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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03549884 |
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Date of registration:
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26/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Delayed Cord Clamping in Infants Born by Cesarean Section
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Scientific title:
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Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial |
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Date of first enrolment:
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April 17, 2018 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03549884 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Daniele Trevisanuto, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Padova, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Elective cesarean section
- Gestational age > or = 39 weeks
- No labor
- Single pregnancy
- Parental consent; a written informed consent will be obtained by a member of the
neonatal team involved in the study from a parent or guardian
Exclusion Criteria:
- Emergent or urgent cesarean sections
- Twin pregnancies
- Parental refusal to participate to the study
- Major congenital malformations (such as cardiopathies)
- Chromosomic abnormalities
- Fetal hydrops
- Severe maternal diseases (such as hypertension)
- Cord abnormalities (length < 20 cm, funicular prolapse, funicular knots)
- Intrauterine growth restriction (IUGR)
Age minimum:
N/A
Age maximum:
3 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Umbilical Cord Management
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Elective Cesarean Section
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Intervention(s)
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Procedure: Delayed cord clamping
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Procedure: Early cord clamping
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Primary Outcome(s)
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Hematocrit
[Time Frame: Day 2 of life]
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Secondary Outcome(s)
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Arterial blood pressure
[Time Frame: At day 1, 2, 3 of life]
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Temperature at Normal nursery admission
[Time Frame: At the time of normal nursery admission]
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Time to the first breath
[Time Frame: At birth]
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Maternal blood losses
[Time Frame: At delivery]
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Total transcutaneous bilirubin
[Time Frame: Day 3 of life]
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Weight
[Time Frame: Day 3 of life]
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Heart rate
[Time Frame: During the first 10 minutes of life]
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Preductal transcutaneous saturation (TcSaO2)
[Time Frame: During the first 10 minutes of life]
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Secondary ID(s)
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4443/AO/18
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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