Position at Birth,Placental Transfusion Volume and Cord Clamping

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study

Conditions
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Delay Cord Clamping, Placental Trasfusion

Intervention / Treatment
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* Other: Position at introitus level
* Other: Position at Maternal Abdomen


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Maximum Age: 2 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Position at introitus level<br>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<br>* 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<br>|
| Experimental: position at Maternal Abdomen<br>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<br>* Newborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare venous peripherical 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cord clamping, newborn, Placental trasfusion, Delivery room