Comparing IM vs. Vaginal Progesterone for Pre-term Birth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00579553
First received: December 18, 2007
Last updated: May 20, 2014
Last verified: May 2014

December 18, 2007
May 20, 2014
October 2006
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00579553 on ClinicalTrials.gov Archive Site
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Comparing IM vs. Vaginal Progesterone for Pre-term Birth
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infant, Premature
  • Premature Birth
  • Drug: Intramuscular Progesterone
    Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
    Other Name: 17 alpha hydroxyprogesterone caproate
  • Drug: Vaginal Progesterone
    Vaginal Progesterone: 100 mg vaginal suppository daily
    Other Name: Vaginal Progesterone
  • Active Comparator: A
    Intramuscular Progesterone
    Intervention: Drug: Intramuscular Progesterone
  • Experimental: B
    Vaginal Progesterone
    Intervention: Drug: Vaginal Progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
264
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00579553
Progesterone75,643
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Andrew Elimian, MD University of Oklahoma
University of Oklahoma
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP