Delayed Cord Clamping at Term Cesarean

Study Overview
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Brief Summary
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The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.

Detailed Description
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After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.

Official Title
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Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term

Conditions
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Maternal Blood Loss, Cesarean Delivery, Delayed Cord Clamping, Neonatal Health

Intervention / Treatment
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* Procedure: Umbilical cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton gestation Scheduled cesarean delivery at term (>=37 weeks) Exclusion Criteria: Placenta previa Placenta abruption Intrauterine growth restriction with abnormal Dopplers Fetal anomalies Known fetal anemia Planned cord blood banking Preeclampsia Significant maternal anemia (Hgb <=7)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: Immediate cord clamping<br>Umbilical cord clamped within 15 seconds of delivery of baby | Procedure: Umbilical cord clamping<br>* The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm<br>|
| Experimental: Delayed cord clamping<br>Umbilical cord clamped 60 seconds after delivery of baby | Procedure: Umbilical cord clamping<br>* The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal change in hemoglobin on post-operative day #1 | Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture | Baseline to postoperative day #1 (range 1-4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum hemorrhage | Incidence of postpartum hemorrhage, defined as EBL >1000cc | From day of surgery to postpartum discharge (average 3-4 days) | 
| Estimated blood loss | Estimated blood loss at cesarean delivery, based on estimation provider team | Day of surgery | 
| Need for Need for additional uterotonics | Administration of uterotonics (beyond standard pitocin) during cesarean | Day of surgery | 
| Maternal blood transfusion | Transfusion of blood products during or after delivery | From day of surgery to postpartum discharge (average 3-4 days) | 
| Venous cord blood Hgb/Hct | Obtained from cord blood sample | Day of delivery | 
| Neonatal Hgb/Hct | Obtained from neonatal heel stick | Day 0-2 of life | 
| APGAR scores | Assigned at delivery | Day of delivery | 
| Need for phototherapy for jaundice | Any use of phototherapy | From birth to hospital discharge (average 3-4 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal blood loss, Cesarean delivery, Delayed cord clamping, Neonatal health