Clinical trial NCT01497340: Position at Birth,Placental Transfusion Volume and Cord Clamping
Official title: Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delay Cord Clamping
Placental Trasfusion
Keywords: Cord clamping
newborn
Placental trasfusion
Delivery room
Lead sponsor: Fundacion para la Salud Materno Infantil
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 27
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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 .

Primary outcomes:
measure: 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.
timeFrame: inmediately after birth until 2 minutes after birth
Secondary outcomes:
measure: To compare venous peripherical hematocrit and bilirubin values between the 2 groups .
timeFrame: 36-48 hs
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital General de Agudos Juan A. Fernandez
state: Buenos Aires
Study officials:
affiliation: HOSPITAL GENERAL DE AGUDOS JUAN A. FERNANDEZ
name: Jorge Tavosnanska, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1159/000108764. Epub 2007 Sep 21.
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citation: 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.
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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. doi: 10.1542/peds.2006-1053. No abstract available.
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citation: 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.
citation: 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.
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