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

Primary Purpose

Intrahepatic Cholestasis of Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
clamp time of umbilical
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrahepatic Cholestasis of Pregnancy focused on measuring Intrahepatic cholestasis during pregnancy, neonatal bilirubin, bilirubin, ICP, neonatal jaundice

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Other

Experimental

Arm Label

ICC in pregnant women with ICP

DCC in pregnant women with ICP

ICC in normal pregnant women

DCC in normal pregnant women

Arm Description

Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy

Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy

Immediate cord clamping group in normal pregnant women

Delayed cord clamping group in normal pregnant women

Outcomes

Primary Outcome Measures

the neonatal bilirubin values
the neonatal bilirubin values

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
February 19, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05637151
Brief Title
Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Official Title
Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholestasis of Pregnancy
Keywords
Intrahepatic cholestasis during pregnancy, neonatal bilirubin, bilirubin, ICP, neonatal jaundice

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICC in pregnant women with ICP
Arm Type
Other
Arm Description
Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
Arm Title
DCC in pregnant women with ICP
Arm Type
Experimental
Arm Description
Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
Arm Title
ICC in normal pregnant women
Arm Type
Other
Arm Description
Immediate cord clamping group in normal pregnant women
Arm Title
DCC in normal pregnant women
Arm Type
Experimental
Arm Description
Delayed cord clamping group in normal pregnant women
Intervention Type
Other
Intervention Name(s)
clamp time of umbilical
Intervention Description
The umbilical cord was clamped immediately or late for more than 30s
Primary Outcome Measure Information:
Title
the neonatal bilirubin values
Description
the neonatal bilirubin values
Time Frame
2-4 days after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Hua
Phone
+8613676403165
Ext
+8613676403165
Email
wzfeyhy1015@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Hua
Organizational Affiliation
Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ying hua
Phone
+8613676403165
Email
wzfeyhy1015@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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