NCT00439374

RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix

A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.

Detailed description

Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?

Conditions

• Preterm Delivery
• Cervical Length

Interventions

Type	Name	Description
DRUG	17 alpha-hydroxyprogesterone caproate	Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
OTHER	Placebo Oil	Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative

Timeline

• Start date: 2007-04-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2007-02-23
• Last updated: 2019-07-15
• Results posted: 2019-04-11

Locations

14 sites across 1 country: United States