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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Suspended

Conditions

Hyperbilirubinemia, Neonatal
Jaundice, Neonatal

Treatments

Procedure: Early cord clamping
Procedure: Delayed cord clamping

Study type

Interventional

Funder types

Other

Identifiers

NCT03741803
HSC-MS-17-0803

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Delayed cord clamping
Active Comparator group
Treatment:
Procedure: Delayed cord clamping
Early cord clamping
Active Comparator group
Treatment:
Procedure: Early cord clamping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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