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

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.

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

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

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

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

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