Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

Study Overview
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Brief Summary
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The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Detailed Description
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The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome

Official Title
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Evaluation of the Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: a Double-Blind Randomized Controlled Trial

Conditions
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Twin; Pregnancy, Affecting Fetus or Newborn

Intervention / Treatment
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* Drug: progesterone 400mg
* Drug: progesterone 200mg
* Drug: placebo to progesterone 200mg
* Drug: placebo to progesterone 400mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women pregnant in dichorionic twins. Transvaginal sonographic cervical length is <25 mm at 18-22 weeks gestational age. No symptoms, signs or other risk factors for preterm labor. Exclusion Criteria: Known allergy or contraindication (relative or absolute) to progesterone therapy. Monochorionic twins. Known major fetal structural or chromosomal abnormality. Intrauterine death of one fetus or death of both fetuses. Fetal reduction in the current pregnancy. Cervical cerclage in the 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: 18 Years
Maximum Age: 45 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: a double-blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: progesterone 400mg<br>Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age | Drug: progesterone 400mg<br>* Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age<br>* Other names: Active Comparator;|
| Active Comparator: progesterone 200mg plus placebo to progesterone 200 mg<br>Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone | Drug: progesterone 200mg<br>* Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age<br>* Other names: Active Comparator;Drug: placebo to progesterone 200mg<br>* Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age<br>* Other names: Placebo comparator;|
| Placebo Comparator: placebo to progesterone 400 mg<br>Women received 4 tablets placebo to vaginal progesterone suppositories | Drug: placebo to progesterone 200mg<br>* Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age<br>* Other names: Placebo comparator;Drug: placebo to progesterone 400mg<br>* Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age<br>* Other names: placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm labor before 34 weeks gestations | Number of patients delivered before 34 weeks gestations | Up to 34 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal respiratory distress syndrome | Number of neonates develop respiratory distress syndrome | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm birth, Twin gestation, Vaginal progesterone