Search

The US Food and Drug Administration–approved segesterone acetate and ethinyl estradiol ring-shaped contraceptive vaginal system, known as Annovera (Sever Pharma Solutions/QPharma, Malmö, Sweden), was inserted and removed under a woman's control for a 21 day in and 7 day out regimen for up to 13 cycles of use. We aimed to describe the patterns of ring expulsion over time, to identify potential predictors of expulsion, and to evaluate the impact of expulsions on method discontinuation and pregnancy risk. Using data from 2064 participants who were enrolled in 2 multinational phase 3 clinical trials on the use of this contraceptive vaginal system, we examined data from participants' daily diaries for documentation of complete ring expulsion. We modeled the odds of reported expulsions over time with adjustment for background and demographic characteristics using mixed-effects logistic regression models with random intercepts. We compared the probability of continuation between those who did and those who did not report expulsions in the first cycle of use using survival analysis and hazards modeling. To determine if expulsions during the first cycle of use affected the risk for pregnancy, we calculated Pearl Indices. Most participants (75%) never experienced any expulsions during any cycle of use, and 91% to 97% did not experience an expulsion during any 1 cycle. The incidence of expulsion was highest in cycle 1 (9%). The odds of experiencing expulsions decreased by half in cycles 2 to 8 when compared with cycle 1 (0.48; 95% confidence interval, 0.40–0.58), and in cycles 9 to 13, expulsions were about a third of that in cycle 1 (0.32; 95% confidence interval, 0.26–0.41). Of those who did experience expulsions, most (62%–84%) experienced ≤2 expulsions per cycle. Participants from study sites in Latin America vs those in the United States had higher odds of not experiencing an expulsion (odds ratio, 1.95; 95% confidence interval, 1.45–2.63). Women with a higher education level had higher odds of experiencing an expulsion. Notably, parity, age, and body mass index were not associated with expulsion. Participants who experienced any expulsions in cycle 1 were more likely to discontinue use early (hazard ratio, 1.28; 95% confidence interval, 1.14–1.43) than participants who did not have an expulsion. The Pearl Index for participants who had expulsions during cycle 1 was 3.99 (95% confidence interval, 1.29–9.31), which was higher than that among participants who reported no expulsions (Pearl Index, 2.39; 95% confidence interval, 1.61–3.41), but the overlapping confidence intervals indicate that there is not sufficient evidence to demonstrate an association between expulsions and pregnancy risk. Expulsions were infrequent overall, decreased with subsequent cycles of use, and were not associated with body mass index or parity. Early discontinuation of product use was higher among participants who experienced an expulsion during cycle 1. Although it is unclear whether pregnancy risk was associated with expulsions, early recognition of expulsions among users may identify those at higher risk for discontinuation and may highlight when enhanced anticipatory counselling and guidance may be advantageous. [ABSTRACT FROM AUTHOR]

Objective: To assess if there is a relationship between use of combined antiretroviral therapy among pregnant women living with HIV and hypertensive disorders of pregnancy (HDP).Design: Due to the heterogeneity of study designs in the literature and the utilization of different outcome measures in regards to assessing the presence of HDP, a systematic review was performed.Methods: ClinicalTrials.gov and MEDLINE, via PubMed, EMBASE, Scopus, CINAHL, ProQuest Dissertations & Theses Global, EBSCOHost, DARE, and the Cochrane Library, were queried from January 1997 to October 2017. Studies were included if they reported HDP and focused on pregnant women living with HIV who used combined antiretroviral therapy. The Cochrane Collaboration's tool for assessment of risk of bias and the U.S. Preventive Services Task Force grading scale were used to assess the studies.Results: Of 1055 abstracts, 28 articles met inclusion criteria. The data are marked by multiple biases and poor study design. All studies demonstrate an increased risk of HDP among pregnant women living with HIV who used combined antiretroviral therapy when compared to seropositive pregnant women not using antiretroviral therapy. Three studies suggest protease inhibitors may be associated with a higher risk of HDP.Conclusion: Despite all studies indicating a higher frequency of HDP among pregnant women living with HIV using combined antiretroviral therapy when compared with seropositive pregnant women not using antiretroviral therapy, the quality of the studies is mixed, necessitating further research. [ABSTRACT FROM AUTHOR]

Background: Understanding associations between pregnancy and HIV disease progression is critical to provide appropriate counseling and care to HIV-positive women.Methods: From 2006 to 2011, women less than age 40 with incident HIV infection were enrolled in an early HIV infection cohort in Kenya, Rwanda, South Africa, Uganda, and Zambia. Time-dependent Cox models evaluated associations between pregnancy and HIV disease progression. Clinical progression was defined as a single CD4 measurement <200 cells/μl, percent CD4 <14%, or category C event, with censoring at antiretroviral (ART) initiation for reasons other than prevention of mother-to-child transmission (PMTCT). Immunologic progression was defined as two consecutive CD4s ≤350 cells/μl or a single CD4 ≤350 cells/μl followed by non-PMTCT ART initiation. Generalized estimating equations assessed changes in CD4 before and after pregnancy.Results: Among 222 women, 63 experienced clinical progression during 783.5 person-years at risk (8.0/100). Among 205 women, 87 experienced immunologic progression during 680.1 person-years at risk (12.8/100). The association between pregnancy and clinical progression was adjusted hazard ratio [aHR] = 0.7; 95% confidence interval (CI): 0.2, 1.8. The association between pregnancy and immunologic progression was aHR = 1.7; 95% CI: 0.9, 3.3. Models controlled for age; human leukocyte antigen alleles A*03:01, B*45, B*57; CD4 set point; and HIV-1 subtype. CD4 measurements before versus after pregnancies were not different.Conclusions: In this cohort, pregnancy was not associated with increased clinical or immunologic HIV progression. Similarly, we did not observe meaningful deleterious associations of pregnancy with CD4s. Our findings suggest that HIV-positive women may become pregnant without harmful health effects occurring during the pregnancy. Evaluation of longer-term impact of pregnancy on progression is warranted. [ABSTRACT FROM AUTHOR]

Copyright of African Journal of Reproductive Health is the property of Women's Health & Action Research Centre and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Pain management approaches during uterine aspiration vary, which include local anesthetic, oral analgesics, moderate sedation, deep sedation, or a combination of approaches. For local anesthetic approaches specifically, we continue to have suboptimal pain control. Gabapentin as an adjunct to pain management has proven to be beneficial in gynecologic surgery. We sought to evaluate the impact of gabapentin on perioperative pain during surgical management of first-trimester abortion or early pregnancy loss with uterine aspiration under local anesthesia.Objective: We hypothesized that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with uterine aspiration. Secondary outcomes included tolerability of gabapentin and postoperative pain, nausea, vomiting, and anxiety.Study Design: We conducted a randomized double-blinded placebo-controlled trial of gabapentin 600 mg given 1 to 2 hours preoperatively among subjects receiving a first-trimester uterine aspiration under paracervical block in an outpatient ambulatory surgery center. There were 111 subjects randomized. The primary outcome was pain at time of uterine aspiration as measured on a 100-mm visual analog scale. Secondary outcomes included pain at other perioperative time points. To assess changes in pain measures, an intention to treat mixed effects model was fit with treatment groups (gabapentin vs control) as a between-subjects factor and time point as a within-subjects factor plus their interaction term. Because of a non-normal distribution of pain scores, the area under the curve was calculated for secondary outcomes with comparison of groups utilizing Mann-Whitney U tests.Results: Among the 111 randomized, most subjects were Black or African American (69.4%), mean age was 26 years (±5.5), and mean gestational age was 61.3 days (standard deviation, 14.10). Mean pain scores at time of uterine aspiration were 66.77 (gabapentin) vs 71.06 (placebo), with a mean difference of -3.38 (P=.51). There were no significant changes in pain score preoperatively or intraoperatively. Subjects who received gabapentin had significantly lower levels of pain at 10 minutes after surgery (mean difference [standard