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

April 27, 2016 updated by: Mònica Domingo Puiggròs, Corporacion Parc Tauli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apgar Score
Time Frame: 1 and 5 minutes
Basic score to mesure the newborn status. From 0 to 10.
1 and 5 minutes
Arterial pressure
Time Frame: 2, 6, 12, 24, 36 and 48 hours of life
Mean of systolic and dyastolic arterial pressure in mm Hg
2, 6, 12, 24, 36 and 48 hours of life
Orine volume
Time Frame: 24 and 48 hours of life
Total volume of orine at 24 and 48 hours of life. Total ml.
24 and 48 hours of life
Use of vasopresors drugs
Time Frame: 24 hours of life
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
Time Frame: 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.
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Intraventricular hemorrhage
Time Frame: 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
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Bronchopulmonary dysplasia
Time Frame: 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)
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Total intensive care unit stay
Time Frame: 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.
Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Hematocrit
Time Frame: 1 hour and 24 hours at born
In percentage
1 hour and 24 hours at born

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Study Director: Monica Domingo-Puiggros, MD, Corporacio Sanitaria Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPTNeonat2014_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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