Delayed Cord Clamping and Use of Oxytocin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Placental Transfusion Influenced by the Early Administration of Oxytocin?

Conditions
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Placental Transfusion

Intervention / Treatment
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* Drug: Timing of administration of post partum Oxytocin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxytocin inmediately at birth<br>Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother. | Drug: Timing of administration of post partum Oxytocin<br>* 10 IU of oxytocin given IV at different times after birth<br>* Other names: syntosinon;|
| Experimental: oxytocin at 3 minutes<br>Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped | Drug: Timing of administration of post partum Oxytocin<br>* 10 IU of oxytocin given IV at different times after birth<br>* Other names: syntosinon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| placental transfusion | Difference in body weight between birth and 3 minutes of life | between birth and 3 minutes of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bilirubin | Bilirubin level | at 36/48 hours | 
| Hematocrit | Hematocrit levels | at 36/48 hours | 
| Maternal blood loss | measure of the blood loss | after birth for 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth, oxytocin, placental transfusion, umbilical cord clamping