Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

NCT ID: NCT00383032

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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mifepristone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Karen George, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4.

Reference Type DERIVED
PMID: 17963864 (View on PubMed)

Other Identifiers

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CPHS # 16429

Identifier Type: -

Identifier Source: org_study_id

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