Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Completed · Not applicable

Conditions studied: Infant, Premature, Premature Birth

In brief

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.

Key facts

Study ID

NCT00579553

Run by

University of Oklahoma

People needed

174

Starts

2006-10-01

Expected to finish

2011-05-01

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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