The Effect of Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- postpartum 6th month scar thickness
研究概览
简要总结
The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters.
详细描述
A randomized double-blind clinical trial comparing cervical dilatation during caesarean section to no intervention.
- Study participants and sample size This study will include pregnant women with a singleton fetus at term ≥37 weeks of gestation and will be scheduled for elective caesarean section. Eligible participants will be allocated either to the study group (women with intraoperative cervical dilatation) or the control group (women with no intraoperative cervical dilatation).
- Types of interventions Mechanical dilatation of the cervix using a finger, sponge forceps during non-labour caesarean section ***Randomization and Allocation A statistician prepared a computer-generated random tableand placed the group allocation in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and numbering will be performed by two independent doctors other than the investigator.
Patients are allocated to either study group (cervical dilatation) or control group (no cervical dilatation). Allocation will be never changed after opening the envelopes. All patients are blinded to the allocation to avoid bias.
**Neither the investigator nor the outcome assessor following up the patient postoperatively are aware whether the patient had undergone cervical dilation during the cesarean section or not (double-blinding). Randomization coding tables will be hidden from the investigator till the end of the study.
Group I (dilation group): in which mechanical cervical dilatation will be done.
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
- Double (Participant, Investigator)
盲法说明
A statistician prepared a computer-generated random tableand placed the group allocation in serially numbered closed opaque envelopes in a 1:1 ratio. Packing, sealing and numbering will be performed by two independent doctors other than the investigator.
Patients are allocated to either study group (cervical dilatation) or control group (no cervical dilatation). Allocation will be never changed after opening the envelopes. All patients are blinded to the allocation to avoid bias.
Neither the investigator nor the outcome assessor following up the patient postoperatively are aware whether the patient had undergone cervical dilation during the cesarean section or not (double-blinding). Randomization coding tables will be hidden from the investigator till the end of the study.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective Cs (primary or repeated CS)
排除标准
- •Medical or obstetric conditions that may put them at risk for uterine atony and postpartum hemorrhage and infection, such as:
- •Emergency Cesarean section
- •Chorioamnionitis.
- •Preterm caesarean section.
- •Multiple gestations.
- •Fever during admission.
- •Rupture of membranes.
结局指标
主要结局
postpartum 6th month scar thickness
时间窗: 6 months after delivery
measure the thickness of the residual myometrial tissue (RMT) in mm by transvaginal ultrsound
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University