Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

This study has been completed.
Sponsor:
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00383032
First received: September 28, 2006
Last updated: December 27, 2007
Last verified: December 2007
  Purpose

Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.


Condition Intervention
Abortion, Induced
Drug: mifepristone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • induction to delivery time

Secondary Outcome Measures:
  • pain
  • delivery within 24 hours
  • need for post-partum D&C
  • adverse events

Estimated Enrollment: 72
Study Start Date: January 2004
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation
  • age greater than 16
  • able to speak English

Exclusion Criteria:

  • prior uterine scar or
  • allergy or history of bad reaction to any of the study drugs or
  • history of chronic adrenal failure or
  • porphyria or
  • concurrent long-term corticosteroid treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00383032

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Karen George, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided by Dartmouth-Hitchcock Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00383032     History of Changes
Other Study ID Numbers: CPHS # 16429
Study First Received: September 28, 2006
Last Updated: December 27, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014