least 13 weeks or fewer than 13 weeks of pregnancy accurately.Methods: The present cross-sectional study was conducted at four facilities in Ghana between February 1, and July 31, 2014. Women aged at least 18 years seeking induced abortions who had not previously been informed of the length of their pregnancy by a clinician were enrolled. Women self-assessed pregnancy duration using a gestational wheel before a clinician assessed the length via clinical assessment and bimanual exam for use as a respective reference point. The proportion of participants who used the wheel successfully was calculated.Results: The study enrolled 780 participants, 770 of whom used the gestational wheel. Of these, 221 (28.7%) could use the wheel without verbal instructions, and 465 (60.4%) described it as easy to use. Agreement in pregnancy-length assessments was recorded for 728 (94.5%) patients. There were 10 (1.3%) and 28 (3.6%) participants who made evaluations with "low-risk disagreement" and "high-risk disagreement" with the clinician assessment, respectively.Conclusion: Almost all participants could use the gestational wheel to date their pregnancies correctly. This tool could help women perform medical abortions safely in the community, reducing morbidity and mortality from unsafe abortions. [ABSTRACT FROM AUTHOR]