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A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix

NCT ID: NCT00694967

Last Updated: 2008-06-11

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

TERMINATED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-12-31

Brief Summary

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We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.

Detailed Description

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Conditions

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Mid Trimester Cervical Shortening

Keywords

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short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

McDonald cerclage

Group Type ACTIVE_COMPARATOR

McDonald cerclage placement

Intervention Type PROCEDURE

Transcervical McDonald cerclage placement

2

17 hydroxyprogesterone caproate

Group Type ACTIVE_COMPARATOR

17 hydroxyprogesterone caproate

Intervention Type DRUG

Weekly 250mg intramuscular injections

Interventions

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McDonald cerclage placement

Transcervical McDonald cerclage placement

Intervention Type PROCEDURE

17 hydroxyprogesterone caproate

Weekly 250mg intramuscular injections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ultrasonographic evidence of premature dilatation of the internal os
* Prolapse of the chorio-amniotic membranes into the endocervical canal
* Functional cervical length less than 25mm
* Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure

Exclusion Criteria

* Any fetal chromosomal or structural anomaly
* Multiple gestation
* Known allergy to progesterone
* Ruptured membranes
* Vaginal bleeding
* Intra-amniotic infection (diagnosed clinically or by amniocentesis)
* Prolapse of endocervical membranes beyond the external cervical os
* Persistent uterine activity accompanied by cervical change
* Obstetrically indicated delivery.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lehigh Valley Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lehigh Valley Hospital

Principal Investigators

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Orion Rust, M.D

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Locations

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Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2003103

Identifier Type: -

Identifier Source: org_study_id