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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05637151

Enrollment

200

Registered

2022-12-05

Start date

2022-12-01

Completion date

2024-06-01

Last updated

2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

Intrahepatic cholestasis during pregnancy, neonatal bilirubin, bilirubin, ICP, neonatal jaundice

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.

Interventions

OTHERclamp time of umbilical

The umbilical cord was clamped immediately or late for more than 30s

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
the neonatal bilirubin values	2-4 days after birth	the neonatal bilirubin values

Countries

China

Contacts

Primary ContactYing Hua

wzfeyhy1015@126.com+8613676403165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026