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

Not Applicable

Suspended

• Conditions: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
• Interventions: Procedure: Delayed cord clamping; Procedure: Early cord clamping

• Registration Number: NCT03741803
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed cord clamping	Delayed cord clamping	-
Early cord clamping	Early cord clamping	-

Primary Outcome Measures

Name	Time	Method
Neonatal bilirubin level	24 hours after birth

Secondary Outcome Measures

Name	Time	Method
Number of mothers with postpartum hemorrhage	From birth to up to 1 week after birth
Number of neonates with a need for phototherapy	From birth to up to 1 week after birth
Number of neonates with a need for exchange transfusion	From birth to up to 1 week after birth
Number of neonates admitted to the neonatal intensive care unit (NICU)	From birth to up to 1 week after birth
Number of neonates with hyperbilirubinemia	24 hours after birth	Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.
Number of neonates re-hospitalized for jaundice	From birth to up to 1 week after birth

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States