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Delayed Cord Clamping at Term Cesarean

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03150641
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Maternal Blood Loss Cesarean Delivery Delayed Cord Clamping Neonatal Health Procedure: Umbilical cord clamping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 18, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 31, 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150641


Locations
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United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Study Chair: Cynthia Gyamfi-Bannerman, MD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT03150641    
Other Study ID Numbers: AAAR2937
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hemorrhage
Pathologic Processes