Position at Birth,Placental Transfusion Volume and Cord Clamping
NCT ID: NCT01497340
Last Updated: 2011-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
27 participants
INTERVENTIONAL
2010-10-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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 .
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).
Interventions
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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
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).
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent.
Exclusion Criteria
* 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 .
2 Minutes
ALL
Yes
Sponsors
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Fundacion para la Salud Materno Infantil
OTHER
Responsible Party
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Principal Investigators
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Jorge Tavosnanska, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL GENERAL DE AGUDOS JUAN A. FERNANDEZ
Locations
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Hospital General de Agudos Juan A. Fernandez
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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funda03
Identifier Type: -
Identifier Source: org_study_id