NCT01497353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

December 20, 2011

Last Update Submit

October 17, 2012

Conditions

Placental Transfusion

Keywords

Cord clampingnewbornSkin contactPlacental transfusionDelivery room

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (1)

  • To compare venous hematocrit and bilirubin values between the 2 groups.

    36-48 hs

Study Arms (2)

Position at introitus level

ACTIVE COMPARATOR

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

Position at Maternal Abdomen

EXPERIMENTAL

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

Interventions

Position at introitus levelPROCEDURE

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

Position at introitus level
position at Maternal AbdomenPROCEDURE

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

Position at Maternal Abdomen

Eligibility Criteria

AgeUp to 2 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Materno Infantil de San Isidro Dr. C. Gianantonio

San Isidro, Buenos Aires, Argentina

Location

Sanatorio de la Trinidad Palermo

Buenos Aires, Buenos Aires F.D., Argentina

Location

Instituto de Meternidad y ginecología Nuestra señora de las Mercedes

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Related Publications (15)

  • Fonseca D. Importancia del aporte de sangre placentaria al niño recién nacido. Su medida por medio del registro ponderal continuo.Arch. Pediatr.Uruguay 1962; 7: 444

    BACKGROUND

  • Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.

    PMID: 17890882RESULT

  • Diaz-Rossello JL. A difficult ethics issue. Lancet. 2004 Nov 13-19;364(9447):1751-2; author reply 1752. doi: 10.1016/S0140-6736(04)17385-6. No abstract available.

    PMID: 15541437RESULT

  • Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.

    PMID: 16567393RESULT

  • McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2.

    PMID: 18425897RESULT

  • Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Effect of timing of umbilical cord clamping on iron status in Mexican infants: a randomised controlled trial. Lancet. 2006 Jun 17;367(9527):1997-2004. doi: 10.1016/S0140-6736(06)68889-2.

    PMID: 16782490RESULT

  • Lind J. Physiological adaptation to the placental transfusion: the eleventh blackader lecture. Can Med Assoc J. 1965 Nov 20;93(21):1091-100. No abstract available.

    PMID: 5321023RESULT

  • Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.

    PMID: 17374818RESULT

  • Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. doi: 10.1001/archpedi.1974.02110200130021. No abstract available.

    PMID: 4588934RESULT

  • van Rheenen PF, Brabin BJ. Effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Sep;118(3):1317-8; author reply 1318-9. doi: 10.1542/peds.2006-1053. No abstract available.

    PMID: 16951036RESULT

  • Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003519. doi: 10.1002/14651858.CD003519.pub2.

    PMID: 17636727RESULT

  • Yao AC, Hirvensalo M, Lind J. Placental transfusion-rate and uterine contraction. Lancet. 1968 Feb 24;1(7539):380-3. doi: 10.1016/s0140-6736(68)91352-4. No abstract available.

    PMID: 4169972RESULT

  • Yao AC, Moinian M, Lind J. Distribution of blood between infant and placenta after birth. Lancet. 1969 Oct 25;2(7626):871-3. doi: 10.1016/s0140-6736(69)92328-9. No abstract available.

    PMID: 4186454RESULT

  • Farrar D, Airey R, Law GR, Tuffnell D, Cattle B, Duley L. Measuring placental transfusion for term births: weighing babies with cord intact. BJOG. 2011 Jan;118(1):70-5. doi: 10.1111/j.1471-0528.2010.02781.x. Epub 2010 Nov 18.

    PMID: 21083868RESULT

  • Vain NE, Satragno DS, Gorenstein AN, Gordillo JE, Berazategui JP, Alda MG, Prudent LM. Effect of gravity on volume of placental transfusion: a multicentre, randomised, non-inferiority trial. Lancet. 2014 Jul 19;384(9939):235-40. doi: 10.1016/S0140-6736(14)60197-5. Epub 2014 Apr 17.

    PMID: 24746755DERIVED

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nestor Vain, MD

    Fundasamin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations

AR(3)