Influence of Umbilical Cord Clamping Time in the Newborn

Study Overview
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Brief Summary
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This study compares two umbilical cord clamping times; the early one, up to a minute (ECC) and the late or delayed one, when the cord stop beating (DCC). The additional blood volume delivered to the newborn from the placenta - placental transference - by delaying umbilical cord ligation, increases the contribution of neonatal iron with increased iron stores in the infant, without increasing neonatal morbidity.

Detailed Description
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It is an intervention study without drugs administration with a longitudinal, prospective comparison and correlational design. Patients are recruited by simple random sampling to one of the two intervention groups: Group 1-ECC: Early clamping of the umbilical cord (before the first minute of life). Group 2-DCC: Delayed clamping of the umbilical cord (when it stops beating).

Official Title
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Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate

Conditions
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Anemia Neonatal, Polycythemia Secondary, Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Procedure: ECC
* Procedure: DCC
* Procedure: Blood Test 6hours
* Procedure: Blood Test 24hours
* Procedure: Blood Test 48hours
* Procedure: Blood Test 28days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery. Exclusion Criteria: monochorionic multiples incarcerated mothers placenta previa concern for abruptions Rh sensitization hydrops congenital anomalies the obstetrician declining to perform the intervention

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trials comparing early and late cord clamping
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: ECC<br>In the ECC group, the cord was clamped immediately after delivery, before the first minute of life. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping | Procedure: ECC<br>* Early clamping of the umbilical cord<br>Procedure: Blood Test 6hours<br>* Blood Test 6hours<br>Procedure: Blood Test 24hours<br>* Blood Test 24hours<br>Procedure: Blood Test 48hours<br>* Blood Test 48hours<br>Procedure: Blood Test 28days<br>* Blood Test 28days<br>|
| Experimental: Group 2: DCC<br>In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping | Procedure: DCC<br>* Delayed clamping of the umbilical cord<br>Procedure: Blood Test 6hours<br>* Blood Test 6hours<br>Procedure: Blood Test 24hours<br>* Blood Test 24hours<br>Procedure: Blood Test 48hours<br>* Blood Test 48hours<br>Procedure: Blood Test 28days<br>* Blood Test 28days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemoglobin | haemoglobin level | 6hours | 
| haemoglobin | haemoglobin level | 28 days | 
| haematocrit | haematocrit level | 6 hours | 
| haematocrit | haematocrit level | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum ferritin | serum ferritin level | 6hours | 
| serum ferritin | serum ferritin level | 28days | 
| bilirubin | bilirubin level | 6hours | 
| bilirubin | bilirubin level | 28days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical cord clamping, Anemia Neonatal, Iron metabolism disorders