Delayed Cord Clamping at Term Cesarean

Not Applicable

Completed

• Conditions: Maternal Blood Loss; Delayed Cord Clamping; Cesarean Delivery; Neonatal Health
• Interventions: Procedure: Umbilical cord clamping

• Registration Number: NCT03150641
• Lead Sponsor: Columbia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Study Start: 2017-09-18
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

Inclusion Criteria

• Singleton gestation
• Scheduled cesarean delivery at term (>=37 weeks)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate cord clamping	Umbilical cord clamping	Umbilical cord clamped within 15 seconds of delivery of baby
Delayed cord clamping	Umbilical cord clamping	Umbilical cord clamped 60 seconds after delivery of baby

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States