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Completed

NCT Number: NCT02187510

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

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.

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Key information

Conditions

Premature Infant Delayed Clamping Female Urogenital Diseases and Pregnancy Complications Milking Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Umbilical Cord Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

Procedure

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

Procedure

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 outcomes

  1. Haemoglobin

    Time frame: 1 hour and 24 hours at born

    g/dl

Secondary outcomes

  1. Apgar Score

    Time frame: 1 and 5 minutes

    Basic score to mesure the newborn status. From 0 to 10.

  2. Arterial pressure

    Time frame: 2, 6, 12, 24, 36 and 48 hours of life

    Mean of systolic and dyastolic arterial pressure in mm Hg

  3. Orine volume

    Time frame: 24 and 48 hours of life

    Total volume of orine at 24 and 48 hours of life. Total ml.

  4. 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

  5. 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.

  6. 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

  7. 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)

  8. 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.

  9. Hematocrit

    Time frame: 1 hour and 24 hours at born

    In percentage

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2014
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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