Placental Transfusion Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | September 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 2 Minutes |
Eligibility |
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 . |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Argentina | Sanatorio de la Trinidad Palermo | Buenos Aires | Caba |
Argentina | Hospital Materno Infantil de San Isidro Dr. C. Gianantonio | San Isidro | Buenos Aires |
Argentina | Instituto de Meternidad y ginecología Nuestra señora de las Mercedes | San Miguel de Tucumán | Tucumán |
Lead Sponsor | Collaborator |
---|---|
Fundacion para la Salud Materno Infantil |
Argentina,
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. Pediatr — View Citation
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. — View Citation
Diaz-Rossello JL. A difficult ethics issue. Lancet. 2004 Nov 13-19;364(9447):1751-2; author reply 1752. — View Citation
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. — View Citation
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
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. — View Citation
Lind J. Physiological adaptation to the placental transfusion: the eleventh blackader lecture. Can Med Assoc J. 1965 Nov 20;93(21):1091-100. — View Citation
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 R — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Yao AC, Hirvensalo M, Lind J. Placental transfusion-rate and uterine contraction. Lancet. 1968 Feb 24;1(7539):380-3. — View Citation
Yao AC, Lind J. Placental transfusion. Am J Dis Child. 1974 Jan;127(1):128-41. Review. — View Citation
Yao AC, Moinian M, Lind J. Distribution of blood between infant and placenta after birth. Lancet. 1969 Oct 25;2(7626):871-3. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | To compare venous hematocrit and bilirubin values between the 2 groups. | venous hematocrit and bilirubin will be taken together with the sample taken for the mandatory neonatal screening. | 36-48 hs | Yes |
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