Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

NCT ID: NCT00986921

Last Updated: 2014-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-03-31

Brief Summary

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Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Detailed Description

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Conditions

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Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mifepristone

women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.

Group Type EXPERIMENTAL

mifepristone 200 mg

Intervention Type DRUG

mifepristone would be given the day before the procedure

Osmotic dilator insertion

Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure

Group Type ACTIVE_COMPARATOR

osmotic dilator insertion

Intervention Type DEVICE

osmotic dilators (3-6) would be inserted as usual the day before the procedure

Interventions

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mifepristone 200 mg

mifepristone would be given the day before the procedure

Intervention Type DRUG

osmotic dilator insertion

osmotic dilators (3-6) would be inserted as usual the day before the procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria

* multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Lynn Borgatta

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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L B, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.

Reference Type DERIVED
PMID: 22682721 (View on PubMed)

Other Identifiers

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SAMi

Identifier Type: -

Identifier Source: org_study_id

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