Second Trimester Labor Induction

NCT ID: NCT00592215

Last Updated: 2017-12-08

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-10-31

Brief Summary

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A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.

The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.

Detailed Description

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Conditions

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Second Trimester Labor Induction

Keywords

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Second trimester labor induction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Mifepristone followed by labor induction with misoprostol after 6-8 hours

Group Type EXPERIMENTAL

Experimental (mifepristone and misoprostol)

Intervention Type DRUG

Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours

Interventions

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Experimental (mifepristone and misoprostol)

Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* English-speaking women
* 18 years of age and above
* Voluntarily choose to undergo pregnancy termination via labor induction
* An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
* Able to provide written consent

Exclusion Criteria

* Premature rupture of membranes
* Preterm labor
* Intrauterine fetal demise
* Chronic systemic corticosteroid use or adrenal disease
* Hypersensitivity to prostaglandins
* Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
* Known coagulopathy or treatment with anticoagulants
* Prior caesarean delivery or myomectomy
* Placenta previa
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rameet Singh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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2007-663

Identifier Type: -

Identifier Source: secondary_id

NA_00010268

Identifier Type: -

Identifier Source: org_study_id