A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion
- Conditions
- Legally Induced Abortion Without Mention of Complication
- Interventions
- Registration Number
- NCT02708446
- Lead Sponsor
- Gynuity Health Projects
- Brief Summary
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
- Detailed Description
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 320
- Meet criteria to obtain abortion
- Present with closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- Have no contraindications to study procedures, according to provider
- Be able to consent to procedure, either by reading consent document or by having consent document read to her
- Be willing to follow study procedures
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- 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 Buccal misoprostol Buccal misoprostol 200mg mifepristone + 400mcg buccal misoprostol q3h Sublingual misoprostol Sublingual misoprostol 200mg mifepristone + 400mcg sublingual misoprostol q3h Sublingual misoprostol Mifepristone 200mg mifepristone + 400mcg sublingual misoprostol q3h Buccal misoprostol Mifepristone 200mg mifepristone + 400mcg buccal misoprostol q3h
- Primary Outcome Measures
Name Time Method Rate of successful abortion by 24 hours 24 hours following the start of misoprostol Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
Rate of successful abortion by 48 hours 48hours following the start of misoprostol Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
- Secondary Outcome Measures
Name Time Method Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta). 48 hours Pain scale (1-7) as reported by women on questionnaire from first drug dose to complete expulsion as documented on study forms, up to 72 hours Percentage of patients requiring provision of additional interventions. from first drug dose to complete expulsion as documented on study forms, up to 72 hours Total number of doses of misoprostol. from first drug dose to complete expulsion as documented on study forms, up to 72 hours Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire from first drug dose to complete expulsion as documented on study forms, up to 72 hours Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment 1 month
Trial Locations
- Locations (4)
Clinic No. 2, Tashkent Medical Academy
🇺🇿Tashkent, Uzbekistan
b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)
🇦🇲Yerevan, Armenia
Kathmandu Medical College
🇳🇵Kathmandu, Nepal
La Rabta Maternity Hospital
🇹🇳Tunis, Tunisia