error (SE)]=-13.0 [-5.0]; P=.01) and 30 minutes after surgery (mean difference [SE]=-10.8 [-5.1]; P=.03) compared with subjects who received placebo. Median nausea scores and incidence of emesis pre- and postoperatively did not differ between groups. Similarly, anxiety scores did not differ between groups, before or after the procedure. At 10 and 30 minutes after the procedure, most participants reported no side effects or mild side effects, and this did not differ between groups.Conclusion: Preoperative gabapentin did not reduce pain during uterine aspiration. However, it did reduce postoperative pain, which may prove to be a desired attribute of its use, particularly in cases where postoperative pain may be a greater challenge. [ABSTRACT FROM AUTHOR]

Background: Integrating family planning interventions with HIV studies in developing countries has been shown to prevent mother-to-child HIV transmission and simultaneously reduce HIV and unintended pregnancy in high-risk populations. As part of a prospective cohort study on HIV incidence and risk factors in Zambian women having unprotected sex, we also offered family planning counseling and immediate access to long-acting reversible contraceptives. Although long-acting reversible contraceptives are the most effective form of contraception, many Zambian women are limited to oral or injectable methods because of a lack of knowledge or method availability. This project offers to single mothers who are enrolled in a cohort study information about and access to long-acting reversible contraceptives at enrollment and at each follow-up visit.Objective: This study evaluates how fertility intentions affect long-acting reversible contraceptive use in HIV-negative single mothers in Zambia. Our primary outcome was long-acting reversible contraceptive use throughout the study participation. We also estimated rates of long-acting reversible contraceptive uptake and discontinuation. We specifically studied single mothers because they are at high risk for unintended pregnancy, which can have significant negative ramifications on their financial, social, and psychologic circumstances.Study Design: From 2012-2017, Zambia Emory HIV Research Project recruited 521 HIV-negative single mothers ages 18-45 years from government clinics in Lusaka and Ndola, Zambia's 2 largest cities. Participants were followed every 3 months for up to 5 years. At each visit, we discussed fertility goals and contraceptive options and offered a long-acting reversible method to any woman who was not pregnant or who already was using a long-acting reversible or permanent contraceptive method. Data were collected on demographic factors, sexual behavior, and reproductive history. Multivariable logistic regression was used to model baseline fertility intentions with long-acting reversible contraceptive use.Results: We enrolled 518 women; 57 women did not return for any follow-up visits. There was a significant increase in long-acting reversible contraceptive use during the study. At baseline, 93 of 518 women (18%) were using a long-acting reversible method, and 151 of 461 women (33%) used a long-acting reversible method at the end of follow-up period (P<.0001). Four women chose an intrauterine device, and 91 women chose an implant for their first uptake event. After we adjusted the data for other confounders, we found that women in Ndola who did not desire any more children were more likely to use a long-acting reversible contraceptive (adjusted prevalence ratio, 2.02; 95% confidence interval, 1.88-3.42). During follow up, 37 of 183 long-acting reversible contraceptive users (20%) discontinued their method; women who desired future children at baseline were more likely to discontinue earlier (P=.016).Conclusion: This study demonstrates that integrated family planning services can increase long-acting reversible contraceptive use successfully among Zambian single mothers, who are a vulnerable population that disproportionately is affected by unintended pregnancy. A steady increase in use over time confirms the importance of repeated messaging about these unfamiliar methods. Thus, it is imperative that family planning interventions target single mothers in developing countries to promote effective contraceptive use. [ABSTRACT FROM AUTHOR]

