Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

This study has been completed.

Sponsored by:	Dartmouth-Hitchcock Medical Center
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00383032

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

Drug Information available for: Mifepristone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction

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

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

Publications indexed to this study:

Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. Epub 2007 Oct 4.

Study ID Numbers:	CPHS # 16429
Study First Received:	September 28, 2006
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00383032
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Mifepristone

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 14, 2009