Placental Transfusion and Cord Clamping
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|ClinicalTrials.gov Identifier: NCT01497353|
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : October 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Placental Transfusion||Procedure: Position at introitus level Procedure: position at Maternal Abdomen||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is the Placental Transfusion Volume Influenced by the Position of the New Born at Birth?|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
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
- 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 ]
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.
- To compare venous hematocrit and bilirubin values between the 2 groups. [ Time Frame: 36-48 hs ]venous hematocrit and bilirubin will be taken together with the sample taken for the mandatory neonatal screening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497353
|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|
|Principal Investigator:||Nestor Vain, MD||Fundasamin|