Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

Study Overview
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Brief Summary
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This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

Detailed Description
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The objectives of this study is 1) To compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) To compare the cost-benefit, adverse effects and patient preference of two different regimens of progesterone therapy. Design: Multi-center, randomized, open-label trial

Official Title
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A Multicenter, Randomized, Open-label, Investigator Initiated Trial of Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

Conditions
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Premature Birth

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With a history of prior spontaneous preterm birth or short cervix length Spontaneous preterm birth: preterm birth <37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (PPROM) Short Cervix length : cervix length <25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation Exclusion Criteria: Multiple gestations Major congenital anomalies Elective prophylactic cervical cerclage <16 weeks of gestation during current pregnancy Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction Diabetes, hypertension, other severe medical diseases

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal progesterone<br>Vaginal progesterone(Utrogestan)200mg/day, during 14 21 weeks. | Drug: Vaginal progesterone<br>* micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes<br>* Other names: Utrogestan;|
| Active Comparator: Intramuscular progesterone<br>Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14 21 weeks. | Drug: Intramuscular progesterone<br>* hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes<br>* Other names: Progesterone Depot Jenapharm Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth Rate before 37 weeks of gestation |  | from study enrollment to maximum 37 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Birth Rate before 34 weeks of gestation |  | from study enrollment to maximum 34 weeks of gestation | 
| Preterm Birth Rate before 28 weeks of gestation |  | from study enrollment to maximum 28 weeks of gestation | 
| Result of birth(rate of death, weight, cause of hospitalization to NICU) |  | from study enrollment to maximum 37 weeks of gestation | 
| Any complications occurred to newborn and mother |  | from study enrollment to maximum 37 weeks of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Birth, progesterone