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Delayed Cord Clamping at Term Cesarean

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT03150641
Collaborator
(none)
113
Enrollment
1
Location
2
Arms
6.4
Actual Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Umbilical cord clamping
 N/A

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
Actual Enrollment :
113 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
Actual Study Start Date :
Sep 18, 2017
Actual Primary Completion Date :
Mar 30, 2018
Actual Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Immediate cord clamping

Umbilical cord clamped within 15 seconds of delivery of baby

Procedure: Umbilical cord clamping
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
Experimental: Delayed cord clamping

Umbilical cord clamped 60 seconds after delivery of baby

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Postpartum hemorrhage [From day of surgery to postpartum discharge (average 3-4 days)]

    Incidence of postpartum hemorrhage, defined as EBL >1000cc

  2. Estimated blood loss [Day of surgery]

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

  3. Need for Need for additional uterotonics [Day of surgery]

    Administration of uterotonics (beyond standard pitocin) during cesarean

  4. Maternal blood transfusion [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 [Day of delivery]

    Obtained from cord blood sample

  6. Neonatal Hgb/Hct [Day 0-2 of life]

    Obtained from neonatal heel stick

  7. APGAR scores [Day of delivery]

    Assigned at delivery

  8. Need for phototherapy for jaundice [From birth to hospital discharge (average 3-4 days)]

    Any use of phototherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Irving Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University

Investigators

  • Study Chair: Cynthia Gyamfi-Bannerman, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT03150641
Other Study ID Numbers:
  • AAAR2937
First Posted:
May 12, 2017
Last Update Posted:
May 22, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Columbia University
Maternal blood loss
Cesarean delivery
Delayed cord clamping
Neonatal health
Additional relevant MeSH terms:
Hemorrhage

Study Results

No Results Posted as of May 22, 2019