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Clinical Trials/NCT03150641
NCT03150641
Completed
Not Applicable

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

Columbia University1 site in 1 country113 target enrollmentStarted: September 18, 2017Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
113
Locations
1
Primary Endpoint
Maternal change in hemoglobin on post-operative day #1

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Maternal change in hemoglobin on post-operative day #1

Time Frame: 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 Outcomes

  • Maternal blood transfusion(From day of surgery to postpartum discharge (average 3-4 days))
  • Postpartum hemorrhage(From day of surgery to postpartum discharge (average 3-4 days))
  • Estimated blood loss(Day of surgery)
  • Need for Need for additional uterotonics(Day of surgery)
  • Venous cord blood Hgb/Hct(Day of delivery)
  • Neonatal Hgb/Hct(Day 0-2 of life)
  • APGAR scores(Day of delivery)
  • Need for phototherapy for jaundice(From birth to hospital discharge (average 3-4 days))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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