A Phase 4 interventional study of Mifepristone + Misoprostol in Abortion in Second Trimester, sponsored by Gynuity Health Projects. Completed at 2 sites in Nepal. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation in two public sector facilities. It also seeks to document the roles of health workers in providing services related to later abortion care and to document the costs of this day procedure to the health system.
Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
Drug: Mifepristone + Misoprostol
A single 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally (buccal) every three hours until the abortion is achieved.
Proportion of participants with method success on the same day as misoprostol initiation.
Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day
Time frame: 0 - 48 hours after first dose of mifepristone
Average induction-to-abortion interval
Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta
Time frame: 0 - 48 hours after first misoprostol dose
Average number of total doses of misoprostol
Total misoprostol doses administered from induction to delivery of placenta.
Time frame: 0 - 48 hours after first misoprostol dose
Frequency of adverse events
Adverse events include extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, or prolonged hospitalization, any complications (immediate and delayed)
Time frame: 0-2 weeks after initial visit
Description of tasks performed by different cadres of study staff
Tasks evaluated include counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge
Time frame: 0 - 72 hours after receipt of mifepristone
Average total hospital admission time
Total hospital admission time, including: 1) total admission time during treatment with misoprostol and abortion recovery 2) Additional hospital time required for the evaluation and management of complications
Time frame: Within 0 - 48 hours after the second dose of misoprostol
Average pain scores
Severity incidence based on a 0-10 point pain scale
Time frame: 0 - 48 hours after first dose of misoprostol
Frequency of individual side effects experienced by participants
Side effects evaluated include diarrhea, nausea, vomiting, fever, chills
Time frame: 0 - 48 hours after first dose of misoprostol
Proportion of reported complications
Participants who returned to a health facility for evaluation and management of complications within 2 weeks of taking mifepristone
Time frame: 0-2 weeks after initial visit
Proportion of satisfied participants
Participants who report high satisfaction with service
Time frame: 2 weeks after initial visit
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects