Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation (MMSAP)

MedStar Health

Status and phase: Completed; Phase 4

Conditions: Induced Abortion

Treatments: Drug: Mifepristone; Dietary Supplement: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02412618

2012-245

Details and patient eligibility

About

A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Full description

Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy women
• eligible for non---urgent D&E
• 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

Exclusion criteria

• emergent need for D&E
• fetal demise
• intolerance
• allergy or contraindication to mifepristone or misoprostol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Mifepristone

Active Comparator group

Description:

Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once

Treatment:

Drug: Misoprostol

Drug: Mifepristone

Placebo

Placebo Comparator group

Description:

Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once

Treatment:

Drug: Misoprostol

Dietary Supplement: Placebo