Delayed Cord Clamping and Use of Oxytocin

November 22, 2016 updated by: Fundacion para la Salud Materno Infantil

Is Placental Transfusion Influenced by the Early Administration of Oxytocin?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina
        • Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oxytocin inmediately at birth
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
10 IU of oxytocin given IV at different times after birth
Other Names:
  • syntosinon
Experimental: oxytocin at 3 minutes
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
10 IU of oxytocin given IV at different times after birth
Other Names:
  • syntosinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
placental transfusion
Time Frame: between birth and 3 minutes of life
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
Time Frame: at 36/48 hours
Bilirubin level
at 36/48 hours
Hematocrit
Time Frame: at 36/48 hours
Hematocrit levels
at 36/48 hours
Maternal blood loss
Time Frame: after birth for 30 minutes
measure of the blood loss
after birth for 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Salud Materno Infantil

Investigators

  • Study Director: Nestor Vain, MD, Fundasamin
  • Principal Investigator: Daniela S Satragno, MD, Fundasamin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Funda05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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