Second Trimester Labor Induction

Withdrawn before enrolling · Phase 1

Conditions studied: Second Trimester Labor Induction

In brief

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.

Key facts

Study ID

NCT00592215

Run by

Johns Hopkins University

People needed

0

Starts

2008-03-01

Expected to finish

2010-10-01

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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