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

NCT03741803 | Completed

• 1 other identifier: HSC-MS-17-0803
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• Neonatal bilirubin level

  24 hours after birth

Secondary Outcomes (6)

• Number of neonates with hyperbilirubinemia

  24 hours 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 mothers with postpartum hemorrhage

  From birth to up to 1 week after birth

Study Arms (2)

Delayed cord clamping

ACTIVE COMPARATOR

Procedure: Delayed cord clamping

Early cord clamping

ACTIVE COMPARATOR

Procedure: Early cord clamping

Interventions

Delayed cord clamping PROCEDURE

The umbilical cord will be clamped after 60 seconds after birth

Delayed cord clamping

Early cord clamping PROCEDURE

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

Early cord clamping

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pamela D Berens, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: November 9, 2018
• Primary Completion: May 27, 2019
• Study Completion: May 27, 2019
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)