Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Spontaneous preterm birth
研究概览
简要总结
A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.
详细描述
This is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. Two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •all twin pregnancies
- •cervical length less than 30mm
排除标准
- •Twin to twin transfusion syndrome
- •Stillbirth
- •congenital anomaly in one of the fetuses
- •previous cervical trauma or surgery
- •cervical cerclage in current pregnancy
- •premature labour with or without rupture of membranes
- •severe vaginal discharge
- •acute vaginitis or cervicitis
研究组 & 干预措施
Vaginal progestogen
200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation.
干预措施: Micronised vaginal progesterone (Drug)
Vaginal pessary
Vaginal pessary with an internal diameter size of 32 or 35 mm will be inserted at the time of recruitment and kept until 34 weeks gestation.
干预措施: Vaginal pessary (Device)
结局指标
主要结局
Spontaneous preterm birth
时间窗: Through study completion up to 37 weeks
Mean gestational age at delivery in weeks
次要结局
- Maternal age(Pre-intervention)
- Race(Pre-intervention)
- Maternal body mass index(Pre-intervention)
- Parity(Pre-intervention)
- Type of twin pregnancy(Pre-intervention)
- Type of conception(Pre-intervention)
- Gestational age at recruitment(Pre-intervention)
- Gestational age at commencement of treatment(Pre-intervention)
- Cervical length before commencement of treatment(Pre-intervention)
- Vaginal infection(Pre-intervention)
- Previous miscarriages(Pre-intervention)
- Pre-existing medical disorders(Pre-intervention)
- Previous spontaneous preterm birth(Pre-intervention)
- Antenatal complications(Through study completion up to 37 weeks)
- Fetal complications(Through study completion up to 37 weeks)
- Mode of delivery(Through study completion up to 37 weeks)
- Intrapartum complications(Throughout labour up to delivery of the neonate)
- Postpartum complications(Through delivery of neonate up to 42 days after delivery)
- Total blood loss(Through delivery of neonate up to 42 days after delivery)
- Birth weight(Immediately after birth of neonate)
- Neonatal complications(Immediately after birth up to 30 days)
- Apgar score(Immediately after birth of neonate)
- Anthropometry assessment of neonates(Immediately after birth of neonate)
- Duration in neonatal intensive care unit(Through neonatal intensive care unit stay up to discharge (approximately 30 days))
- Neonatal intensive care unit admission(Immediately after birth of neonate up to discharge (approximately 30 days))
研究者
Rahana Abd Rahman
Co-primary investigator
National University of Malaysia