Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE May 12, 2017
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE September 18, 2017
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • Postpartum hemorrhage [ Time Frame: From day of surgery to postpartum discharge (average 3-4 days) ]
    Incidence of postpartum hemorrhage, defined as EBL >1000cc
  • Estimated blood loss [ Time Frame: Day of surgery ]
    Estimated blood loss at cesarean delivery, based on estimation provider team
  • Need for Need for additional uterotonics [ Time Frame: Day of surgery ]
    Administration of uterotonics (beyond standard pitocin) during cesarean
  • Maternal blood transfusion [ Time Frame: From day of surgery to postpartum discharge (average 3-4 days) ]
    Transfusion of blood products during or after delivery
  • Venous cord blood Hgb/Hct [ Time Frame: Day of delivery ]
    Obtained from cord blood sample
  • Neonatal Hgb/Hct [ Time Frame: Day 0-2 of life ]
    Obtained from neonatal heel stick
  • APGAR scores [ Time Frame: Day of delivery ]
    Assigned at delivery
  • Need for phototherapy for jaundice [ Time Frame: From birth to hospital discharge (average 3-4 days) ]
    Any use of phototherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delayed Cord Clamping at Term Cesarean
Official Title  ICMJE Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Maternal Blood Loss
  • Cesarean Delivery
  • Delayed Cord Clamping
  • Neonatal Health
Intervention  ICMJE Procedure: Umbilical cord clamping
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
Study Arms  ICMJE
  • Immediate cord clamping
    Umbilical cord clamped within 15 seconds of delivery of baby
    Intervention: Procedure: Umbilical cord clamping
  • Experimental: Delayed cord clamping
    Umbilical cord clamped 60 seconds after delivery of baby
    Intervention: Procedure: Umbilical cord clamping
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2018)
113
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2017)
80
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03150641
Other Study ID Numbers  ICMJE AAAR2937
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Cynthia Gyamfi-Bannerman, MD Columbia University
PRS Account Columbia University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP