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

History of Changes

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:

Drug Information available for: Mifepristone

U.S. FDA Resources

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

No publications provided by Dartmouth-Hitchcock Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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

ClinicalTrials.gov processed this record on May 19, 2013

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