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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2014

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.

Interventions

  • Drug: Mifepristone
    • Progesterone antagonist
  • Drug: Misoprostol
    • Prostaglandin E1
  • Dietary Supplement: Placebo
    • Tasteless, odorless, sugar based pill

Arms, Groups and Cohorts

  • Active Comparator: Mifepristone
    • Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once
  • Placebo Comparator: Placebo
    • Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medstar Health Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor

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