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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05637151

Collaborator

(none)

200

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholestasis of Pregnancy	Other: clamp time of umbilical	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Jun 20, 2024

Anticipated Study Completion Date :

Dec 20, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

the neonatal bilirubin values [2-4 days after birth]
the neonatal bilirubin values

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.