Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Study Overview
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Brief Summary
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It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy. There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies

Official Title
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Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial

Conditions
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Twin Pregnancy With Antenatal Problem

Intervention / Treatment
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* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primigravidae Twin pregnancies at gestational age 14 week. Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.) Exclusion Criteria: Polyhydramnios Anemia Twins with congenital malformation Twin to twin transfusion Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis Previous cervical surgery High order pregnancy (triples or more)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 400 mg progesterone group<br>Taking 400 mg vaginal progesterone | Drug: Progesterone<br>* Taking prontogest vaginally<br>|
| Active Comparator: 200 mg progesterone group<br>Taking 200 mg vaginal progesterone | Drug: Progesterone<br>* Taking prontogest vaginally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm labor | Number of participants which had preterm labor | Before 37 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical length changes | Cervical length changes in centimeters | Between 14 weeks and 22 weeks gestation | 
| Neonatal ICU admission | Number of neonates required neonatal ICU admission | The first 28 days after delivery | 
| Neonatal mechanical ventilation | Number of neonates required mechanical ventilation | The first 28 days after delivery | 
| Progesterone side effects | The number of patients experiencing progesterone side effects | During one year which is the period from the start of the study till its end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progesterone, Twin pregnancy, Preterm labor