Delayed Cord Clamping at Term Cesarean
Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term
1 other identifier
interventional
113
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedMay 22, 2019
May 1, 2019
6 months
May 9, 2017
May 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to postoperative day #1 (range 1-4 days)
Secondary Outcomes (8)
Postpartum hemorrhage
From day of surgery to postpartum discharge (average 3-4 days)
Estimated blood loss
Day of surgery
Need for Need for additional uterotonics
Day of surgery
Maternal blood transfusion
From day of surgery to postpartum discharge (average 3-4 days)
Venous cord blood Hgb/Hct
Day of delivery
- +3 more secondary outcomes
Study Arms (2)
Immediate cord clamping
OTHERUmbilical cord clamped within 15 seconds of delivery of baby
Delayed cord clamping
EXPERIMENTALUmbilical cord clamped 60 seconds after delivery of baby
Interventions
The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
Eligibility Criteria
You may qualify if:
- Singleton gestation
- Scheduled cesarean delivery at term (\>=37 weeks)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 31742629DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cynthia Gyamfi-Bannerman, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 12, 2017
Study Start
September 18, 2017
Primary Completion
March 30, 2018
Study Completion
March 31, 2018
Last Updated
May 22, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share