The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
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.
研究概览
详细说明
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).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Haifa、以色列
- Rambam Health Care Campus
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
1. Singleton deliveries at or beyond 37 weeks' gestation.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
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To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The rate of primary CS.
大体时间：Between 2011 and 2017.
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The rate of primary CS in percentage of the total participants.
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Between 2011 and 2017.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The rate of operative vaginal delivery.
大体时间：Between 2011 and 2017.
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The rate of operative vaginal delivery in percentage of the total participants.
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Between 2011 and 2017.
|
|
Post-partum hemorrhage.
大体时间：Between 2011 and 2017.
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Post-partum hemorrhage as estimated in liters.
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Between 2011 and 2017.
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The need for blood transfusion.
大体时间：Between 2011 and 2017.
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Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage.
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Between 2011 and 2017.
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Third-and fourth-degree laceration rate.
大体时间：Between 2011 and 2017.
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Third-and fourth-degree laceration rate of the total number of participants.
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Between 2011 and 2017.
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Chorioamnionitis rate.
大体时间：Between 2011 and 2017.
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Chorioamnionitis rate in percentage of the total participants.
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Between 2011 and 2017.
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Admission to the NICU.
大体时间：Between 2011 and 2017.
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Admission to the NICU in percentage of the total participants.
|
Between 2011 and 2017.
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合作者和调查者
调查人员
- 首席研究员：Kamel Mattar, MD、Principal Investigator
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0258-17-RMB
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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