Passive Descent in Obese Nulliparous Gravidae
2014年3月5日 更新者:Alisse Hauspurg、Women and Infants Hospital of Rhode Island
Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?
Obesity rates in reproductive aged women in the United States are rising.
It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section.
Recent studies have also shown an increased rate of cesarean section in obese women, adding to the already elevated rate of complications and adverse outcomes.
Given the increased a priori risk for obese patients, it is vital that the investigators reexamine management practices routinely used for normal weight women in this specific high-risk population.
Passive descent has been shown to increase the spontaneous vaginal delivery rate in non-obese women; however, high quality studies have never been performed in obese women.
the investigators hypothesize that passive descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with regional anesthesia.
This study will randomize women to passive descent for ninety minutes or active pushing upon entry into the second stage.
Further, given that passive descent is widely accepted in the midwifery literature and clinical practice, the investigators anticipate that a high-quality study in the physician literature could increase the dialogue between practitioners and lead to development of best practices in this high-risk population.
研究概览
地位
未知
干预/治疗
研究类型
介入性
注册 (预期的)
540
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。
学习地点
-
-
Rhode Island
-
Providence、Rhode Island、美国、02905
- Women and Infants Hospital
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不适用
有资格学习的性别
女性
描述
Inclusion Criteria:
- Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)] greater than or equal to 30 as determined at the time of admission to labor and delivery
- Regional anesthesia
- Nulliparous (defined as no deliveries after 20 weeks gestation)
- Gestational age of 37 0/7 weeks and greater
- Singleton Pregnancy
Exclusion Criteria:
- Body mass index (BMI) calculated as weight (kg)/ [height (m2)] less than 30 as determined at the time of admission to labor and delivery
- No regional anesthesia
- Multiparous
- Gestational age of less than 37 0/7 weeks
- Multiple gestations
- Maternal fever prior to second stage
- Severe fetal anomalies (incompatible with life)
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Immediate Pushing
Patient's will begin to push when they are determined to be completely dilated.
|
|
|
实验性的:Passive Descent
Patient's will wait 90 minutes prior to begin pushing
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Rate of spontaneous vaginal delivery
大体时间:At delivery
|
At delivery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of infections (defined as fever and / or antibiotic initiation)
大体时间:participants will be followed for the duration of hospital stay, an expected average of 3 days
|
participants will be followed for the duration of hospital stay, an expected average of 3 days
|
|
|
Rate of Third and Fourth Degree Lacerations
大体时间:At delivery
|
At delivery
|
|
|
Rate of Postpartum Hemorrhage
大体时间:At delivery
|
At delivery
|
|
|
Neonatal Outcomes
大体时间:At delivery
|
|
At delivery
|
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:Alisse Hauspurg, MD、Women & Infant's Hospital
- 研究主任:Erika Werner, MD、Women & Infant's Hospital
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
初级完成 (预期的)
2015年6月1日
研究注册日期
首次提交
2014年3月3日
首先提交符合 QC 标准的
2014年3月5日
首次发布 (估计)
2014年3月6日
研究记录更新
最后更新发布 (估计)
2014年3月6日
上次提交的符合 QC 标准的更新
2014年3月5日
最后验证
2014年3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.