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Delayed Cord Clamping at Term Cesarean

Primary Purpose

Maternal Blood Loss, Cesarean Delivery, Delayed Cord Clamping

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Umbilical cord clamping
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Blood Loss focused on measuring Maternal blood loss, Cesarean delivery, Delayed cord clamping, Neonatal health

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Immediate cord clamping

Delayed cord clamping

Arm Description

Umbilical cord clamped within 15 seconds of delivery of baby

Umbilical cord clamped 60 seconds after delivery of baby

Outcomes

Primary Outcome Measures

Maternal change in hemoglobin on post-operative day #1
Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture

Secondary Outcome Measures

Postpartum hemorrhage
Incidence of postpartum hemorrhage, defined as EBL >1000cc
Estimated blood loss
Estimated blood loss at cesarean delivery, based on estimation provider team
Need for Need for additional uterotonics
Administration of uterotonics (beyond standard pitocin) during cesarean
Maternal blood transfusion
Transfusion of blood products during or after delivery
Venous cord blood Hgb/Hct
Obtained from cord blood sample
Neonatal Hgb/Hct
Obtained from neonatal heel stick
APGAR scores
Assigned at delivery
Need for phototherapy for jaundice
Any use of phototherapy

Full Information

First Posted
May 9, 2017
Last Updated
May 20, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03150641
Brief Title
Delayed Cord Clamping at Term Cesarean
Official Title
Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Blood Loss, Cesarean Delivery, Delayed Cord Clamping, Neonatal Health
Keywords
Maternal blood loss, Cesarean delivery, Delayed cord clamping, Neonatal health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate cord clamping
Arm Type
Other
Arm Description
Umbilical cord clamped within 15 seconds of delivery of baby
Arm Title
Delayed cord clamping
Arm Type
Experimental
Arm Description
Umbilical cord clamped 60 seconds after delivery of baby
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord clamping
Intervention Description
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
Primary Outcome Measure Information:
Title
Maternal change in hemoglobin on post-operative day #1
Description
Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture
Time Frame
Baseline to postoperative day #1 (range 1-4 days)
Secondary Outcome Measure Information:
Title
Postpartum hemorrhage
Description
Incidence of postpartum hemorrhage, defined as EBL >1000cc
Time Frame
From day of surgery to postpartum discharge (average 3-4 days)
Title
Estimated blood loss
Description
Estimated blood loss at cesarean delivery, based on estimation provider team
Time Frame
Day of surgery
Title
Need for Need for additional uterotonics
Description
Administration of uterotonics (beyond standard pitocin) during cesarean
Time Frame
Day of surgery
Title
Maternal blood transfusion
Description
Transfusion of blood products during or after delivery
Time Frame
From day of surgery to postpartum discharge (average 3-4 days)
Title
Venous cord blood Hgb/Hct
Description
Obtained from cord blood sample
Time Frame
Day of delivery
Title
Neonatal Hgb/Hct
Description
Obtained from neonatal heel stick
Time Frame
Day 0-2 of life
Title
APGAR scores
Description
Assigned at delivery
Time Frame
Day of delivery
Title
Need for phototherapy for jaundice
Description
Any use of phototherapy
Time Frame
From birth to hospital discharge (average 3-4 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Gyamfi-Bannerman, MD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31742629
Citation
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.
Results Reference
derived

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Delayed Cord Clamping at Term Cesarean

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