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临床试验/CTRI/2024/09/073451
CTRI/2024/09/073451尚未招募2/3 期

Comparison of early versus delayed cord clamping in preterm deliveries

Dr Madhusmita Shyam1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
380
试验地点
1
主要终点
To assess delayed versus early umbilical cord clamping in mothers undergoing delivery regarding the maternal intra-operative blood loss.

研究概览

简要总结

The third stage of labour is defined as the period of time between the birth of an infant and the complete expulsion of the placenta. The timing of umbilical cord clamping, more specifically, early cord clamping versus Obstetrics delayed cord clamping remains a controversial issue and a subject of continuing debate.

DCC in preterm infants also showed many significant benefits, including establishing better red blood cell volume, decreasing the need for blood transfusion, improving the transitional circulation, and lowering the incidence of intraventricular haemorrhage and necrotizing enterocolitis As a result, the American College of Obstetricians and Gynecologists (ACOG) recommends DCC for at least 30–60 seconds after birth in both preterm and term newborns

DCC presents a number of clinically relevant benefits, with minimal (if any) additive risks, even in healthy infants. These include decreasing neonatal anaemia and iron deficiency, which may have an impact on development. These advantages are also present in populations in which iron deficiency has a relatively low prevalence. Therefore, a universal approach to DCC in the term infant can be justified, given the currently available evidence. Hence, this study aims to evaluate the effect of Early cord clamping and delayed cord clamping during delivery.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Women with singleton pregnancies who delivered at a gestational period of less than 37 weeks were included in the study.

排除标准

  • Women experiencing intra-partum surgical complications such as uterine artery injury, lower segment extension, or IUFD were excluded.
  • Pregnant women suffering from chronic medical conditions like diabetes and hypertension were not part of the study.
  • Cases featuring abnormal placentation, placental abruption, liquor abnormality, or anomalous fetuses were also excluded from the research.

结局指标

主要结局

To assess delayed versus early umbilical cord clamping in mothers undergoing delivery regarding the maternal intra-operative blood loss.

时间窗: From admission of patient to 24 hrs post delivery

次要结局

  • To compare the effect of delayed cord clamping versus early cord clamping regarding the neonatal outcomes.(From admission of patient to delivery of the baby & upto 3 days perioperatively.)

研究者

发起方
Dr Madhusmita Shyam
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Madhusmita Shyam

Silchar medical college and hospital

研究点 (1)

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