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Mifepristone and Mid-Trimester Termination of Pregnancy

NCT00382538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2008-10-07

No results posted yet for this study

Summary

Mid-second trimester medical terminations of pregnancy require admission to the hospital for the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic digoxin injection the day prior to admission. The following day, the woman is admitted and given sequential doses of misoprostol until delivery occurs. The average length of time between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay overnight. This is a randomized, placebo-controlled, double-blinded study designed to determine whether adding mifepristone significantly reduces the induction interval time (time between starting the first misoprostol and delivery) required for a second trimester termination.

Conditions

  • Abortion, Induced
  • Abortion, Second Trimester

Interventions

DRUG

Addition of mifepristone 200 mg 24 hours before induction

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Lynn Borgatta, MD, MPH · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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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 NCT00382538 on ClinicalTrials.gov