Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

Study Overview
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Brief Summary
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To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Detailed Description
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Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Official Title
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Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

Conditions
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Premature Labour

Intervention / Treatment
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* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women pregnant in dichorionic twins. Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age. No symptoms, signs or other risk factors for preterm labor. Exclusion Criteria: Age < 20 years or > 35 years. Known allergy or contraindication (relative or absolute) to progesterone therapy. Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI). Monochorionic twins. Known major fetal structural or chromosomal abnormality. Intrauterine death of one fetus or death of both fetuses. Fetal reduction in current pregnancy. Cervical cerclage in current pregnancy. Medical conditions that may lead to preterm delivery. Rupture of membranes. Vaginal bleeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- |
| Active Comparator: Progesterone group<br>Women received vaginal progesterone suppositories | Drug: Progesterone<br>* Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age<br>* Other names: Cyclogest;|
| No Intervention: No treatment group<br>Women received no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm labor before 34 weeks |  | Up to 34 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal respiratory distress syndrome (RDS) |  | At birth | 
| Early neonatal death (END). |  | One month after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Twins, Preterm labor, Progesterone, Short cervix