Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice

NCT ID: NCT03741803

Last Updated: 2024-05-08

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2025-06-30

Brief Summary

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The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.

Detailed Description

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Conditions

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Hyperbilirubinemia, Neonatal Jaundice, Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Delayed cord clamping

Group Type ACTIVE_COMPARATOR

Delayed cord clamping

Intervention Type PROCEDURE

The umbilical cord will be clamped after 60 seconds after birth

Early cord clamping

Group Type ACTIVE_COMPARATOR

Early cord clamping

Intervention Type PROCEDURE

The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.

Interventions

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Delayed cord clamping

The umbilical cord will be clamped after 60 seconds after birth

Intervention Type PROCEDURE

Early cord clamping

The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* mothers delivering at 35 weeks or greater
* mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia
* multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)

Exclusion Criteria

\- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Pamela Berens

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela D Berens, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-17-0803

Identifier Type: -

Identifier Source: org_study_id

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