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Position at Birth,Placental Transfusion Volume and Cord Clamping

This study has been terminated.
(difficulties with the center)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497340
First Posted: December 22, 2011
Last Update Posted: December 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundacion para la Salud Materno Infantil
  Purpose
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.

Condition Intervention
Delay Cord Clamping Placental Trasfusion Other: Position at introitus level Other: Position at Maternal Abdomen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study

Resource links provided by NLM:


Further study details as provided by Fundacion para la Salud Materno Infantil:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • To compare venous peripherical 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.


Enrollment: 27
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 with a plastic clamp placed at 1 cm from its cutaneous insertion.
Other: Position at introitus level
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
Experimental: position at Maternal Abdomen
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
Newborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).

Detailed Description:

Pilot study. Randomized controlled trial not blind, in one center. 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 with cord clamping at 2 minutes after birth. 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 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 obteined after clamping.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497340


Locations
Argentina
Hospital General de Agudos Juan A. Fernandez
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sponsors and Collaborators
Fundacion para la Salud Materno Infantil
Investigators
Principal Investigator: Jorge Tavosnanska, MD HOSPITAL GENERAL DE AGUDOS JUAN A. FERNANDEZ
  More Information

Publications:
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. Epub 2007 Sep 21. Review.
Diaz-Rossello JL. A difficult ethics issue. Lancet. 2004 Nov 13-19;364(9447):1751-2; author reply 1752.
Ceriani Cernadas JM, Carroli G, Pellegrini L, Otaño L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizábal 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. Epub 2006 Mar 27.
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. Review. Update in: Cochrane Database Syst Rev. 2013;7:CD004074.
Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Líz 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.
Lind J. Physiological adaptation to the placental transfusion: the eleventh blackader lecture. Can Med Assoc J. 1965 Nov 20;93(21):1091-100.
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. Review.
Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. Review.
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.
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. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD003519.
Bystrova K, Widström AM, Matthiesen AS, Ransjö-Arvidson AB, Welles-Nyström B, Wassberg C, Vorontsov I, Uvnäs-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.
Yao AC, Hirvensalo M, Lind J. Placental transfusion-rate and uterine contraction. Lancet. 1968 Feb 24;1(7539):380-3.
Yao AC, Moinian M, Lind J. Distribution of blood between infant and placenta after birth. Lancet. 1969 Oct 25;2(7626):871-3.
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.

Responsible Party: Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier: NCT01497340     History of Changes
Other Study ID Numbers: funda03
First Submitted: December 20, 2011
First Posted: December 22, 2011
Last Update Posted: December 22, 2011
Last Verified: December 2011

Keywords provided by Fundacion para la Salud Materno Infantil:
Cord clamping
newborn
Placental trasfusion
Delivery room


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