Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation
- Conditions
- Twin; Pregnancy, Affecting Fetus or Newborn
- Interventions
- Drug: placebo to progesterone 200mgDrug: placebo to progesterone 400mg
- Registration Number
- NCT03781674
- Lead Sponsor
- Aswan University Hospital
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description progesterone 200mg plus placebo to progesterone 200 mg progesterone 200mg 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 progesterone 400mg progesterone 400mg Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age progesterone 200mg plus placebo to progesterone 200 mg placebo to progesterone 200mg 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 placebo to progesterone 400 mg placebo to progesterone 200mg Women received 4 tablets placebo to vaginal progesterone suppositories placebo to progesterone 400 mg placebo to progesterone 400mg Women received 4 tablets placebo to vaginal progesterone suppositories
- Primary Outcome Measures
Name Time Method Preterm labor before 34 weeks gestations Up to 34 weeks gestational age Number of patients delivered before 34 weeks gestations
- Secondary Outcome Measures
Name Time Method Neonatal respiratory distress syndrome At birth Number of neonates develop respiratory distress syndrome
Trial Locations
- Locations (1)
Aswan University
🇪🇬Aswan, Egypt