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

Second Affiliated Hospital of Wenzhou Medical University

Status: Enrolling

Conditions: Intrahepatic Cholestasis of Pregnancy

Treatments: Other: clamp time of umbilical

Study type: Interventional

Funder types: Other

Identifiers

NCT05637151

SAHoWMU-CR2022-07-206

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

ICC in pregnant women with ICP

Other group

Description:

Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy

Treatment:

Other: clamp time of umbilical

DCC in pregnant women with ICP

Experimental group

Description:

Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy

Treatment:

Other: clamp time of umbilical

ICC in normal pregnant women

Other group

Description:

Immediate cord clamping group in normal pregnant women

Treatment:

Other: clamp time of umbilical

DCC in normal pregnant women

Experimental group

Description:

Delayed cord clamping group in normal pregnant women

Treatment:

Other: clamp time of umbilical