Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gestational age of delivery
研究概览
简要总结
The aim of this study is to
Determine whether cerclage with vaginal progesterone will:
- Reduce the overall spontaneous preterm birth rate.
- Prolong pregnancy latency.
- Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening.
Research question:
Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening.
Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.
详细描述
A randomized controlled trial The study will be done in Ain Shams University Hospital including women attending antenatal care clinic in Ain Shams University Hospital.
All patients entering the trial will be counselled and will sign a written consent explaining the details of the trial. All the patients included in this study will undergo routine Fetal anomaly scan at 18-24 weeks.Patients with cervical length < 20 mm in routine anomaly scan will :
- Receive vaginal progesterone suppositories 200 mg daily.. (All patients will be continued with vaginal progesterone until 37 completed weeks or until they develop preterm rupture of membrane or preterm delivery).
- Undergo routine follow up of cervical length every 1 to 2 weeks. Patients with progressive shortening of cervical length less than 10 mm during routine follow up, will have the option of continuing vaginal progesterone daily (Progesterone 200 mg vaginal suppositories) alone, or having cervical cerclage placed in addition to daily vaginal progesterone.
In cerclage group: all patients will sign a written consent for approval of cervical cerclage.
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
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged: 20-38 years old.
- •Single living fetus.
- •The patient does not have history of preterm labor (before 37 weeks of gestation)
- •No history of cervical or uterine anomalies.
排除标准
- •Congenital anomalies in the fetus discovered during the follow up.
- •History of spontaneous preterm births.
- •Evidence of imminent delivery, or uterine contractions.
- •Evidence of rupture of membranes, or intra amniotic infection.
- •Intra uterine fetal death.
- •Uterine or cervical anomalies.
研究组 & 干预措施
Vaginal progesterone only
continue on vaginal progesterone only
Cervical cerclage plus vaginal progesterone
cerclage with vaginal progesterone.
干预措施: Cerclage (Procedure)
结局指标
主要结局
Gestational age of delivery
时间窗: <37 weeks
After 37 weeks of pregnancy
次要结局
- New born birth weight(At time of birth)
研究者
Manal Mohammed Fawzy
Principle invistigator
Ain Shams University