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Completed

NCT Number: NCT03150641

Delayed Cord Clamping at Term Cesarean

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.

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Key information

Conditions

Maternal Blood Loss Cesarean Delivery Delayed Cord Clamping Neonatal Health

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Umbilical cord clamping

Procedure

The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm

Primary outcomes

  1. 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

  1. Postpartum hemorrhage

    Time frame: From day of surgery to postpartum discharge (average 3-4 days)

    Incidence of postpartum hemorrhage, defined as EBL >1000cc

  2. Estimated blood loss

    Time frame: Day of surgery

    Estimated blood loss at cesarean delivery, based on estimation provider team

  3. Need for Need for additional uterotonics

    Time frame: Day of surgery

    Administration of uterotonics (beyond standard pitocin) during cesarean

  4. Maternal blood transfusion

    Time frame: From day of surgery to postpartum discharge (average 3-4 days)

    Transfusion of blood products during or after delivery

  5. Venous cord blood Hgb/Hct

    Time frame: Day of delivery

    Obtained from cord blood sample

  6. Neonatal Hgb/Hct

    Time frame: Day 0-2 of life

    Obtained from neonatal heel stick

  7. APGAR scores

    Time frame: Day of delivery

    Assigned at delivery

  8. Need for phototherapy for jaundice

    Time frame: From birth to hospital discharge (average 3-4 days)

    Any use of phototherapy

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 12, 2017
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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