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Completed

NCT Number: NCT02412618

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

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.

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Key information

Conditions

Induced Abortion

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Progesterone antagonist

Other names: Mifeprex

Misoprostol

Drug

Prostaglandin E1

Other names: Cytotec

Placebo

Dietary Supplement

Tasteless, odorless, sugar based pill

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Acronym: MMSAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2015
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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