17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

Study Overview
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Brief Summary
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Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries. The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: 17 alfa hydroxyprogesterone caproate
* Drug: natural progesterone
* Drug: 17 alfa hydroxyprogesterone caproate
* Drug: vaginal progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week. The subject has a short cervical length defined as 25 mm before 24 weeks gestation. A singleton gestation. Exclusion Criteria: Multifetal pregnancy. The subject has or will have a cervical cerclage in place.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. | Drug: 17 alfa hydroxyprogesterone caproate<br>* weekly injection of 250 mg until 34 weeks gestation<br>|
| Active Comparator: 2<br>previous preterm delivery, treatment with daily vaginal natural progesterone | Drug: natural progesterone<br>* previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.<br>|
| Active Comparator: 3<br>short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. | Drug: 17 alfa hydroxyprogesterone caproate<br>* weekly injection, 250 mg until 34 weeks gestation<br>|
| Active Comparator: 4<br>short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation. | Drug: vaginal progesterone<br>* daily vaginal progesterone 200 mg until 34 weeks gestation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort of use and consequently of that compliance |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm delivery, short cervical length, progesterone