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临床试验/NCT06000800
NCT06000800已完成不适用

Timing of Umbilical Cord Clamping in Preterm Neonates: A Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
neonatal hematocrit

研究概览

简要总结

Umbilical cord clamping is an important intervention that routinely done for all neonates afterbirth. yet the optimal timing for this intervention remains controversial

详细描述

The study was a randomized controlled trial to assess the effect of timing of umbilical cord clamping on preterm neonatal outcome together The study was conducted in Kasr Al Ainy maternity hospital, Cairo university hospitals which provides free obstetrics and gynecology health services including antepartum, intraparturm, postpartum, and neonatal care for both low risk and high-risk pregnant women A total of 80 pregnant women out of 120 meeting the eligibility criteria were randomly pooled using computer-generated random numbers.

The 80 randomly recruited ladies were randomly allocated using sealed envelopes to a group from 4 equal groups (group A, B, C, and D) of 20 ladies each. Umbilical cord clamping was performed immediately after birth (5 second) in group A, at 30 seconds in group B, at 60 seconds in group C, and at 90 seconds in group D.The trial was unblinded; where the participants and researchers were aware of the group a participant belonged to.

After the study protocol was granted the ethical approval from the research ethical committee of Faculty of Nursing, Cairo University, Egypt, a written informed consent was obtained form mothers of preterm neonate who met the inclusion criteria including the aim, procedure, benefits, and nature of the study .The anonymity and confidentiality of information was assured, and the mothers had the right to withdraw from the study at any time during the study without any effect on the care provided to their preterm neonates.

All study subjects were interviewed using a Structured interview questionnaire to obtain full history to assess participants' demographic data such as age, residence, educational level and occupation, past medical and surgical history, and obstetric history such as gravidity, parity, and current pregnancy antenatal care.

Immediately after birth, neonates in all groups are held 20 cm below the incision level.For neonates in group A,umbilical cord was clamped and cut immediately after birth (5 second); while, neonates in group B, umbilical cord were clamped and cut at 30 seconds. For neonates in group C, umbilical cord was clamped and cut at 60 seconds. And finally, neonates in group D, umbilical cord were clamped and cut at 90 seconds. After cord clamping, all neonates were subject to routine immediate care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

The trial was unblinded; where the participants and researchers were aware of the group a participant belonged to

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • asphyxiated neonates
  • mothers with any medical or obstetrical conditions occurring intrapartum such as hemorrhage, or eclampsia.

结局指标

主要结局

neonatal hematocrit

时间窗: 1st,6th,12th, 24th, and 48th hours

measuring this labs for neonate

neonatal APGAR score

时间窗: 1st, 5th and 10th minutes of life

quick test performed at 1 and 5 minutes after birth to determine the physical condition of the newborn. The five categories assessed are heart rate, respiratory effort, muscle tone, reflex irritability, and color ( score from 8-10 means normal) score from 7-4 moderate asphyxia, from 1-3 sever asphyxia

neonatal hemoglobin

时间窗: 1st,6th,12th, 24th, and 48th hours

measuring this labs for neonate

neonatal bilirubin level test

时间窗: 1st,6th,12th, 24th, and 48th hours

measuring this labs for neonate

neonatal vital signs

时间窗: 1st,6th,12th, 24th, and 48th hours

respiration

次要结局

  • blood glucose(1st,6th,12th, 24th, and 48th hours)
  • oxygen saturation(1st,6th,12th, 24th, and 48th hours)

研究者

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

Fatma Zaghloul

Lecturer of maternal and newborn health nursing

Cairo University

研究点 (2)

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