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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Preterm labor before 34 weeks gestations
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
a double-blind randomized controlled trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
progesterone 400mg
Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age
干预措施: progesterone 400mg (Drug)
progesterone 200mg plus placebo to progesterone 200 mg
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
干预措施: progesterone 200mg (Drug)
progesterone 200mg plus placebo to progesterone 200 mg
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
干预措施: placebo to progesterone 200mg (Drug)
placebo to progesterone 400 mg
Women received 4 tablets placebo to vaginal progesterone suppositories
干预措施: placebo to progesterone 200mg (Drug)
placebo to progesterone 400 mg
Women received 4 tablets placebo to vaginal progesterone suppositories
干预措施: placebo to progesterone 400mg (Drug)
结局指标
主要结局
Preterm labor before 34 weeks gestations
时间窗: Up to 34 weeks gestational age
Number of patients delivered before 34 weeks gestations
次要结局
- Neonatal respiratory distress syndrome(At birth)
研究者
hany farouk
Principal Investigator
Aswan University Hospital