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临床试验/NCT01924572
NCT01924572已完成不适用

Placental Transfusion in Term Infants Placed Skin-to-Skin: A Pilot Controlled Trial

University of Rhode Island2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Placental Residual Blood volume

研究概览

简要总结

The proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. However, the best way to get the most blood to the baby is not known. The practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.

详细描述

The proposed study is a pilot prospective controlled trial to measure the placental residual blood volume after varying cord clamping protocols when the infants are placed skin-to-skin on the maternal abdomen. The study assessed compliance of the providers with the different protocols. Placental transfusion (PT) has been shown to increase infant body iron stores at 6 months of age without increasing adverse outcomes. However, the optimal protocol to achieve adequate placental transfusion is not known. The practice of cord clamping at birth is not uniform among obstetrical providers because adequate evidence to support early or late cord clamping has been lacking.

Women were eligible to enroll in the study if they had no pregnancy complications, did not smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks. Women were enrolled prenatally on the labor and delivery unit. At birth, women were assigned to one of four cord clamping/milking groups. A cohort of infants with immediate cord clamping serves as reference group. Infants had blood samples drawn with the routine newborn screening blood samples done at 36 to 48 hours. Information on infant health and feeding was completed through an in-hospital visit to the mother and by home visit at two weeks of age. The primary outcome measures were placental residual blood volume and compliance with the various assigned cord clamping protocols. It was expected that infants with delayed cord clamping or cord milking would have less placental residual blood volume and that most providers would comply with the various random assignments.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Women with normal pregnancy and presented at the labor room at 38-416/7 weeks for vaginal delivery; Intention to breast feed the babies; Consent for a follow up at 2 weeks of age

排除标准

  • Abnormal pregnancy: Gestational or pre-existing diabetes, smoking and substance abuse, pre-eclampsia, fetal abnormality

结局指标

主要结局

Placental Residual Blood volume

时间窗: obtained immediately after birth

Blood remaining in the placenta after cord clamping measured by drainage

次要结局

  • Infant hematocrit and hemoglobin(at 36 to 48 hours of age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith S Mercer

Professor, Principal Investigator

University of Rhode Island

研究点 (2)

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