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Completed

NCT Number: NCT03741803

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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Delayed Cord Clamping

Procedure

The umbilical cord will be clamped after 60 seconds after birth

Early Cord Clamping

Procedure

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

Primary outcomes

  1. Neonatal bilirubin level

    Time frame: 24 hours after birth

Secondary outcomes

  1. Number of neonates with hyperbilirubinemia

    Time frame: 24 hours after birth

    Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood.

  2. Number of neonates with a need for phototherapy

    Time frame: From birth to up to 1 week after birth

  3. Number of neonates with a need for exchange transfusion

    Time frame: From birth to up to 1 week after birth

  4. Number of neonates admitted to the neonatal intensive care unit (NICU)

    Time frame: From birth to up to 1 week after birth

  5. Number of mothers with postpartum hemorrhage

    Time frame: From birth to up to 1 week after birth

  6. Number of neonates re-hospitalized for jaundice

    Time frame: From birth to up to 1 week after birth

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Randomized Controlled Trial to Evaluate the Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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