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NCT02412618 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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