Position at Birth,Placental Transfusion Volume and Cord Clamping

NCT01497340 | Terminated

• 1 other identifier: funda03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Delay Cord Clamping; Placental Trasfusion

Keywords

Cord clamping; newborn; Placental trasfusion; Delivery 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 peripherical 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 with a plastic clamp placed at 1 cm from its cutaneous insertion.

Other: 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 weight measurement. The cord will be clamped at 2 minutes after birth .

Other: Position at Maternal Abdomen

Interventions

Position at introitus level OTHER

After birth: Weight at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec Weight after clamping

Position at introitus level

Position at Maternal Abdomen OTHER

Newborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).

position at Maternal Abdomen

Eligibility Criteria

• Age: Up to 2 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term newborns, vigorous born by vaginal delivery, cephalic or vertex presentation.
• Signed informed consent.

You may not qualify if:

• History of Placenta previa,
• postpartum hemorrhage background, hemorrhage before 20- week- gestation.
• 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 .

Sponsors & Collaborators

• Fundacion para la Salud Materno Infantil: lead

Study Sites (1)

Hospital General de Agudos Juan A. Fernandez

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Location

Related Publications (14)

• 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: 17890882 BACKGROUND

• 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: 15541437 BACKGROUND

• 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: 16567393 BACKGROUND

• 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: 18425897 BACKGROUND

• 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: 16782490 BACKGROUND

• 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: 5321023 BACKGROUND

• 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: 17374818 BACKGROUND

• 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: 4588934 BACKGROUND

• 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: 16951036 BACKGROUND

• 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: 17636727 BACKGROUND

• Bystrova K, Widstrom AM, Matthiesen AS, Ransjo-Arvidson AB, Welles-Nystrom B, Wassberg C, Vorontsov I, Uvnas-Moberg K. Skin-to-skin contact may reduce negative consequences of "the stress of being born": a study on temperature in newborn infants, subjected to different ward routines in St. Petersburg. Acta Paediatr. 2003;92(3):320-6. doi: 10.1080/08035250310009248.

  PMID: 12725547 BACKGROUND

• 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: 4169972 BACKGROUND

• 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: 4186454 BACKGROUND

• 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

Study Officials

• Jorge Tavosnanska, MD

  HOSPITAL GENERAL DE AGUDOS JUAN A. FERNANDEZ

  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: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

AR (1)