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Delayed Cord Clamping and Use of Oxytocin

Is Placental Transfusion Influenced by the Early Administration of Oxytocin?

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02618499
Enrollment
180
Registered
2015-12-01
Start date
2016-05-31
Completion date
2016-11-30
Last updated
2016-11-23

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

Conditions

Placental Transfusion

Keywords

birth, oxytocin, placental transfusion, umbilical cord clamping

Brief summary

The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.

Detailed description

Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion. Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped. The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion. In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.

Interventions

DRUGTiming of administration of post partum Oxytocin

10 IU of oxytocin given IV at different times after birth

Sponsors

Fundacion para la Salud Materno Infantil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Healthy single Term pregnancies. * Vaginal delivery. * Informed consent obtained. * Presence of an investigator

Exclusion criteria

* Placenta previa. * Previous history of Postpartum hemorrhage * Intrauterine growth restriction . * Major congenital malformations. * Eclampsia * Extraction of blood sample for bank of umbilical cord stem cells. Elimination criteria: * Need for immediate assistance of the newborn * Birth weight less than 2500 g * Nuchal cord wrapped too tight * Surgically finished delivery * Short umbilical cord which might prevent placing the infant on the scale * Technical difficulties to obtain the weight

Design outcomes

Primary

MeasureTime frameDescription
placental transfusionbetween birth and 3 minutes of lifeDifference in body weight between birth and 3 minutes of life

Secondary

MeasureTime frameDescription
bilirubinat 36/48 hoursBilirubin level
Hematocritat 36/48 hoursHematocrit levels
Maternal blood lossafter birth for 30 minutesmeasure of the blood loss

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026