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临床试验/NCT05637151
NCT05637151招募中不适用

Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
the neonatal bilirubin values

研究概览

简要总结

Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.

Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group (ICC in pregnant women with ICP)and 50 cases of delayed cord clamping group(DCC in pregnant women with ICP), and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group (ICC in normal pregnant women)and 50 cases of delayed cord clamping group(DCC in normal pregnant women). The bilirubin levels of neonates in each group were compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The pregnant woman is born at a gestational age of 37-40 weeks;
  • The pregnant woman has a single child;
  • Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).

排除标准

  • Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;
  • Insufficiency of vital organ function or complicated tumor;
  • Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.

结局指标

主要结局

the neonatal bilirubin values

时间窗: 2-4 days after birth

the neonatal bilirubin values

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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