Delayed Cord Clamping and Use of Oxytocin

Phase 3

Terminated

• Conditions: Placental Transfusion
• Interventions: Drug: Timing of administration of post partum Oxytocin

• Registration Number: NCT02618499
• Lead Sponsor: Fundacion para la Salud Materno Infantil

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.

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-12-01
• Study Start: 2016-05
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin inmediately at birth	Timing of administration of post partum Oxytocin	Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother.
oxytocin at 3 minutes	Timing of administration of post partum Oxytocin	Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped

Primary Outcome Measures

Name	Time	Method
placental transfusion	between birth and 3 minutes of life	Difference in body weight between birth and 3 minutes of life

Secondary Outcome Measures

Name	Time	Method
bilirubin	at 36/48 hours	Bilirubin level
Hematocrit	at 36/48 hours	Hematocrit levels
Maternal blood loss	after birth for 30 minutes	measure of the blood loss

Trial Locations

Locations (1)

Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced; 🇦🇷 San Miguel de Tucuman, Tucuman, Argentina