Background: Relatively little is known about the frequency and factors associated with miscarriage among women living with HIV.Objective: The objective of the study was to evaluate factors associated with miscarriage among women enrolled in the Women's Interagency HIV Study.Study Design: We conducted an analysis of longitudinal data collected from Oct. 1, 1994, to Sept. 30, 2017. Women who attended at least 2 Women's Interagency HIV Study visits and reported pregnancy during follow-up were included. Miscarriage was defined as spontaneous loss of pregnancy before 20 weeks of gestation based on self-report assessed at biannual visits. We modeled the association between demographic, behavioral, and clinical covariates and miscarriage (vs live birth) for women overall and stratified by HIV status using mixed-model logistic regression.Results: Similar proportions of women living with and without HIV experienced miscarriage (37% and 39%, respectively, P = .638). In adjusted analyses, smoking tobacco (adjusted odds ratio, 2.0), alcohol use (adjusted odds ratio, 4.0), and marijuana use (adjusted odds ratio, 2.0) were associated with miscarriage. Among women living with HIV, low HIV viral load (<4 log10 copies/mL) (adjusted odds ratio, 0.5) and protease inhibitor (adjusted odds ratio, 0.4) vs the nonuse of combination antiretroviral therapy use were protective against miscarriage.Conclusion: We did not find an increased odds of miscarriage among women living with HIV compared with uninfected women; however, poorly controlled HIV infection was associated with increased miscarriage risk. Higher miscarriage risk among women exposed to tobacco, alcohol, and marijuana highlight potentially modifiable behaviors. Given previous concern about antiretroviral therapy and adverse pregnancy outcomes, the novel protective association between protease inhibitors compared with non-combination antiretroviral therapy and miscarriage in this study is reassuring. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to determine whether interactions between non-rifamycin antibiotics and hormonal contraceptives result in decreased effectiveness or increased toxicity of either therapy.Study Design: We searched MEDLINE, Embase, clinicaltrials.gov, and Cochrane libraries from database inception through June 2016. We included trials, cohort, case-control, and pharmacokinetic studies in any language that addressed pregnancy rates, pharmacodynamics, or pharmacokinetic outcomes when any hormonal contraceptive and non-rifamycin antibiotic were administered together vs apart. Of 7291 original records that were identified, 29 met criteria for inclusion.Study Appraisal and Synthesis Methods: Two authors independently assessed study quality and risk of bias using the United States Preventive Services Task Force evidence grading system. Findings were tabulated by drug class.Results: Study quality ranged from good to poor and addressed only oral contraceptive pills, emergency contraception pills, and the combined vaginal ring. Two studies demonstrated no difference in pregnancy rates in women who used oral contraceptives with and without non-rifamycin antibiotics. No differences in ovulation suppression or breakthrough bleeding were observed in any study that combined hormonal contraceptives with any antibiotic. No significant decreases in any progestin pharmacokinetic parameter occurred during co-administration with any antibiotic. Ethinyl estradiol area under the curve decreased when administered with dirithromycin, but no other drug.Conclusion: Evidence from clinical and pharmacokinetic outcomes studies does not support the existence of drug interactions between hormonal contraception and non-rifamycin antibiotics. Data are limited by low quantity and quality for some drug classes. Most women can expect no reduction in hormonal contraceptive effect with the concurrent use of non-rifamycin antibiotics. [ABSTRACT FROM AUTHOR]

Background: There is limited information on the patterns and trends of contraceptive use among women living with HIV, compared with noninfected women in the United States. Further, little is known about whether antiretroviral therapy correlates with contraceptive use. Such information is needed to help identify potential gaps in care and to enhance unintended pregnancy prevention efforts.Objective: We sought to compare contraceptive method use among HIV-infected and noninfected privately insured women in the United States, and to evaluate the association between antiretroviral therapy use and contraceptive method use.Study Design: We used a large US nationwide health care claims database to identify girls and women ages 15-44 years with prescription drug coverage. We used diagnosis, procedure, and National Drug Codes to assess female sterilization and reversible prescription contraception use in 2008 