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临床试验/NCT06103071
NCT06103071已完成不适用

Effectiveness of Membrane Sweeping on Successful Initiation of Labor and Subsequent Vaginal Birth in Patients With Previous One Cesarean Section.

HITEC-Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2023年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
384
试验地点
1
主要终点
Number of Participants With Onset of Labor by 40 Weeks

研究概览

简要总结

In Pakistan rate of child birth through cesarean section increased from 3.2% in 1992 to 22% in 2018 .Due to increasing rates of cesarean sections and associated morbidity the investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. This is a randomized controlled trial. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

详细描述

World Health Organization suggests that ideally cesarean section rate should not be more than 10% to 15%. The investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. It is reported in literature that there is no significant increase risk to maternal or neonatal outcome with membrane sweeping. The rationale of the study was to compare the effect of membrane sweeping with no sweeping in the successful onset of labor in patients with one previous Cesarean Section so that the investigators can reduce the cesarean section rate. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

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 (Participant)

盲法说明

lottery method for selection

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

  • 1. Women willing for vaginal birth after lower segment cesarean section from 37 weeks of gestation to 40 weeks.
  • 2. Previous one caesarean section for non-recurrent cause
  • Singleton pregnancy
  • Cephalic presentation

排除标准

  • Previous uterine rupture
  • Major degree placenta previa
  • Any medical disorder like PIH, diabetes
  • Bad obstetrics history

研究组 & 干预措施

Sweeping group

Active Comparator

Sweeping group include patients in which membrane sweeping started from 37 weeks and performed weekly till 40 weeks. Intervention is the sweeping of membranes from 37 weeks of gestational amenorrhea.

干预措施: Sweeping of membranes (Procedure)

Non sweeping group

No Intervention

Non sweeping group include patients in which no sweeping of membranes done. No intervention done.

结局指标

主要结局

Number of Participants With Onset of Labor by 40 Weeks

时间窗: Primary outcome include number of participants that had onset of labour from enrollment upto 40 weeks gestation

次要结局

  • Number of Participants Having Successful Vaginal Delivery(4 weeks)

研究者

发起方
HITEC-Institute of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nida Khan

Principal investigator

HITEC-Institute of Medical Sciences

研究点 (1)

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