Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383032
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : January 3, 2008
Information provided by:
Dartmouth-Hitchcock Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Abortion, Induced Drug: mifepristone Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction
Study Start Date : January 2004
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. induction to delivery time

Secondary Outcome Measures :
  1. pain
  2. delivery within 24 hours
  3. need for post-partum D&C
  4. adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383032

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00383032     History of Changes
Other Study ID Numbers: CPHS # 16429
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: January 3, 2008
Last Verified: December 2007

Additional relevant MeSH terms:
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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