Outpatient Service for Mid-trimester Termination of Pregnancy
- Registration Number
- NCT03346629
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone 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 every three hours until the abortion is achieved.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 230
- Have an ongoing pregnancy of 13-18 weeks gestation
- Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
- Has access to a phone where she can be reached at the 2-week follow-up
- Be willing to follow study procedures
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- More than one prior cesarean delivery
- Living more than 2 hours away from the hospital
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mifepristone + Misoprostol Mifepristone + Misoprostol Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
- Primary Outcome Measures
Name Time Method Successful medical abortion 0 - 48 hours after first dose of mifepristone Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction
- Secondary Outcome Measures
Name Time Method Total dose of misoprostol 0 - 48 hours after first misoprostol dose Average number of doses of misoprostol
Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications 2 weeks after initial visit Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
Hospital admission time Within 0 - 48 hours after the second dose of misoprostol Average total hospital admission time
Induction-to-abortion interval 0 - 48 hours after first misoprostol dose Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta
Tasks performed by certified staff 0 - 72 hours after receipt of mifepristone Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge)
Side Effects 0 - 48 hours after first dose of misoprostol Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale)
Initiation-to-abortion interval 0 - 72 hours after receipt of mifepristone Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta
Trial Locations
- Locations (3)
Kathmandu Model Hospital
🇳🇵Kathmandu, Nepal
Kathmandu Medical College
🇳🇵Kathmandu, Nepal
KIST Medical College, Teaching Hospital
🇳🇵Imadol, Lalitpur, Nepal