Delayed Umbilical Cord Clamping - C-section Pilot
Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries
研究概览
地位
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
注册 (实际的)
联系人和位置
学习地点
-
-
California
-
Sacramento、California、美国、95817
- University of California Davis Medical Center
-
-
参与标准
资格标准
适合学习的年龄
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: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
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
|
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
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
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 (估计)
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
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.