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Delayed Umbilical Cord Clamping - C-section Pilot

2017年5月24日 更新者:University of California, Davis

Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries

This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to 120 seconds) during elective cesarean deliveries of term infants. The investigators hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this procedure for mothers and babies.

研究概览

地位

完全的

详细说明

Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. The World Health Organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. Recently, the American College of Obstetrics and Gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research".

The objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. We will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. If intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.

研究类型

观察性的

注册 (实际的)

41

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

    • California
      • Sacramento、California、美国、95817
        • University of California Davis Medical Center

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

pregnant women 18 years of age or older that plan on having an elective Cesarean delivery of a term singleton infant.

描述

Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.

Exclusion Criteria:

Pregnant women that do not plan on having a C-section and individuals that are not pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. Adults unable to consent will not be included

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

队列和干预

团体/队列
90 seconds DCC
the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds. Then data will be analyzed and evaluated by DSMB
Two minutes DCC
If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.

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
maternal estimated blood loss (EBL)
大体时间:at delivery (approximately 1 hour duration)

Excessive EBL will be assessed by three measures

  1. clinical assessment by anesthesia/obstetrics after surgery noting amount of blood suctioned and on drapes, to include weighing of drapes at > 800 mL
  2. difference between pre- and post-op hemoglobin levels of > 20% more than that in baseline data
  3. need for transfusion,
at delivery (approximately 1 hour duration)

次要结果测量

结果测量
措施说明
大体时间
neonatal hypothermia
大体时间:at admission (within 30 minutes of birth)
moderate or severe neonatal hypothermia (36.2 rectal or less)
at admission (within 30 minutes of birth)
newborn hemoglobin concentration and hematocrit
大体时间:first day of life (0-24 h of age)
mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
first day of life (0-24 h of age)

其他结果措施

结果测量
措施说明
大体时间
phototherapy
大体时间:< 14 days of age
phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
< 14 days of age
Neonatal intensive care (NICU) 'observation' or admission
大体时间:birth hospitalization (first 72 h of age approximately)
NICU 'observation' during transition or admission will be measured and reason for admission. respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.
birth hospitalization (first 72 h of age approximately)

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2013年10月1日

初级完成 (实际的)

2014年10月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2014年7月22日

首先提交符合 QC 标准的

2014年8月27日

首次发布 (估计)

2014年9月1日

研究记录更新

最后更新发布 (实际的)

2017年5月30日

上次提交的符合 QC 标准的更新

2017年5月24日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • 400656-4

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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