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临床试验/NCT03640702
NCT03640702已完成不适用

The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20,000
试验地点
1
主要终点
The rate of primary CS.

研究概览

简要总结

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.

The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.

详细描述

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.

The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.

The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Singleton deliveries at or beyond 37 weeks' gestation.

排除标准

  • Non-vertex presentation.
  • Trial of labor after CS.
  • High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
  • Known fetal anomalies and intrauterine fetal demise.

结局指标

主要结局

The rate of primary CS.

时间窗: Between 2011 and 2017.

The rate of primary CS in percentage of the total participants.

次要结局

  • Third-and fourth-degree laceration rate.(Between 2011 and 2017.)
  • The need for blood transfusion.(Between 2011 and 2017.)
  • Post-partum hemorrhage.(Between 2011 and 2017.)
  • The rate of operative vaginal delivery.(Between 2011 and 2017.)
  • Chorioamnionitis rate.(Between 2011 and 2017.)
  • Admission to the NICU.(Between 2011 and 2017.)

研究者

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

Kamel Mattar MD

Principal Investigator

Rambam Health Care Campus

研究点 (1)

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