A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)
Overview
- Phase
- Phase 4
- Intervention
- Mifepristone
- Conditions
- Legally Induced Abortion Without Mention of Complication
- Sponsor
- Gynuity Health Projects
- Enrollment
- 320
- Locations
- 4
- Primary Endpoint
- Rate of successful abortion by 24 hours
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Sublingual misoprostol
200mg mifepristone + 400mcg sublingual misoprostol q3h
Intervention: Mifepristone
Sublingual misoprostol
200mg mifepristone + 400mcg sublingual misoprostol q3h
Intervention: Sublingual misoprostol
Buccal misoprostol
200mg mifepristone + 400mcg buccal misoprostol q3h
Intervention: Mifepristone
Buccal misoprostol
200mg mifepristone + 400mcg buccal misoprostol q3h
Intervention: Buccal misoprostol
Outcomes
Primary Outcomes
Rate of successful abortion by 24 hours
Time Frame: 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
Time Frame: 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 Outcomes
- 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)