Impact of Standardization on Outcomes Following Cervical Ripening
2026年5月4日 更新者：Sarah Morgan Carpenter、Indiana University
The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening.
Additional outcomes will be evaluated including maternal and fetal outcomes of labor.
研究概览
地位
尚未招聘
条件
详细说明
The goal of this study is to evaluate the impact of standardization of cervical ripening on labor outcomes as well as to evaluate whether different methods of cervical ripening influence labor outcomes The primary outcome will be SVD rate.
Secondary outcomes will include time from admission to delivery, total duration of hospitalization (admission to discharge), operative vaginal delivery rate, incidence of delivery within 24 hours of admission, maximal dose of oxytocin (in mU/min), incidence of tachysystole requiring intervention, incidence of intervention for fetal bradycardia or "non-reassuring fetal status", maternal morbidity (endometritis, 3rd or 4th degree lacerations, hemorrhage >1000mL, blood transfusion, wound separation or infection or readmission), neonatal length of stay>3 days, NICU admission.
研究类型
介入性
注册 (估计的)
1158
阶段
- 阶段2
- 第三阶段
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。
学习地点
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-
Indiana
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Indianapolis、Indiana、美国、46202
- Sidney & Lois Eskenazi Hospital
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接触：
- Sarah M Carpenter, MD
- 电话号码：317-880-2229
- 邮箱：semorgan@iu.edu
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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
是的
描述
Inclusion Criteria:
- Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital
- Willing and able to provide informed consent
- Age ≥18 years old
- Able to read, speak and understand English, Spanish or Haitian Creole
Exclusion Criteria:
- Premature rupture of membranes
- Known chorioamnionitis
- Fetal malpresentation
- Placenta previa
- Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study.
- Prior uterine scar (cesarean delivery or other contraindication to use of prostaglandins)
- Major fetal anomalies known at the time of enrollment that are expected to meaningfully impact labor management
- Multiple gestation
- Allergy to misoprostol or other contraindication to induction of labor or use of misoprostol or cook cervical ripening balloon
- Patient does not require cervical ripening (SBS ≥ 6 or dilation ≥ 4cm)
- Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cervical Ripening with a double balloon catheter only
|
Labor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time.
After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider
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|
实验性的：Cervical ripening with a double balloon catheter plus misoprostol
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The labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time.
After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider.
|
|
有源比较器：Usual-care control group
Cervical ripening will occur using the method chosen by your provider as part of standard clinical care.
This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.
|
Cervical ripening will occur using the method chosen by the provider as part of standard clinical care.
This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.
|
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 |
|---|---|---|
|
SVD rate
大体时间：From enrollment until delivery, up to four days
|
The primary outcome measure for this study is Spontaneous Vaginal Delivery (SVD) rate which is measured as the proportion of patients who deliver vaginally.
|
From enrollment until delivery, up to four days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SVD rate for study arm 1 versus study arm 2 (% difference)
大体时间：From enrollment until delivery, up to four days
|
Comparing (Spontaneous Vaginal Delivery) SVD rates between Cervical Ripening with a double balloon catheter only arm and Cervical ripening with a double balloon catheter plus misoprostol arm.
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From enrollment until delivery, up to four days
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Incidence of delivery within 24 hours of admission
大体时间：Enrollment until delivery, up to four days
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Enrollment until delivery, up to four days
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Incidence of tachysystole requiring intervention
大体时间：Enrollment until study completion, up to 94 days
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Enrollment until study completion, up to 94 days
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Incidence of intervention for fetal bradycardia or "non reassuring fetal status"
大体时间：Enrollment until study completion, up to 94 days
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Enrollment until study completion, up to 94 days
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Rate of Maternal endometritis
大体时间：Enrollment until study completion, up to 94 days
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Enrollment until study completion, up to 94 days
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Composite maternal morbidity
大体时间：From delivery until 30 days after delivery
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measured by % endometritis, 3rd or 4th degree lacerations, QBL >1000mL, intrapartum or postpartum blood transfusion, wound separation or infection, hospital readmission within 30 days after delivery
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From delivery until 30 days after delivery
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neonatal length of stay >3 days
大体时间：From delivery until 3 days post delivery
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From delivery until 3 days post delivery
|
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Rate of NICU admission
大体时间：From delivery until study completion, up to 94 days
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From delivery until study completion, up to 94 days
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Quantitative Blood Loss
大体时间：From delivery until discharge, up to 4 days
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blood loss measured in mL
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From delivery until discharge, up to 4 days
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Time from admission to delivery
大体时间：From admission until delivery, up to four days
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From admission until delivery, up to four days
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Total duration of hospitalization
大体时间：From admission to discharge, up to 8 days
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Total duration of hospitalization measured from admission to discharge
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From admission to discharge, up to 8 days
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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。
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 (估计的)
2026年6月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年4月1日
研究注册日期
首次提交
2026年2月26日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
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.