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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02187510
Enrollment
40
Registered
2014-07-11
Start date
2014-07-31
Completion date
2016-03-31
Last updated
2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Clamping, Milking, Premature Infant, Umbilical Cord

Keywords

Hemodynamics, Premature Infant, Umbilical cord, Milking, Delayed clamping

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.

Interventions

PROCEDUREUmbilical 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.

PROCEDUREDelayed 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.

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Haemoglobin1 hour and 24 hours at borng/dl

Secondary

MeasureTime frameDescription
Arterial pressure2, 6, 12, 24, 36 and 48 hours of lifeMean of systolic and dyastolic arterial pressure in mm Hg
Orine volume24 and 48 hours of lifeTotal volume of orine at 24 and 48 hours of life. Total ml.
Use of vasopresors drugs24 hours of lifeTo use or not to use the vasopresors drugs during the first 24 hours of life
Number of concentrate hematies transfusionparticipants 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.
Apgar Score1 and 5 minutesBasic score to mesure the newborn status. From 0 to 10.
Bronchopulmonary dysplasiaparticipants 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)
Total intensive care unit stayParticipants 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.
Hematocrit1 hour and 24 hours at bornIn percentage
Intraventricular hemorrhageparticipants 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026