Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Preterm labor before 35 weeks
研究概览
简要总结
The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.
详细描述
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with singleton pregnancy.
- •History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
- •Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.
排除标准
- •Age < 20 or > 35 years.
- •Congenital uterine malformation.
- •Multifetal pregnancy.
- •Known major fetal structural or chromosomal abnormality.
- •Known allergy or contraindication (relative or absolute) to progesterone therapy.
- •Presence of contraindication to cervical cerclage.
- •Medical conditions complicating pregnancy.
- •Vaginal bleeding.
研究组 & 干预措施
Progesterone group
Vaginal progesterone suppositories will be given
干预措施: Progesterone (Drug)
Cerclage group
Cervical cerclage will be performed.
干预措施: Cervical cerclage (Procedure)
结局指标
主要结局
Preterm labor before 35 weeks
时间窗: Up to 35 weeks gestational age
次要结局
- Delivery before 37 weeks(Up to 37 weeks gestational age)
- Early neonatal death (END)(One month after birth)
- Low birth weight (LBW)(At birth)
- Neonatal respiratory distress syndrome (RDS)(At birth)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University