Integrated Intrapartum Supportive Care and Pushing Strategies in Women Receiving Low-Dose Epidural Analgesia
2026年6月17日 更新者：Wan-Lin Pan、National Taipei University of Nursing and Health Sciences
Integrated Intrapartum Supportive Care Combined With Different Pushing Strategies Among Women Receiving Low-Dose Epidural Analgesia: A Three-Arm Non-Randomized Quasi-Experimental Study
This prospective, three-arm, non-randomized quasi-experimental study aims to evaluate integrated intrapartum supportive care combined with different pushing strategies among women at 37-42 weeks of gestation who receive low-dose epidural analgesia.
Participants receive integrated intrapartum supportive care combined with spontaneous pushing, integrated intrapartum supportive care combined with immediate pushing, or routine intrapartum care combined with immediate pushing.
The primary outcomes are the durations of the first and second stages of labor.
Secondary outcomes include mode of birth, obstetric interventions, maternal outcomes, and neonatal outcomes.
研究概览
地位
招聘中
详细说明
Participants are enrolled into one of three predefined care groups: (1) integrated intrapartum supportive care combined with spontaneous pushing (IC-SP), (2) integrated intrapartum supportive care combined with immediate pushing (IC-IP), or (3) routine intrapartum care combined with immediate pushing (RC-IP).
Group allocation is determined prospectively according to the attending physician's established clinical practice.
The RC-IP group receives the hospital's usual intrapartum care.
Allocation is determined before implementation of the intervention and is not based on labor outcomes.
研究类型
介入性
注册 (估计的)
159
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Wan-Lin Pan, PhD
- 电话号码：+886-2-2822-7101 ext. 7101
- 邮箱：wanlimp@gmail.com
学习地点
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Taipei、台湾、10556
- 招聘中
- Taiwan Adventist Hospital
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接触：
- Wan-Lin Pan
- 电话号码：0933710737
- 邮箱：wanlimp@gmail.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:low-risk pregnant women aged 18 years or older with a singleton, term pregnancy (37-42 weeks), spontaneous labor onset, and planning to receive low-dose epidural analgesia.
Exclusion Criteria: Exclusion Criteria: multiple gestation, non-cephalic presentation, known major fetal anomalies, planned cesarean birth, contraindications to vaginal birth, contraindications to maternal mobility or epidural analgesia, or inability to provide informed consent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Integrated Care with Spontaneous Pushing
Integrated Care with Spontaneous Pushing Group
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Participants receive the integrated intrapartum supportive care program during the first stage of labor.
During the second stage, participants are encouraged to begin pushing in response to their spontaneous urge to push rather than routinely initiating pushing immediately after full cervical dilation.
The pushing strategy is implemented by the attending clinical care team according to the predefined group protocol.
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实验性的：Integrated Care with Immediate Pushing
Integrated Care with Immediate Pushing Group
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Integrated Care with Immediate Pushing Group: Participants receive an integrated intrapartum care package that includes continuous labor support and active birth positioning.
Once full cervical dilation is achieved, participants are instructed to begin pushing immediately, regardless of the presence or absence of an urge to push.
This directive approach to second-stage labor is guided by midwives or obstetric staff.
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有源比较器：Standard Routine Care
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Participants receive routine intrapartum care according to institutional clinical practice.
Supportive measures and position changes may be provided according to maternal needs and clinical judgment, but participants do not receive the structured multicomponent integrated intrapartum supportive care program.
During the second stage of labor, pushing begins after full cervical dilation according to the attending clinical team's immediate pushing practice.
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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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Duration of the first and second stages of labor
大体时间：From the onset of active labor to the delivery of the fetus.
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The duration of the first stage of labor is defined as the time interval from the onset of active labor-marked by regular, painful uterine contractions and cervical dilation of ≥6 cm-until full cervical dilation (10 cm).
The duration of the second stage of labor is defined as the time from full cervical dilation to the complete delivery of the fetus.
Labor durations will be recorded in minutes based on partograph entries and electronic medical records, with all timings verified by attending midwives or obstetric care providers to ensure accuracy.
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From the onset of active labor to the delivery of the fetus.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Caesarean Section Rate
大体时间：During labor and delivery
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The proportion of enrolled participants who undergo unplanned cesarean birth during labor or delivery.
Indications for cesarean birth will be extracted from the medical record.
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During labor and delivery
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Instrumental Vaginal Delivery Rate
大体时间：During delivery
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The proportion of participants who undergo instrumental vaginal delivery using forceps or vacuum extraction.
The use of instruments will be recorded based on delivery records, and indications will be documented when available.
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During delivery
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Augmentation Rate
大体时间：During labor
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The proportion of participants who receive augmentation of labor after spontaneous onset.
Administration details (timing, dosage, indication) will be obtained from medical records and partographs.
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During labor
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wan-Lin Pan, PhD、National Taipei University of Nursing and Health Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年6月10日
初级完成 (估计的)
2026年7月31日
研究完成 (估计的)
2026年7月31日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2024E02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
This study does not plan to share individual participant data.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.