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Clinical Trials/NCT00592215
NCT00592215
Withdrawn
Phase 1

A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion

Johns Hopkins University2 sites in 1 countryMarch 2008

Overview

Phase
Phase 1
Intervention
Experimental (mifepristone and misoprostol)
Conditions
Second Trimester Labor Induction
Sponsor
Johns Hopkins University
Locations
2
Primary Endpoint
Abortion rate
Status
Withdrawn
Last Updated
8 years ago

Overview

Brief Summary

A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.

The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
October 2010
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English-speaking women
  • 18 years of age and above
  • Voluntarily choose to undergo pregnancy termination via labor induction
  • An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
  • Able to provide written consent

Exclusion Criteria

  • Premature rupture of membranes
  • Preterm labor
  • Intrauterine fetal demise
  • Chronic systemic corticosteroid use or adrenal disease
  • Hypersensitivity to prostaglandins
  • Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
  • Known coagulopathy or treatment with anticoagulants
  • Prior caesarean delivery or myomectomy
  • Placenta previa

Arms & Interventions

A

Mifepristone followed by labor induction with misoprostol after 6-8 hours

Intervention: Experimental (mifepristone and misoprostol)

Outcomes

Primary Outcomes

Abortion rate

Time Frame: 8 hours after misoprostol administration

Study Sites (2)

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