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

Intrahepatic Cholestasis of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637151
• Other study ID #: SAHoWMU-CR2022-07-206
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Ying Hua
• Phone: +8613676403165
• Email: wzfeyhy1015[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Intrahepatic
• Intrahepatic Cholestasis of Pregnancy
• Pregnancy Complications

Intervention

Other:
• clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s

Locations

Country	Name	City	State
China	department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the neonatal bilirubin values	the neonatal bilirubin values	2-4 days after birth