Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)
- Conditions
- Complete Uterine Evacuation After Use of Study Drugs
- Interventions
- Registration Number
- NCT01768299
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 504
- Closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- No contraindications to medical abortion and study procedures, according to provider
- Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
- Willing to follow study procedures
- Known previous transmural uterine incision
- > 5 parity
- Signs and symptoms of infection
- Any contraindications to vaginal delivery, including placenta previa
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mifepristone and first dose of misoprostol simultaneously. Misoprostol Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled. Mifepristone at home 24 hours before miso dosing starts Mifepristone All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.
- Primary Outcome Measures
Name Time Method Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. Within 1 week Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
- Secondary Outcome Measures
Name Time Method Time interval from the mifepristone dose to abortion Within 1 week Defined as length of time from initiation of mifepristone to complete abortion achieved.
Total dose of misoprostol administered Within 1 week Induction to abortion interval Within 1 week Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.
Women's acceptability of the assigned method. Within 1 week Rate of fetal expulsion Within 1 week Defined as fetal expulsion with study drug alone.
Provision of additional interventions Within 1 week For example: Uterine massage, Manual removal, Sponge forceps, D\&C or D\&E, Repeat medical abortion drugs
Trial Locations
- Locations (3)
National Ob-Gyn Hospital
🇻🇳Hanoi, Vietnam
Hung Vuong Hospital
🇻🇳Ho Chi Minh City, Vietnam
Binh duong Obstetrics and Newborn Hospital
🇻🇳Ho Chi Minh City, Binh Duong Province, Vietnam