Placental Transfusion and Cord Clamping

Placental Transfusion Clinical Trial

Official title:

Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497353
• Other study ID #: funda04
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: October 17, 2012
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Fundacion para la Salud Materno Infantil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Description:

No inferiority, Randomized controlled trial not blind, Multicenter. 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 will be included. 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 obtained after clamping.

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).

Recruitment information / eligibility

• 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 .

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Placental Transfusion

Intervention

Procedure:
• Position at introitus level
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 Maternal Abdomen
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Salud Materno Infantil

Country where clinical trial is conducted

Argentina, 

References & Publications (14)

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

Outcome

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