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Supine vs Prone Position During Delayed Cord Clamping

Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03697967
Acronym
DCC
Enrollment
210
Registered
2018-10-05
Start date
2019-03-01
Completion date
2021-11-01
Last updated
2022-04-14

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

Conditions

Newborn; Anemia, Umbilical Cord Problem

Keywords

Delayed cord clamping

Brief summary

This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position.

Detailed description

At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic screening sample. There is no added heelstick to routine care, as current standard in our institution requires the bilirubin to be drawn at 30 hours of life. During universal screening for congenital cardiac defects (30 hours of life), a value of cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy, INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead and the newborn is in supine position.

Interventions

PROCEDUREsupine or prone position

Before delivery, a sealed enveloppe is opened by the physician or nurse present at delivery. Immediately at birth the team in charge of delivery place the newborn in skin to skin contact on the mother's chest where he is dried. Umbilical cord clamping is delayed in both intervention arms to 1 minute after birth. The newborn is placed in the prone or in the supine position depending on allocation. The nurse in charge of the newborn uses a stopwatch to check the time at which clamping was accomplished. All subsequent nursery care are conducted according to hospital protocol.

Sponsors

Maisonneuve-Rosemont Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Randomised two arms study

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 2 Minutes
Healthy volunteers
Yes

Inclusion criteria

Newborn ≥ 36 weeks gestational age and Born vaginally and Well appearing

Exclusion criteria

Out born infant, Infant born by caesarian section, Preterm born less than 36 weeks GA, Infant with intra uterine growth restriction (IUGR: less than 10th percentile) Asphyxiated infant Infant needing immediate resuscitation, Newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease Newborn with mother with preeclampsia or gestational hypertension or diabetes on insuline or hemolytic disease or on chemotherapy or on cortisone.

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin and hematocrit24-48 hoursHemoglobin value

Secondary

MeasureTime frameDescription
Cerebral saturation by near infrared spectroscopy (NIRS)24-48 H of lifeCerebral saturation by near infrared spectroscopy
Bilirubin24-48 hoursBilirubin value

Countries

Canada

Outcome results

None listed

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