Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.

Official Title
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Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial

Conditions
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Premature Infant, Umbilical Cord, Milking, Delayed Clamping

Intervention / Treatment
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* Procedure: Umbilical cord milking
* Procedure: Delayed cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants less than 34 weeks' gestation born by cesarean section Exclusion Criteria: Inability to obtain informed consent from the mother state Monochorionic-monoamniotic twin gestation Placenta abruption Uterine rupture Transplacental cesarean Hydrops fetalis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord milking<br>Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord. | Procedure: Umbilical cord milking<br>* Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.<br>|
| Active Comparator: Delayed cord clamping<br>Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord. | Procedure: Delayed cord clamping<br>* Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin | g/dl | 1 hour and 24 hours at born | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar Score | Basic score to mesure the newborn status. From 0 to 10. | 1 and 5 minutes | 
| Arterial pressure | Mean of systolic and dyastolic arterial pressure in mm Hg | 2, 6, 12, 24, 36 and 48 hours of life | 
| Orine volume | Total volume of orine at 24 and 48 hours of life. Total ml. | 24 and 48 hours of life | 
| Use of vasopresors drugs | To use or not to use the vasopresors drugs during the first 24 hours of life | 24 hours of life | 
| Number of concentrate hematies transfusion | Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months. | participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months) | 
| Intraventricular hemorrhage | Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile | participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months) | 
| Bronchopulmonary dysplasia | Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna) | participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months) | 
| Total intensive care unit stay | Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months. | Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months) | 
| Hematocrit | In percentage | 1 hour and 24 hours at born | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Infant, Umbilical cord, Hemodynamics, Milking, Delayed clamping