Clinical trial NCT03150641: Delayed Cord Clamping at Term Cesarean
Official title: Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Blood Loss
Cesarean Delivery
Delayed Cord Clamping
Neonatal Health
Keywords: Maternal blood loss
Cesarean delivery
Delayed cord clamping
Neonatal health
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maternal change in hemoglobin on post-operative day #1
timeFrame: Baseline to postoperative day #1 (range 1-4 days)
Secondary outcomes:
measure: Postpartum hemorrhage
timeFrame: From day of surgery to postpartum discharge (average 3-4 days)
measure: Estimated blood loss
timeFrame: Day of surgery
measure: Need for Need for additional uterotonics
timeFrame: Day of surgery
measure: Maternal blood transfusion
timeFrame: From day of surgery to postpartum discharge (average 3-4 days)
measure: Venous cord blood Hgb/Hct
timeFrame: Day of delivery
measure: Neonatal Hgb/Hct
timeFrame: Day 0-2 of life
measure: APGAR scores
timeFrame: Day of delivery
measure: Need for phototherapy for jaundice
timeFrame: From birth to hospital discharge (average 3-4 days)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Cynthia Gyamfi-Bannerman, MD
role: STUDY_CHAIR
References:
citation: Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995.