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Second Trimester Labor Induction

This study has been terminated.
Sponsor:
Collaborator:
University of Maryland
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00592215
First received: December 31, 2007
Last updated: June 9, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Second Trimester Labor Induction
 Drug: Experimental (mifepristone and misoprostol)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Abortion rate [ Time Frame: 8 hours after misoprostol administration ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Mifepristone followed by labor induction with misoprostol after 6-8 hours
 Drug: Experimental (mifepristone and misoprostol)
Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592215

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Johns Hopkins University
University of Maryland
  More Information

No publications provided

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00592215     History of Changes
Other Study ID Numbers: NA_00010268, 2007-663
Study First Received: December 31, 2007
Last Updated: June 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Second trimester labor induction

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
 Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on May 19, 2013