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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intrahepatic Cholestasis of Pregnancy

Intervention / Treatment
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* Other: clamp time of umbilical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ICC in pregnant women with ICP<br>Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy | Other: clamp time of umbilical<br>* The umbilical cord was clamped immediately or late for more than 30s<br>|
| Experimental: DCC in pregnant women with ICP<br>Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy | Other: clamp time of umbilical<br>* The umbilical cord was clamped immediately or late for more than 30s<br>|
| Other: ICC in normal pregnant women<br>Immediate cord clamping group in normal pregnant women | Other: clamp time of umbilical<br>* The umbilical cord was clamped immediately or late for more than 30s<br>|
| Experimental: DCC in normal pregnant women<br>Delayed cord clamping group in normal pregnant women | Other: clamp time of umbilical<br>* The umbilical cord was clamped immediately or late for more than 30s<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the neonatal bilirubin values | the neonatal bilirubin values | 2-4 days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrahepatic cholestasis during pregnancy, neonatal bilirubin, bilirubin, ICP, neonatal jaundice