Delayed Cord Clamping and Use of Oxytocin

Fundacion para la Salud Materno Infantil

Status and phase: Terminated; Phase 3

Conditions: Placental Transfusion

Treatments: Drug: Timing of administration of post partum Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02618499

Funda05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

oxytocin inmediately at birth

Active Comparator group

Description:

Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother.

Treatment:

Drug: Timing of administration of post partum Oxytocin

oxytocin at 3 minutes

Experimental group

Description:

Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped

Treatment:

Drug: Timing of administration of post partum Oxytocin