Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 22, 2023
February 1, 2023
1 year
November 28, 2022
February 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the neonatal bilirubin values
the neonatal bilirubin values
2-4 days after birth
Study Arms (4)
ICC in pregnant women with ICP
OTHERImmediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
DCC in pregnant women with ICP
EXPERIMENTALDelayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
ICC in normal pregnant women
OTHERImmediate cord clamping group in normal pregnant women
DCC in normal pregnant women
EXPERIMENTALDelayed cord clamping group in normal pregnant women
Interventions
The umbilical cord was clamped immediately or late for more than 30s
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying Hua
Second Affiliated Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 5, 2022
Study Start
December 1, 2022
Primary Completion
December 1, 2023
Study Completion
June 1, 2024
Last Updated
February 22, 2023
Record last verified: 2023-02