Feasibility of a hospital outpatient day procedure for medication abortion at 13–18 weeks gestation: findings from Nepal
by Jennifer Blum, Chandra Karki, Anand Tamang, Tara Shichet, Achala Shresthra. Heera Tuladhar, Aruna Karki, Jyotsna Sharma, Dina F Abbas, Monica Dragoman, Beverly Winikoff
Contraception 2019(Dec);100(6):451-56 DOI: 10.1016/j.contraception.2019.08.007
Objectives: To evaluate the safety, acceptability and feasibility of a one-day outpatient medical abortion service at gestations 13–18 weeks.
Study design: Open-label prospective study in which participants received mifepristone 200 mg orally to swallow at home or at the clinic followed 24 h later by misoprostol 400 mcg buccally. They presented to the outpatient clinic 24–48 h after mifepristone for misoprostol 400 mcg buccally every three hours (no maximum dose). The primary outcome was successful abortion without transfer to overnight inpatient care. Secondary outcomes included time to abortion from initial misoprostol dose, safety, additional interventions and side effects.
Results: We enrolled 230 women from December 2017 to November 2018. Approximately nine of ten (n = 206, 89.6%) achieved a successful abortion without transfer to overnight care. Twenty-four were transferred to overnight inpatient care; of these 18 were to manage a complication, five for incomplete abortion and two by choice. Among these 24, three women experienced a serious adverse effect. The median time to successful abortion from time of the first misoprostol dose was 7.2 h (range: 0.75–92.3), with an average of three misoprostol doses. Most participants expelled the fetus and the placenta at or around the same time; median time between fetal and placental expulsion was 15 minutes (range: 0–4.5 h). Fifteen participants (6.6%) received more than five misoprostol doses and were transferred to inpatient care. Administration of more than five doses of misoprostol was associated with nulliparity. Provision of antibiotics (27.9%,n = 64), manual removal of placenta (15.3%,n = 35), uterotonics (4.4%,n = 10) and surgical interventions (4.4%,n = 10) were also reported. About one in four participants experienced nausea, vomiting and chills; fever was infrequent (2.5%,n = 5).
Conclusions: For gestations 13-18 weeks, an outpatient day process for medication abortion is safe, effective and feasible.
Implications: Medical abortion in 13-18 weeks need not be limited to inpatient care; nine of ten cases can be managed as an outpatient day service.
Complications associated with second trimester inductions of labor requiring greater than five doses of misoprostol
by Nicole M Masse, Kristine Kuchta, Beth A Plunkett, David W Ouyang
Contraception 2020 (Jan);101(1):53-55 (Open access)
Objective: To evaluate outcomes associated with induction at 14 weeks 0 days–23 weeks 6 days gestation that require five or less vs. six or more misoprostol doses.
Study design: We performed a retrospective study of vaginal misoprostol inductions from January 2003 to February 2016 to assess complications based on number of misoprostol doses.
Results: Among 390 women receiving five or fewer doses and 78 women receiving six or more doses, we found similar rates of chorioamnionitis, postpartum hemorrhage, transfusion and retained placenta.
Conclusion: Complication rates were comparable in women receiving more than five versus less than five misoprostol doses for labor induction in the second trimester.
Implications: Women undergoing second trimester induction undelivered after five doses of misoprostol can receive additional doses without any concern for increased complications.
Label comprehension of a combined mifepristone and misoprostol product for medical abortion: A pilot study in South Africa
by Nathalie Kapp, Jewelle Methazia, Elisabeth Eckersberger, Risa Griffin, Tshegofatso Bessenaar
Contraception 2020(Jan);101(1):46-52 (Not open access)
Objectives – As an important next step in developing an over-the-counter (OTC) misoprostol-mifepristone product, this study aims to assess the comprehension of a medical abortion label.
Study design – We conducted a pilot study utilizing convenience sampling to enroll women in rural and urban communities at four sites in two South African provinces. Trained, female recruiters prescreened and consented potential participants. Included women were aged 16–45 with some literacy (assessed by Rapid Estimate of Adult Literacy in Medicine). Exclusion criteria were having ever used or assisted someone with a medical abortion. Demographic data were collected after enrolment. We gave women time to read the prototype label, then asked a series of 35 questions to assess key concepts for correct use of the drug. For all questions but the indication, women could refer to the label while answering. We used descriptive, chi-square and regression analyses to assess comprehension of concepts.
Results – 100 women aged 16–45 years participated. Most reported prior sexual intercourse (91%), pregnancy (75%), and prior contraceptive use (male condom, 45%). Messages clear to participants (>90%) regardless of literacy were: when to consult a doctor before use (history of anemia or ectopic pregnancy), to respect the mifepristone- misoprostol interval, when to seek medical attention (heavy, prolonged or no bleeding) and that fertility returns quickly after abortion. The average scores were moderate for comprehension of all medical abortion label comprehension concepts: 79% for questions about the indication of the product; 73% for assessment of appropriate gestational age; 76% for screening out ectopic pregnancy; 80% for identifying contraindications to the medicines; 69% for instructions on use; 76% for when and for what conditions to seek medical care; and 60% for how to follow-up after abortion with a pregnancy test. Questions with lowest comprehension regarded medication timing, where women with higher literacy were significantly more likely to understand the label than among lower literacy levels.
Conclusions – Our prototype over-the-counter label for a combined mifepristone-misoprostol product for medical abortion in early pregnancy was moderately understandable to participants. Comprehension scores were largely dependent on literacy levels. To demonstrate an understanding of at least 80% for key concepts, the prototype label for a combined medical abortion product requires revision.