Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant, Premature, Premature Birth

Intervention / Treatment
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* Drug: Intramuscular Progesterone
* Drug: Vaginal Progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intramuscular Progesterone<br>Intramuscular Progesterone | Drug: Intramuscular Progesterone<br>* Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P<br>* Other names: 17 alpha hydroxyprogesterone caproate;|
| Experimental: Vaginal Progesterone<br>Vaginal Progesterone | Drug: Vaginal Progesterone<br>* Vaginal Progesterone: 100 mg vaginal suppository daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth | Delivery before 37 weeks gestation. | From 16-20 weeks gestation through preterm delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth | Delivery below 34 weeks gestation | From 16-20 weeks gestation through preterm delivery | 
| Gestational Age at Delivery | Mean gestational age at delivery | From 16-20 weeks gestation through preterm delivery | 
| Mean Neonatal Birth Weight |  | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre Term, Pre Term Birth, Premature Birth, Premature baby, High risk pregnancy, Progesterone, IM Progesterone, Vaginal Progesterone