Official Title: “A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Drug: Experimental (mifepristone and misoprostol)
  • Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Mifepristone followed by labor induction with misoprostol after 6-8 hours

Primary Measures

• Abortion rate
  • Time Frame: 8 hours after misoprostol administration
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Johns Hopkins University

Overall Clinical Trial Officials and Contacts

Rameet Singh, MD, MPH Principal Investigator Johns Hopkins University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00592215

Study ID Number: NA_00010268

ClinicalTrials.gov Identifier: NCT00592215

Health Authority: United States: Institutional Review Board