Comparing IM vs. Vaginal Progesterone for Pre-term Birth

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oklahoma
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate; Progesterone

Criteria

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