- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351997
Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during natural 'two-step' delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values and placental transfusion. The most effective way to manage umbilical cord in in 'two-step' delivery remains to be established.
Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by 'two-step' delivery. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Abano Terme, Italy
- Policlinico Abano Terme
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Padua, Italy, 35128
- PADUA UNIVERSITY HOSPITAL
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Padua
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Abano Terme, Padua, Italy, 35031
- Policlinico Abano Terme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Vaginal delivery Gestational age >37 weeks Natural process of labor
Exclusion Criteria:
Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Early cord clamping
Cord clamping at 60 seconds after birth.
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Umbilical cord clamping after delivery.
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EXPERIMENTAL: Delayed cord clamping
Cord clamping at 180 seconds after birth,
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Umbilical cord clamping after delivery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Placental transfusion
Time Frame: Second day of life
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We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age.
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Second day of life
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial cord blood gas analysis.
Time Frame: Second day of life.
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Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
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Second day of life.
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Neonatal body weight decrease.
Time Frame: First and second day of life
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Neonatal body weight (Kg) and weight at discharge (Kg)
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First and second day of life
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Blood gases
Time Frame: At birth
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pH (units)
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At birth
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Lactate
Time Frame: At birth
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mmol/L
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At birth
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Glucose
Time Frame: At birth
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mg%
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At birth
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3158/AT/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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-
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-
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-
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