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Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

NCT01768299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2014-05-14

No results posted yet for this study

Summary

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

Conditions

  • Complete Uterine Evacuation After Use of Study Drugs

Interventions

DRUG

Mifepristone

200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol

DRUG

Misoprostol

200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Jennifer Blum, MPH · Gynuity Health Projects

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Dina Abbas, MPH · Gynuity Health Projects

  • Nguyen thi Ngoc, MD · Hung Vuong Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Vietnam

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 NCT01768299 on ClinicalTrials.gov