TerminatedNot Applicable

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

Stopped: Interim analysis showed no difference in outcome between treatment groups.

United States92 participantsStarted 2003-11

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome was spontaneous preterm birth prior to 35 weeks gestation

Timeframe: 11/2003 - 12/2006

Trial details

NCT IDNCT00694967

SponsorLehigh Valley Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-12

View on ClinicalTrials.gov More Mid Trimester Cervical Shortening trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.