跳至主要内容
临床试验/CTRI/2024/07/070137
CTRI/2024/07/070137尚未招募不适用

A Randomized controlled trial to compare the feto-maternal outcomes after physiologic cord clamping vs delayed cord clamping at one minute in women undergoing elective caesarean section at term

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Evaluate the effect of physiologic cord clamping versus delayed cord clamping at 1 minute on the amount of postpartum haemorrhage .

研究概览

简要总结

Umbilical cord clamping is a pivotal step in the third stage of labor which serves to separate the newborn from the placenta. The timing of this procedure has become a global point of contention. Although several reputable medical organizations, including the American College of Obstetrics and Gynaecologists (ACOG) (9), American Academy of Paediatrics (AAP) [10], European Resuscitation Council [11], National Institute for Health and Care Excellence (NICE) [12], Society of Obstetrician and Gynaecologists of Canada [13], and the World Health Organization [14], advocate for Delayed Cord Clamping (DCC), there is a lack of consistency in its definition. The recommended duration of DCC in these society guidelines ranges from 30 seconds to 5 minutes or even longer, or until umbilical cord pulsation ceases. Surveys on DCC have also highlighted significant variations in its clinical implementation. The World Health Organization (WHO) categorizes early cord clamping as the clamping done within the initial 60 seconds after birth. Conversely, delayed cord clamping occurs between 1 to 3 minutes after birth or when the umbilical cord pulsations cease [1, 2]. In its 2014 Guideline on delayed cord clamping, WHO recommends a delay of at least 60 seconds before clamping, even when positive pressure ventilation is necessary, for both term and preterm infants [1]. This protocol underscores the significance of appropriate timing in ensuring the well-being of newborns during this crucial stage of childbirth. Although most of the leading scientific organisations of obstetrics and neonatology recommend delayed cord clamping, the definition of DCC used vary from one scientific society to another. While most of them recommend delaying clamping the cord to more than 60 seconds (4), some consider that it can be delayed up to 5 minutes if the new born is vigorous and p[laced in skin to skin contact with the mother (5).  The Pan American Health Organization (regional office of the World Health Organization) recommends “The optimal time to clamp the umbilical cord for all infants regardless of gestational age or fetal weight is when the circulation in the cord has ceased, and the cord is flat and pulseless (approximately 3 minutes or more after birth) (6).

The advantages of delayed cord clamping, after the delivery of fetus have been widely documented in literature. Nevertheless, the potential impacts on maternal health remain uncertain, warranting a comprehensive investigation into its consequences. To date, only  few studies in the existing literature have focused on maternal mortality and hemorrhage as primary outcomes. Thus, there is a pressing need for additional research to thoroughly evaluate both maternal and neonatal outcomes following the shift in active management during the third stage of delivery (1-3). Allowing the baby to remain attached to the placenta via the umbilical cord after delivery does not pose any negative consequences for both the mother and the newborn. It’s important to recognize that in Western cultures until the 17th century, the practice of clamping and cutting the cord used to occur after the placenta was delivered. The shift to clamping before the placenta’s birth primarily happened for the sake of convenience [7, 8]. Therefore, the present study is planned to compare two different intervals of delayed cord clamping, one after 60 seconds, and second being physiological clamping of the cord after the delivery of placenta by neonatologist, after complete cessation of placental transfusion, on feto-maternal outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients, aged 18-45 years, scheduled to undergo a planned/elective caesarean section in AIIMS Bibinagar for a routine indication.
  • Singleton pregnancy
  • Gestational age of the fetus is more than 37 weeks
  • No e/o fetal growth restriction or uteroplacental insufficiency.

排除标准

  • Patients refusing to give consent to participate in the study
  • Patients undergoing emergency caesarean section
  • Women with pregnancy carrying fetus with congenital anomaly
  • Patients with any cause of high-risk pregnancy,
  • Any other indication mandating immediate cord clamping, like placenta praevia, Rh incompatibility.
  • Neonates with any signs suggestive of distress, or not crying immediately after birth.

结局指标

主要结局

Evaluate the effect of physiologic cord clamping versus delayed cord clamping at 1 minute on the amount of postpartum haemorrhage .

时间窗: At the time of delivery

次要结局

  • Determine the impact of physiologic cord clamping versus delayed cord clamping at one minute on neonatal admissions due to any of the followings(• Respiratory distress since birth (or))
  • Duration of third stage of labour and total surgical time
  • Serum ferritin levels of the baby(6 months of life)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mishu Mangla

All India Institute of Medical Sciences, Bibinagar, Hyderabad

研究点 (1)

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