Timing of Umbilical Cord Clamping in Preterm Neonates: A Randomized Controlled Trial
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
- 是
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
Fatma Zaghloul
Lecturer of maternal and newborn health nursing
Cairo University
