Official Title: “Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.”

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2013

This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject.

Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Intervention(s) in this Clinical Trial

• Drug: Intramuscular Progesterone
  • Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
• Drug: Vaginal Progesterone
  • Vaginal Progesterone: 100 mg vaginal suppository daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Intramuscular Progesterone
• Experimental: B
  • Vaginal Progesterone

Primary Measures

• To assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.
  • Time Frame: 2 years
    Safety Issue?: No

Inclusion Criteria:

• Singleton pregnancies
• History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)
• Gestational age between 16 weeks 0 days and 20 weeks 6 days.
• Signed consent to participate in the trial

Exclusion Criteria:

• Multiple Gestation
• Prior elective fetal reduction or planned termination
• Known spontaneous reduction to singleton
• Major fetal anomaly or known fetal chromosomal abnormalities
• Progesteone used this pregnancy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

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

Lead Sponsor: University of Oklahoma

Overall Clinical Trial Officials and Contacts

Andrew Elimian, MD Principal Investigator University of Oklahoma  

Overall Contact: Michelle Starkey, RN 405-271-8001 michelle-starkey@ouhsc.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00579553

Study ID Number: Progesterone75,643

ClinicalTrials.gov Identifier: NCT00579553

Health Authority: United States: Food and Drug Administration