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

Not Applicable

Completed

• Conditions: Umbilical Cord; Premature Infant; Milking; Delayed Clamping
• Interventions: Procedure: Umbilical cord milking; Procedure: Delayed cord clamping

• Registration Number: NCT02187510
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-06
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical cord milking	Umbilical cord milking	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.
Delayed cord clamping	Delayed cord clamping	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.

Primary Outcome Measures

Name	Time	Method
Haemoglobin	1 hour and 24 hours at born	g/dl

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Corporacio Sanitaria Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain