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

Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694967

Enrollment

Registered

2008-06-11

Start date

2003-11-30

Completion date

2006-12-31

Last updated

2008-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mid Trimester Cervical Shortening

Keywords

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

Brief summary

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.

Interventions

PROCEDUREMcDonald cerclage placement

Transcervical McDonald cerclage placement

DRUG17 hydroxyprogesterone caproate

Weekly 250mg intramuscular injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome was spontaneous preterm birth prior to 35 weeks gestation	11/2003 - 12/2006

Secondary

Measure	Time frame
Obstetrical complications	11/2003 - 12/2006
Neonatal morbidity & mortality	11/2003 --12/2006

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026