Position at Birth,Placental Transfusion Volume and Cord Clamping

This study has been terminated.
(difficulties with the center)
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier:
NCT01497340
First received: December 20, 2011
Last updated: December 21, 2011
Last verified: December 2011

December 20, 2011
December 21, 2011
October 2010
December 2010   (final data collection date for primary outcome 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. [ Time Frame: inmediately after birth until 2 minutes after birth ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01497340 on ClinicalTrials.gov Archive Site
To compare venous peripherical hematocrit and bilirubin values between the 2 groups . [ Time Frame: 36-48 hs ] [ Designated as safety issue: Yes ]
venous hematocrit and bilirubin will be taken together with the sample taken for the mandatory neonatal screening.
Same as current
Not Provided
Not Provided
 
Position at Birth,Placental Transfusion Volume and Cord Clamping
Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth? a Pilot Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Delay Cord Clamping
  • Placental Trasfusion
  • Other: 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
  • Other: 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).
  • Active Comparator: 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.
    Intervention: Other: Position at introitus level
  • Experimental: 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 .
    Intervention: Other: Position at Maternal Abdomen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
December 2010
December 2010   (final data collection date for primary outcome measure)

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 .
Both
up to 2 Minutes
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01497340
funda03
Not Provided
Fundacion para la Salud Materno Infantil
Fundacion para la Salud Materno Infantil
Not Provided
Principal Investigator: Jorge Tavosnanska, MD HOSPITAL GENERAL DE AGUDOS JUAN A. FERNANDEZ
Fundacion para la Salud Materno Infantil
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP