Purpose: To evaluate the feasibility and acceptability of outpatient medical induction at 13-18 weeks' gestation to limit overnight hospital stays.
Methods: In this prospective cohort study, participants with 13-18-week pregnancies seeking abortions at two government hospitals swallowed mifepristone 200 mg and self-administered misoprostol 400 mcg buccally 24-48 h later, 1-2 h before returning to the outpatient clinic (OPD). Repeat misoprostol was dosed every 3 h until expulsion.
Background: Induction of labor (IOL) is an increasingly common intervention, but experiences and preferences of induction methods are under-researched particularly in low -and middle-income countries. Understanding these perspectives is important to improve the childbirth experience.
Objective: To explore the experiences and preferences of IOL methods for women, clinicians, and researchers in the "Misoprostol or Oxytocin for Labour Induction" (MOLI) study.
Objective: To evaluate safety, feasibility, and acceptability of a telemedicine medical abortion service without pre-treatment in-person tests in Ukraine, Uzbekistan, and Azerbaijan.
Methods: We conducted an open-label, prospective, observational clinical study at five clinics in the three countries. Interested and eligible participants scheduled a telemedicine consultation with a study provider by phone or video.
Objectives: This study aimed to assess the feasibility, safety, and acceptability of asynchronous screening for medication abortion eligibility using a programmed questionnaire.
Study Design: For this study, we developed an informational website about medication abortion with a linked questionnaire programmed to produce a conclusion regarding eligibility according to standard criteria. We enrolled people in Colorado and Minnesota who submitted questionnaires indicating eligibility.
Background: Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants' views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on participants, according to their own priorities. Conversely, purely qualitative assessments are time consuming and usually restricted to a small, possibly unrepresentative, sub-sample.
View Article and Find Full Text PDFPrior studies indicate that PAPP-A could serve as a marker of gestational age (GA) with the potential to determine eligibility for medication abortion. The authors validated the relationship between PAPP-A and GA in an actual-use population. The authors collected blood samples, medical histories and ultrasound-determined GA from patients presenting for abortion services.
View Article and Find Full Text PDFObjective: To assess the feasibility and acceptability of misoprostol as a treatment option for incomplete abortion in secondary hospitals in Yangon and Mandalay, Myanmar.
Methods: An explanatory sequential mixed methods study was conducted. Women seeking treatment for an incomplete abortion with a uterine size <12 weeks were eligible to participate in the prospective cohort including sublingual administration of 400 μg misoprostol, clinical assessment 7-10 days after administration, and patient interview.
Objective: Given the substantial barriers to abortion access in the United States, many clinics now mail patients abortion medications. We examined whether dispensing the medications by mail prolonged time to medication use.
Study Design: We analyzed data from no-test medication abortions with medication provided either by mail or in a clinic from 11 United States clinics from February 2020 to January 2021.
A retrospective study of abortion facilities in and around Texas by White et al. and a spatial analysis by Rader et al. are combined to illustrate the detrimental effects of abortion bans enacted in the United States.
View Article and Find Full Text PDFObjectives: We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40 participants seeking medication abortion up to 63 days' gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 days later by misoprostol 800 mcg buccally at home. They took a second dose of misoprostol if they had no bleeding within 24 hours of the first.
View Article and Find Full Text PDFImportance: Screening for medication abortion eligibility typically includes ultrasonography or pelvic examination. To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring tests before medication abortion and instead screened patients for pregnancy duration and ectopic pregnancy risk by history alone. However, few US-based studies have been conducted on the outcomes and safety of this novel model of care.
View Article and Find Full Text PDFObjective: Medical menstrual regulation (MMR) may offer a promising way to reach Senegalese women and girls in need of fertility management, especially in rural contexts. To assess the feasibility of introducing a MMR service in Senegal, the study aimed to (1) understand how women and girls manage their menses and fertility, and (2) document acceptability of MMR among women, youth, and health providers.
Methods: Six focus group discussions and 34 in-depth interviews were conducted with women, youth, and health providers in Kaolack, Mbour, and Thiès, Senegal.
Post-sedation escort policies are not evidence-based but traditional consensus recommendations made by professional societies. As people travel further for abortion care, escort policies are increasingly difficult to navigate and force people to delay care, compromise privacy, or undergo procedures without sedation. At worst, clinics may turn away people who present without an escort.
View Article and Find Full Text PDFPharmacies in low- and middle-income countries play an important role in increasing the availability of medical abortion to individuals for self-use. We aimed to document the costs to users of medical abortion products at outlets across geographies and understand the diversity of available products, primarily in low- and middle-income countries or in places where access to abortion is restricted. A descriptive analysis of price data was completed for identified medical abortion products at retail outlets visited in 44 countries from November 2017 to February 2018.
View Article and Find Full Text PDFObjectives: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15.
View Article and Find Full Text PDFObjectives: To compare outcomes among patients who did or did not have pre-abortion ultrasound or pelvic exam before obtaining medication abortion (MA) via direct-to-patient telemedicine and mail.
Study Design: We analyzed data from participants screened for enrollment into the TelAbortion study at five sites from March 25 to September 15, 2020. We compared participants who had preabortion ultrasound or pelvic exam ("test-MA") to those who did not ("no-test MA").
Background: Accurate pregnancy dating is critical for maternal and child health and for counseling on safe and effective abortion methods. While last menstrual period and first trimester ultrasound are often used together to determine gestational age (GA), they have limited accuracy and availability, respectively. Prior studies have shown that pregnancy-associated plasma protein-A (PAPP-A) increases exponentially during pregnancy and has the potential to serve as a biochemical marker of GA.
View Article and Find Full Text PDFObjective: To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials.
Study Design: We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale.
Objective: To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic.
Study Design: We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any needed preabortion tests locally and had a videoconference with a study clinician.
Objective: We aimed to determine the risk of postpartum infection and increased pain associated with use of condom-catheter uterine balloon tamponade (UBT) among women diagnosed with postpartum hemorrhage (PPH) in three low- and middle-income countries (LMICs). We also sought women's opinions on their overall experience of PPH care.
Methods: This prospective cohort study compared women diagnosed with PPH who received and did not receive UBT (UBT group and no-UBT group, respectively) at 18 secondary level hospitals in Uganda, Egypt, and Senegal that participated in a stepped wedge, cluster-randomized trial assessing UBT introduction.
Background: Misfolded proteins in the urine of women with preeclampsia bind to Congo Red dye (urine congophilia). We evaluated a beta prototype of a point-of-care test for the identification of urine congophilia in preeclamptic women.
Methods: Prospective diagnostic case-control study conducted in 409 pregnant women ( = 204 preeclampsia; = 205 uncomplicated pregnancies) presenting for delivery in two tertiary level hospitals located in Bangladesh and Mexico.