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临床试验/NCT06491368
NCT06491368已完成不适用

Optimal Interval Between Consecutive Cesarean Sections: A Comparative Study on Maternal and Neonatal Outcomes

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2024年7月10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
入组人数
201
试验地点
2
主要终点
Intraoperative complications

研究概览

简要总结

The goal of this observational study is to determine the best time interval between consecutive cesarean sections and compare maternal and neonatal outcomes in women with a history of previous cesarean sections. The main questions it aims to answer are:

  • What is the optimal time interval between consecutive cesarean sections for minimizing maternal intraoperative complications, blood transfusions, and intra- and postoperative bleeding?
  • What are the differences in fetal and neonatal outcomes based on different time intervals between cesarean sections?

Participants will be divided into five subgroups based on the time interval since their last cesarean section: 0-12 months, 12-24 months, 25-36 months, 37-48 months, and more than 48 months. Each participant will undergo an elective cesarean section and provide data on maternal and neonatal outcomes.

Researchers will compare these subgroups to see if varying time intervals between consecutive cesarean sections affect maternal and neonatal outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 20-42 years.
  • Full-term pregnant women more than 37 weeks gestation.
  • Women with a history of at least one previous cesarean section, planning an elective repeated cesarean section.

排除标准

  • Women with contraindications to cesarean section
  • Those with emergency indications
  • Multiple pregnancies
  • Pre-existing maternal or fetal conditions affecting outcomes.

研究组 & 干预措施

Less than 18 months

This group consists of women who have had their previous cesarean section less than 12 months before the current scheduled elective cesarean section.

干预措施: Cesarean Delivery (Procedure)

18-24 months

This group includes women whose previous cesarean section was 12 to 24 months before their current scheduled elective cesarean section.

干预措施: Cesarean Delivery (Procedure)

25-36 months

This group is comprised of women who had their last cesarean section between 25 and 36 months prior to the current scheduled elective cesarean section.

干预措施: Cesarean Delivery (Procedure)

37-48 months

This group consists of women whose previous cesarean section occurred 37 to 48 months before the current scheduled elective cesarean section.

干预措施: Cesarean Delivery (Procedure)

More than 48 months

This group includes women who had their last cesarean section more than 48 months before their current scheduled elective cesarean section.

干预措施: Cesarean Delivery (Procedure)

结局指标

主要结局

Intraoperative complications

时间窗: Withen the surgery.

Occurrences of injuries to the bladder or bowel during surgery, injury of uterine artery, extension of uterine incision.

次要结局

  • Fetal distress(during and 24 hours after the surgery.)
  • Blood transfusions(withen the surgery and up to 24 hours after the sutgery.)
  • Neonatal Apgar scores(5 minutes after birth.)
  • NICU admissions(during and 24 hours after the surgery.)
  • Intraoperative and postoperative bleeding (quantify blood loss(withen the surgery and up to 24 hours after the sutgery.)
  • ICU admissions(1 week after the surgery.)
  • Neonatal morbidity and mortality(during and 2 weeks after the surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

Lecturer of Obstetrics and Gynecology

Al-Azhar University

研究点 (2)

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