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

February 8, 2022 updated by: Medstar Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mifepristone
Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
Drug: Mifepristone
Progesterone antagonist
Other Names:
  • Mifeprex
Drug: Misoprostol
Prostaglandin E1
Other Names:
  • Cytotec
Placebo Comparator: Placebo
Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once
Drug: Misoprostol
Prostaglandin E1
Other Names:
  • Cytotec
Dietary supplement: Placebo
Tasteless, odorless, sugar based pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Cervical Dilation
Time Frame: Assessed 4-6 hour following medications at time of D&E procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)
Time Frame: intraoperative

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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