Placental Transfusion and Cord Clamping

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier:
NCT01497353
First received: December 20, 2011
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Placental Transfusion
Procedure: Position at introitus level
Procedure: position at Maternal Abdomen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?

Resource links provided by NLM:


Further study details as provided by Fundacion para la Salud Materno Infantil:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • To compare venous 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.


Enrollment: 400
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. New weigh will be obtained after that.
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
Experimental: Position at Maternal Abdomen
The newborn will be placed on the abdomen and of the mother immediately after the first weigh measurement. The cord will be clamped at 2 minutes after birth .
Procedure: 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

Detailed 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).

  Eligibility

Ages Eligible for Study:   up to 2 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497353

Locations
Argentina
Hospital Materno Infantil de San Isidro Dr. C. Gianantonio
San Isidro, Buenos Aires, Argentina
Sanatorio de la Trinidad Palermo
Buenos Aires, Caba, Argentina
Instituto de Meternidad y ginecología Nuestra señora de las Mercedes
San Miguel de Tucumán, Tucumán, Argentina
Sponsors and Collaborators
Fundacion para la Salud Materno Infantil
Investigators
Principal Investigator: Nestor Vain, MD Fundasamin
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier: NCT01497353     History of Changes
Other Study ID Numbers: funda04
Study First Received: December 20, 2011
Last Updated: October 17, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Fundacion para la Salud Materno Infantil:
Cord clamping
newborn
Skin contact
Placental transfusion
Delivery room

ClinicalTrials.gov processed this record on September 30, 2014