Second Trimester Labor Induction
- Conditions
- Second Trimester Labor Induction
- Interventions
- Drug: Experimental (mifepristone and misoprostol)
- Registration Number
- NCT00592215
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Experimental (mifepristone and misoprostol) Mifepristone followed by labor induction with misoprostol after 6-8 hours
- Primary Outcome Measures
Name Time Method Abortion rate 8 hours after misoprostol administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States