Placental Transfusion and Cord Clamping

October 17, 2012 updated by: Fundacion para la Salud Materno Infantil

Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?

To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No inferiority, Randomized controlled trial not blind, Multicenter. Informed consent will be obtained during pregnancy or admittance and previous to birth.

Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus

Term newborns by vaginal delivery and without complications will be included. Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.

In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.

Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.

In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obtained after clamping.

Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

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
    • Buenos Aires
      • San Isidro, Buenos Aires, Argentina
        • Hospital Materno Infantil de San Isidro Dr. C. Gianantonio
    • Caba
      • Buenos Aires, Caba, Argentina
        • Sanatorio De la Trinidad Palermo
    • Tucumán
      • San Miguel de Tucumán, Tucumán, Argentina
        • Instituto de Meternidad y ginecología Nuestra señora de las Mercedes

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

No older than 2 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Term newborns
  • vigorous born by vaginal delivery
  • informed consent Signed.

Exclusion Criteria:

  • History of Placenta previa,
  • postpartum hemorrhage background,
  • Multiple gestation.
  • Background of IUGR prenatally diagnosed.
  • Major congenital malformations diagnosed previous to delivery.
  • Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
  • 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,
  • Major congenital malformations not diagnosed during prenatal period,
  • Delivery surgically finished Short umbilical cord which might prevent placing the infant in the assigned place .

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Position at introitus level
The newborn will be held by the neonatologist at the level of the introitus, the cord will be clamped at 2 minutes after birth. New weigh will be obtained after that.
Procedure: Position at introitus level
After birth: Weigh at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec then another Weigh will be obtained after clamping
Experimental: Position at Maternal Abdomen
The newborn will be placed on the abdomen and of the mother immediately after the first weigh measurement. The cord will be clamped at 2 minutes after birth .
Procedure: position at Maternal Abdomen
After birth: Weight at 10 + 2 sec then the baby will be placed at maternal abdomen and Cord clamping will be performed at 120 sec and new Weigh will be obtained after clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen.
Time Frame: inmediately after birth until 2 minutes after birth

Every elegible and randomiced newborn will be Immediately after birth placed on a scale at the level of the introitus, and the infant's weight will be recorded at 10± 2 sec.

Group 1: The infant will be held by the neonatologist at introitus level. The cord will be clamped at 120 seconds after birth.

Group 2: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement. The cord will be clamped at 120 seconds after birth.

Both groups will be weigth after the cord clamping.
inmediately after birth until 2 minutes after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare venous hematocrit and bilirubin values between the 2 groups.
Time Frame: 36-48 hs
venous hematocrit and bilirubin will be taken together with the sample taken for the mandatory neonatal screening.
36-48 hs

Collaborators and Investigators

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

Sponsor

Fundacion para la Salud Materno Infantil

Investigators

  • Principal Investigator: Nestor Vain, 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

August 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • funda04

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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