Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
NCT ID: NCT05637151
Last Updated: 2023-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-12-01
2024-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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ICC in pregnant women with ICP
Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
DCC in pregnant women with ICP
Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
ICC in normal pregnant women
Immediate cord clamping group in normal pregnant women
clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
DCC in normal pregnant women
Delayed cord clamping group in normal pregnant women
clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
Interventions
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clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
Eligibility Criteria
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Inclusion Criteria
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
2. Insufficiency of vital organ function or complicated tumor;
3. Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Second Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Ying Hua
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Wenzhou Medical University
Locations
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department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SAHoWMU-CR2022-07-206
Identifier Type: -
Identifier Source: org_study_id
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