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

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...

Date First Received: February 21, 2007

Last Updated: December 16, 2009

Verified by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), September 2009

Clinical Trial Phase: Phase 3 | Start Date: April 2007

Overall Status: Recruiting

Estimated Enrollment: 1000

Brief Summary

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

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Study Primary Completion Date: April 2010

Detailed Clinical Trial 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?

Intervention(s) in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Delivery prior to 37 weeks
    • Time Frame: Delivery
      Safety Issue?: No

Secondary Measures

  • Does 17P increase the interval from randomization to delivery?
    • Time Frame: Delivery
      Safety Issue?: No
  • Does 17P reduce neonatal morbidity and mortality?
    • Time Frame: Delivery, Early life
      Safety Issue?: No
  • Does 17P reduce the use of labor inhibition therapy?
    • Time Frame: Duration of pregnancy
      Safety Issue?: No
  • Does 17P reduce the placement of cervical cerclage?
    • Time Frame: Duration of pregnancy
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Nulliparous
  • Cervical length as measured on transvaginal examination < 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
  • Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization

Exclusion Criteria:

  • Multifetal gestation
  • Progesterone treatment after 14 weeks 6 days during current pregnancy
  • Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
  • Amniotic membranes prolapsed beyond external os
  • Preterm rupture of membranes
  • Fetal anomaly
  • Pregnancy without a viable fetus
  • Current or planned cervical cerclage
  • Congenital Mullerian abnormality of the uterus
  • Contraindication to intra-muscular injections
  • Hypertension requiring medication
  • Diabetes managed with insulin or oral hypoglycemic agents
  • DES exposure
  • Cervical surgery such as cold knife conization
  • Planned indicated preterm delivery
  • Participation in another interventional study that influences age at delivery
  • Participation in this trial in a previous pregnancy
  • Prenatal care or delivery planned outside a MFMU Network center

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Overall Clinical Trial Officials and Contacts

William Grobman, MD, MBA Principal Investigator Northwestern University  

Overall Contact: Catherine Y Spong, MD 301-435-6894 spongc@exchange.nih.gov

Additional Information

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00439374

Study ID Number: HD36801 SCAN

ClinicalTrials.gov Identifier: NCT00439374

Health Authority: United States: Federal Government

Click here for more information about the SCAN protocol

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.