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

Induced Abortion Clinical Trial

— MMSAP  

Official title:

A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412618
• Other study ID #: 2012-245
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2022
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Drug:
• Mifepristone
Progesterone antagonist
• Misoprostol
Prostaglandin E1

Dietary Supplement:
• Placebo
Tasteless, odorless, sugar based pill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial Cervical Dilation	Initial cervical dilation as measured by Hegar Dilator accepted with least resistance	Assessed 4-6 hour following medications at time of D&E procedure
Secondary	Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)	5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends.; Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)	intraoperative