Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Not Applicable

Completed

• Conditions: Infant, Premature; Premature Birth
• Interventions: Drug: Intramuscular Progesterone; Drug: Vaginal Progesterone

• Registration Number: NCT00579553
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2020-10-15
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-28
• Last Update Submitted: 2021-04-28
• Results First Posted: 2021-05-19
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular Progesterone	Intramuscular Progesterone	Intramuscular Progesterone
Vaginal Progesterone	Vaginal Progesterone	Vaginal Progesterone

Primary Outcome Measures

Name	Time	Method
Preterm Birth	From 16-20 weeks gestation through preterm delivery	Delivery before 37 weeks gestation.

Secondary Outcome Measures

Name	Time	Method
Mean Neonatal Birth Weight	At delivery
Preterm Birth	From 16-20 weeks gestation through preterm delivery	Delivery below 34 weeks gestation
Gestational Age at Delivery	From 16-20 weeks gestation through preterm delivery	Mean gestational age at delivery

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States