Timing of Umbilical Cord Clamping in Term Cesarean Deliveries
Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries
1 other identifier
interventional
204
1 country
1
Brief Summary
The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
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
March 17, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedStudy Start
First participant enrolled
March 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2021
CompletedAugust 3, 2021
July 1, 2021
4 months
March 17, 2021
July 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postpartum maternal hemorrhage
Preoperative and postoperative hemoglobin values will be recorded.
On postoperative day 0 and day 2
Secondary Outcomes (9)
Postpartum maternal anemia
İn postpartum 48 hours
Neonatal outcomes
Postpartum day 0
Postpartum complaints
İn postpartum 48 hours
Neonatal anemia
On postpartum day 2
Neonatal jaundice
On postpartum day 2
- +4 more secondary outcomes
Study Arms (3)
Delayed Clamping
ACTIVE COMPARATORIn this group, the umbilical cord will be clamped 60 seconds after the baby is born.
Early Clamping
ACTIVE COMPARATORIn this group, the umbilical cord will be clamped 15 seconds after the baby is born.
Milking Clamping
ACTIVE COMPARATORIn this group in which the umbilical cord will be milked, the cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
Interventions
The umbilical cord will be clamped 60 seconds after the baby is born.
The umbilical cord will be clamped 15 seconds after the baby is born.
The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
Eligibility Criteria
You may qualify if:
- \> 37 weeks uncomplicated singleton pregnancy
- Elective cesarean delivery
- Cesarean section under regional anesthesia
You may not qualify if:
- \< 37 weeks pregnancy
- Surgery performed under general anesthesia
- Emergent cesarean
- Multiple pregnancy
- Medically unstable mother or fetus
- Uncontrolled maternal diabetes
- Major congenital malformation of chromosomal abnormality of the fetus
- Intrauterine growth retardation
- Prenatal asphyxia suspicion
- True knot in the umbilical cord
- İn case of meconium aspiration syndrome suspicion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acibadem Maslak Hospital
Istanbul, Sariyer, 34457, Turkey (Türkiye)
Related Publications (6)
Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
PMID: 28002310BACKGROUNDMercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.
PMID: 22843002BACKGROUNDMcDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
PMID: 23843134BACKGROUNDSongthamwat M, Witsawapaisan P, Tanthawat S, Songthamwat S. Effect of Delayed Cord Clamping at 30 Seconds and 1 Minute on Neonatal Hematocrit in Term Cesarean Delivery: A Randomized Trial. Int J Womens Health. 2020 Jun 23;12:481-486. doi: 10.2147/IJWH.S248709. eCollection 2020.
PMID: 32607000BACKGROUNDPurisch 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: 31742629BACKGROUNDQian Y, Ying X, Wang P, Lu Z, Hua Y. Early versus delayed umbilical cord clamping on maternal and neonatal outcomes. Arch Gynecol Obstet. 2019 Sep;300(3):531-543. doi: 10.1007/s00404-019-05215-8. Epub 2019 Jun 15.
PMID: 31203386BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mete Gungor, MD, Prof.
Acıbadem Mehmet Ali Aydınlar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 17, 2021
First Posted
March 23, 2021
Study Start
March 25, 2021
Primary Completion
July 25, 2021
Study Completion
July 29, 2021
Last Updated
August 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share
Study protocol, statistical analysis might be shared when the study is completed upon request.