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临床试验/NCT03781466
NCT03781466Unknown不适用

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

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm

干预措施: Cervical cerclage (Procedure)

vaginal progesterone

Active Comparator

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

Active Comparator

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

Active Comparator

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

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hany farouk

Principal Investigator

Aswan University Hospital

研究点 (1)

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