Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Preterm labor before 34 weeks
研究概览
简要总结
The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
详细描述
There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination 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
- None
盲法说明
A randomized clinical trial open label
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 16-20 weeks gestational age.
- •No symptoms, signs or other risk factors for preterm labor
排除标准
- •Age < 18 years or > 45 years.
- •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.
- •Medical conditions that may lead to preterm delivery.
- •Rupture of membranes.
- •Vaginal bleeding
研究组 & 干预措施
Cervical cerclage
Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm
干预措施: Cervical cerclage (Procedure)
vaginal progesterone
Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks
干预措施: vaginal progesterone (Drug)
Cervical cerclage plus vaginal progesterone
Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks
干预措施: Cervical cerclage (Procedure)
Cervical cerclage plus vaginal progesterone
Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks
干预措施: vaginal progesterone (Drug)
结局指标
主要结局
Preterm labor before 34 weeks
时间窗: Up to 34 weeks gestational age
Number of patients with preterm birth before 34 weeks gestations
次要结局
- Neonatal respiratory distress syndrome(At birth)
- Early neonatal death(within one month postpartum)
研究者
hany farouk
Principal Investigator
Aswan University Hospital
