Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
1 other identifier
interventional
122
1 country
1
Brief Summary
Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased
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 Apr 2020
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
April 16, 2020
CompletedStudy Start
First participant enrolled
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedAugust 24, 2021
August 1, 2021
11 months
April 16, 2020
August 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level
The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level.
day 1 after delivery
Secondary Outcomes (4)
postpartum hemorrhage
at the time of delivery
uterotonic administration
at the time of delivery
need for blood transfusion
at the time of delivery
jaundice
day 10 of life
Study Arms (2)
Immediate cord clamping
ACTIVE COMPARATORImmediate cord clamping was defined as clampingwithin 15 seconds of birth
delayed cord clamping
EXPERIMENTALwhen the cord stopped pulsing, or five minutes
Interventions
Eligibility Criteria
You may qualify if:
- singleton pregnancy
- at term
- cephalic presentation
- spontaneous labor
- spontaneous vaginal delivery
You may not qualify if:
- multiple gestation
- preterm gestation
- induced labor
- operative delivery
- hypertension or preeclampsia
- fetal anomaly
- abnormal placentation
- planned cord blood banking
- maternal bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Casa di Cura Accreditata Fabia Mater, Rome, Italy
Rome, Roma, 80129, Italy
Related Publications (1)
De Angelis C, Saccone G, Sorichetti E, Alagna M, Zizolfi B, Gragnano E, Legnante A, Sardo ADS. Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial. Int J Gynaecol Obstet. 2022 Dec;159(3):898-902. doi: 10.1002/ijgo.14223. Epub 2022 May 2.
PMID: 35428979DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator, medical doctor
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 20, 2020
Study Start
April 16, 2020
Primary Completion
February 25, 2021
Study Completion
May 1, 2021
Last Updated
August 24, 2021
Record last verified: 2021-08