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

Study Overview
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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.

Official Title
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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

Conditions
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Hyperbilirubinemia, Neonatal, Jaundice, Neonatal

Intervention / Treatment
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* Procedure: Delayed cord clamping
* Procedure: Early cord clamping


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed cord clamping<br> | Procedure: Delayed cord clamping<br>* The umbilical cord will be clamped after 60 seconds after birth<br>|
| Active Comparator: Early cord clamping<br> | Procedure: Early cord clamping<br>* The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal bilirubin level |  | 24 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates with hyperbilirubinemia | Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood. | 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 | 
| Number of neonates re-hospitalized for jaundice |  | From birth to up to 1 week after birth |