and 2014 among women continuously enrolled in the database during 2003 through 2008 or 2009 through 2014, respectively. Women with no codes were classified as using no method; these may have included women using nonprescription methods, such as condoms. We calculated prevalence of contraceptive use by HIV infection status, and by use of antiretroviral therapy among those with HIV. We used multivariable polytomous logistic regression to calculate unadjusted and adjusted odds ratios and 95% confidence intervals for female sterilization, long-acting reversible contraception, and short-acting hormonal contraception compared to no method.Results: While contraceptive use increased among HIV-infected and noninfected women from 2008 through 2014, in both years, a lower proportion of HIV-infected women used prescription contraceptive methods (2008: 17.5%; 2014: 28.9%, compared with noninfected women (2008: 28.8%; 2014: 39.8%, P < .001 for both). Controlling for demographics, chronic medical conditions, pregnancy history, and cohort year, HIV-infected women compared to HIV-noninfected women had lower odds of using long-acting reversible contraception (adjusted odds ratio, 0.67; 95% confidence interval, 0.52-0.86 compared to no method) or short-acting hormonal contraception method (adjusted odds ratio, 0.59; 95% confidence interval, 0.50-0.70 compared to no method). In 2014, HIV-infected women using antiretroviral therapy were significantly more likely to use no method (76.8% vs 64.1%), and significantly less likely to use short-acting hormonal contraception (11.0% vs 22.7%) compared to HIV-infected women not using antiretroviral therapy. Those receiving antiretroviral therapy had lower odds of using short-acting hormonal contraception compared to no method (adjusted odds ratio, 0.45; 95% confidence interval, 0.32-0.63). There was no significant difference in female sterilization by HIV status or antiretroviral therapy use.Conclusion: Despite the safety of reversible contraceptives for women with HIV, use of prescription contraception continues to be lower among privately insured HIV-infected women compared to noninfected women, particularly among those receiving antiretroviral therapy. [ABSTRACT FROM AUTHOR]

Background: Little is known about fertility choices and pregnancy outcome rates among HIV-infected women in the current combination antiretroviral treatment era.Objective: We sought to describe trends and factors associated with live-birth and abortion rates among HIV-positive and high-risk HIV-negative women enrolled in the Women's Interagency HIV Study in the United States.Study Design: We analyzed longitudinal data collected from Oct. 1, 1994, through Sept. 30, 2012, through the Women's Interagency HIV Study. Age-adjusted rates per 100 person-years live births and induced abortions were calculated by HIV serostatus over 4 time periods. Poisson mixed effects models containing variables associated with live births and abortions in bivariable analyses (P < .05) generated adjusted incidence rate ratios and 95% confidence intervals.Results: There were 1356 pregnancies among 2414 women. Among HIV-positive women, age-adjusted rates of live birth increased from 1994 through 1997 to 2006 through 2012 (2.85-7.27/100 person-years, P trend < .0001). Age-adjusted rates of abortion in HIV-positive women remained stable over these time periods (4.03-4.29/100 person-years, P trend = .09). Significantly lower live-birth rates occurred among HIV-positive compared to HIV-negative women in 1994 through 1997 and 1997 through 2001, however rates were similar during 2002 through 2005 and 2006 through 2012. Higher CD4+ T cells/mm3 (≥350 adjusted incidence rate ratio, 1.39 [95% CI 1.03-1.89] vs <350) were significantly associated with increased live-birth rates, while combination antiretroviral treatment use (adjusted incidence rate ratio, 1.35 [95% CI 0.99-1.83]) was marginally associated with increased live-birth rates. Younger age, having a prior abortion, condom use, and increased parity were associated with increased abortion rates among both HIV-positive and HIV-negative women. CD4+ T-cell count, combination antiretroviral treatment use, and viral load were not associated with abortion rates.Conclusion: Unlike earlier periods (pre-2001) when live-birth rates were lower among HIV-positive women, rates are now similar to HIV-negative women, potentially due to improved health status and combination antiretroviral treatment. Abortion rates remain unchanged, illuminating a need to improve contraceptive services. [ABSTRACT FROM AUTHOR]