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A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

NCT02708446 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2016-07-14

No results posted yet for this study

Summary

The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Conditions

  • Legally Induced Abortion Without Mention of Complication

Interventions

DRUG

Mifepristone

200mg oral mifepristone to both study arms

DRUG

Buccal misoprostol

doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone

DRUG

Sublingual misoprostol

doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

Sponsors & Collaborators

  • La Rabta Maternity Hospital

    collaborator UNKNOWN

  • Republican Institute of RH, Perinatology, and Ob/Gyn

    collaborator UNKNOWN

  • Kathmandu Medical College and Teaching Hospital

    collaborator OTHER

  • Clinic No. 2 of Tashkent Medical Academy

    collaborator UNKNOWN

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Armenia
  • Nepal
  • Tunisia
  • Uzbekistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02708446 on ClinicalTrials.gov