Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial.

BackgroundEarly pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 μg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure.ObjectiveThis study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss.Study designWe performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment.ResultsOverall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49).ConclusionNo baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors

Six-month Expulsion of Postplacental Copper Intrauterine Devices Placed After Vaginal Delivery

Background Immediate placement of an intrauterine device after vaginal delivery is safe and convenient, but longitudinal data describing clinical outcomes have been limited. Objective We sought to determine the proportion of TCu380A (copper) intrauterine devices expelled, partially expelled, malpositioned, and retained, as well as contraceptive use by 6 months postpartum, and determine risk factors for expulsion and partial expulsion. Study Design In this prospective, observational study, women who received a postplacental TCu380A intrauterine device at vaginal delivery were enrolled postpartum. Participants returned for clinical follow-up at 6 weeks, and for a research visit with a pelvic exam and ultrasound at 6 months. We recorded intrauterine device outcomes and 6-month contraceptive use. Partial expulsion was defined as an intrauterine device protruding from the external cervical os, or a transvaginal ultrasound showing the distal end of the intrauterine device below the internal os of the cervix. Multinomial logistic regression models identified risk factors associated with expulsion and partial expulsion by 6 months. The area under the receiver operating characteristics curve was used to assess the ability of a string check to predict the correct placement of a postplacental intrauterine device. The primary outcome was the proportion of intrauterine devices expelled at 6 months. Results We enrolled 200 women. Of 162 participants with follow-up data at 6 months, 13 (8.0%; 95% confidence interval, 4.7–13.4%) experienced complete expulsion and 26 (16.0%; 95% confidence interval, 11.1–22.6%) partial expulsion. Of 25 malpositioned intrauterine devices (15.4%; 95% confidence interval, 10.2–21.9%), 14 were not at the fundus (8.6%; 95% confidence interval, 5.2–14.1%) and 11 were rotated within the uterus (6.8%; 95% confidence interval, 3.8–11.9%). Multinomial logistic regression modeling indicated that higher parity (odds ratio, 2.05; 95% confidence interval, 1.21–3.50; P = .008) was associated with expulsion. Provider specialty (obstetrics vs family medicine; odds ratio, 5.31; 95% confidence interval, 1.20–23.59; P = .03) and gestational weight gain (normal vs excess; odds ratio, 9.12; 95% confidence interval, 1.90–43.82; P = .004) were associated with partial expulsion. Long-acting reversible contraceptive method use at 6 months was 80.9% (95% confidence interval, 74.0–86.6%). At 6 weeks postpartum, 35 of 149 (23.5%; 95% confidence interval, 16.9–31.1%) participants had no intrauterine device strings visible. Sensitivity of a string check to detect an incorrectly positioned intrauterine device was 36.2%, and specificity of the string check to predict a correctly positioned intrauterine device was 84.5%. This corresponds to an area under the receiver operating characteristics curve of 0.5. Conclusion This prospective assessment of postplacental TCu380A intrauterine device placement, with ultrasound to confirm device position, finds a complete intrauterine device expulsion proportion of 8.0% at 6 months. The association of increasing parity with expulsion is consistent with prior research. The clinical significance of covariates associated with partial expulsion (provider specialty and gestational weight gain) is unclear. Due to the observational study design, any associations cannot imply causality. The proportion of partially expelled and malpositioned intrauterine devices was high, and the area under the receiver operating characteristics curve of 0.5 indicates that a string check is a poor test for assessing device position. Women considering a postplacental intrauterine device should be counseled about the risk of position abnormalities, as well as the possibility of nonvisible strings, which may complicate clinical follow-up. The clinical significance of intrauterine device position abnormalities is unknown; future research should evaluate the influence of malposition and partial expulsion on contraceptive effectiveness and side effects

Satisfaction with Intrauterine Device Insertion Procedure Among Adolescent and Young Adult Women in a Clinical Trial

OBJECTIVE: To evaluate satisfaction with intrauterine device (IUD) insertion procedures among adolescent and young adult women. METHODS: This secondary analysis of data from a multisite, single-blind, sham-controlled randomized trial of women having a levonorgestrel 13.5-mg IUD inserted enrolled participants from March 2015 through July 2016 at three family planning clinics in Philadelphia, Pennsylvania. Eligible participants were 14-22 years of age, nulliparous, not pregnant, and English-speaking. Randomization was computer-generated allocation in block sizes of four to a 1% lidocaine paracervical or sham block. Only patients were blinded. Satisfaction was measured with three items that assessed overall satisfaction with the procedure, whether participants would recommend the IUD to a friend, and the perception that the IUD was worth the discomfort. Predictors included demographics, sexual and reproductive history, pain after IUD insertion, and treatment group. RESULTS: Ninety-five women enrolled; 93 (97.9%) were included in the analysis. Forty-five (47.4%) were white, 34 (36.0%) were black, 62 (66.0%) were privately insured, and 75 (79.0%) had used contraception previously. Most (n=73 [76.8%]) reported high overall satisfaction with the procedure, 64 (67.4%) would recommend an IUD to a friend, and 79 (83.2%) perceived the IUD was worth the discomfort. The odds of reporting high overall satisfaction were lower among adolescents compared with young adults (odds ratio [OR] 0.07, 95% CI 0.008-0.68); those who never had a gynecologic examination compared with those who had (OR 0.26, 95% CI 0.07-0.99); and decreased as pain score increased (OR 0.96, 95% CI 0.94-0.99). Higher pain scores were negatively correlated with the odds of recommending an IUD to a friend and perceiving the IUD was worth the discomfort. CONCLUSION: Adolescent and young adult women report high levels of satisfaction after the IUD insertion procedure. Young age, lack of experience with gynecologic examinations, and high pain were inversely related to satisfaction

Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss

BACKGROUND Medical management of early pregnancy loss is an alternative to uterine aspira-tion, but standard medical treatment with misoprostol commonly results in treat-ment failure. We compared the efficacy and safety of pretreatment with mifepris-tone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss. METHODS We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, administered orally, followed by 800 µg of misoprostol, adminis-tered vaginally (mifepristone-pretreatment group), or 800 µg of misoprostol alone, administered vaginally (misoprostol-alone group). Participants returned 1 to 4 days after misoprostol use for evaluation, including ultrasound examination, by an in-vestigator who was unaware of the treatment-group assignments. Women in whom the gestational sac was not expelled were offered expectant management, a second dose of misoprostol, or uterine aspiration. We followed all participants for 30 days after randomization. Our primary outcome was gestational sac expulsion with one dose of misoprostol by the first follow-up visit and no additional intervention within 30 days after treatment. RESULTS Complete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8 to 89.3) in the mifepristone-pretreat-ment group and in 100 of 149 women (67.1%; 95% CI, 59.0 to 74.6) in the miso-prostol-alone group (relative risk, 1.25; 95% CI, 1.09 to 1.43). Uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21 to 0.68). Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P = 0.31); pelvic infection was diagnosed in 1.3% of the women in each group. CONCLUSIONS Pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone. (Funded by the National Institute of Child Health and Human Development; PreFaiR ClinicalTrials.gov number, NCT02012491.

Programmatic aspects of postpartum family planning in developing countries: a qualitative analysis of key informant interviews in Kenya and Ethiopia

To achieve the improved maternal and child outcomes of birth spacing, family planning in the postpartum period is essential. The objective of this study is to determine the perceptions regarding programmatic aspects of postpartum family planning by key informants in 17 countries determined to have high unmet need for postpartum family planning. We present interim data from structured interviews of key informants in Kenya and Ethiopia. Important themes included the need for documentation of contraceptive use to aid in commodity assessment and delivery, need for additional informational materials, and challenges of delivering services to those women who deliver away from a health care facility.Pour atteindre les meilleurs résultats de l’espacement des naissances par rapport à la mère et à l’enfant, il faut de la planification familiale dans la période du post-partum. L'objectif de cette étude est de déterminer les perceptions concernant les aspects programmatiques de la planification familiale du post-partum par les informateurs clés dans 17 pays soucieux d’avoir un haut niveau de besoin non satisfait de planification familiale du post-partum. Nous présentons des données provisoires issues d'entretiens structurés recueillis des informateurs clés au Kenya et en Ethiopie. Parmi les thèmes importants était la nécessité pour la documentation de l'utilisation des contraceptifs pour aider l'évaluation et la livraison des marchandise, le besoin de documents d'information supplémentaires, et les défis de la prestation de services à ces femmes-là qui accouchent loin d'un établissement de santé

Barriers to Immediate Postplacental Intrauterine Devices Among Attending Level Educators [190]

To determine whether barriers to immediate post-placental intrauterine device (PPIUD) placement exist at the provider level. Obstetrics providers at seven academic teaching hospitals in Massachusetts were asked to complete an electronic survey regarding their knowledge, experience, and opinions about immediate PPIUDs. Eighty-two providers, including obstetricians, family medicine physicians, and midwives, completed the survey. Thirty-five (42.7%) reported experience placing an immediate PPIUD with the majority of them having placed three to five PPIUDs. Of participants who had never placed a PPIUD, the reason cited most frequently was inadequate training. Fewer than one-half (43.4%) correctly identified the PPIUD expulsion rate, whereas 75.9% knew the correct expulsion rate for interval IUD placement. The majority of providers responded that PPIUDs are acceptable in certain clinical scenarios. Overall, knowledge and experience with PPIUD placement is relatively low. As increasing numbers of states amend Medicaid policy to include reimbursement for immediate postpartum IUDs, additional education and training opportunities are needed

Characterizing Twitter Content About HIV Pre-exposure Prophylaxis (PrEP) for Women: Qualitative Content Analysis

BackgroundHIV remains a persistent health problem in the United States, especially among women. Approved in 2012, HIV pre-exposure prophylaxis (PrEP) is a daily pill or bimonthly injection that can be taken by individuals at increased risk of contracting HIV to reduce their risk of new infection. Women who are at risk of HIV face numerous barriers to HIV services and information, underscoring the critical need for strategies to increase awareness of evidence-based HIV prevention methods, such as HIV PrEP, among women. ObjectiveWe aimed to identify historical trends in the use of Twitter hashtags specific to women and HIV PrEP and explore content about women and PrEP shared through Twitter. MethodsThis was a qualitative descriptive study using a purposive sample of tweets containing hashtags related to women and HIV PrEP from 2009 to 2022. Tweets were collected via Twitter’s API. Each Twitter user profile, tweet, and related links were coded using content analysis, guided by the framework of the Health Belief Model (HBM) to generate results. We used a factor analysis to identify salient clusters of tweets. ResultsA total of 1256 tweets from 396 unique users were relevant to our study focus of content about PrEP specifically for women (1256/2908, 43.2% of eligible tweets). We found that this sample of tweets was posted mostly by organizations. The 2 largest groups of individual users were activists and advocates (61/396, 15.4%) and personal users (54/396, 13.6%). Among individual users, most were female (100/166, 60%) and American (256/396, 64.6%). The earliest relevant tweet in our sample was posted in mid-2014 and the number of tweets significantly decreased after 2018. We found that 61% (496/820) of relevant tweets contained links to informational websites intended to provide guidance and resources or promote access to PrEP. Most tweets specifically targeted people of color, including through the use of imagery and symbolism. In addition to inclusive imagery, our factor analysis indicated that more than a third of tweets were intended to share information and promote PrEP to people of color. Less than half of tweets contained any HBM concepts, and only a few contained cues to action. Lastly, while our sample included only tweets relevant to women, we found that the tweets directed to lesbian, gay, bisexual, transgender, queer (LGBTQ) audiences received the highest levels of audience engagement. ConclusionsThese findings point to several areas for improvement in future social media campaigns directed at women about PrEP. First, future posts would benefit from including more theoretical constructs, such as self-efficacy and cues to action. Second, organizations posting on Twitter should continue to broaden their audience and followers to reach more people. Lastly, tweets should leverage the momentum and strategies used by the LGBTQ community to reach broader audiences and destigmatize PrEP use across all communities