Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
180 participants
INTERVENTIONAL
2016-05-31
2016-11-30
Brief Summary
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Detailed Description
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Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.
The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.
In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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oxytocin inmediately at birth
Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother.
Timing of administration of post partum Oxytocin
10 IU of oxytocin given IV at different times after birth
oxytocin at 3 minutes
Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped
Timing of administration of post partum Oxytocin
10 IU of oxytocin given IV at different times after birth
Interventions
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Timing of administration of post partum Oxytocin
10 IU of oxytocin given IV at different times after birth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vaginal delivery.
* Informed consent obtained.
* Presence of an investigator
Exclusion Criteria
* Previous history of Postpartum hemorrhage
* Intrauterine growth restriction .
* Major congenital malformations.
* Eclampsia
* 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
* Surgically finished delivery
* Short umbilical cord which might prevent placing the infant on the scale
* Technical difficulties to obtain the weight
ALL
No
Sponsors
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Fundacion para la Salud Materno Infantil
OTHER
Responsible Party
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Principal Investigators
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Nestor Vain, MD
Role: STUDY_DIRECTOR
Fundasamin
Daniela S Satragno, MD
Role: PRINCIPAL_INVESTIGATOR
Fundasamin
Locations
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Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced
San Miguel de Tucumán, Tucumán Province, Argentina
Countries
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References
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McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
Vain NE, Satragno DS, Gorenstein AN, Gordillo JE, Berazategui JP, Alda MG, Prudent LM. Effect of gravity on volume of placental transfusion: a multicentre, randomised, non-inferiority trial. Lancet. 2014 Jul 19;384(9939):235-40. doi: 10.1016/S0140-6736(14)60197-5. Epub 2014 Apr 17.
Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Oct 30;(10):CD001808. doi: 10.1002/14651858.CD001808.pub2.
Lalonde A; International Federation of Gynecology and Obstetrics. Prevention and treatment of postpartum hemorrhage in low-resource settings. Int J Gynaecol Obstet. 2012 May;117(2):108-18. doi: 10.1016/j.ijgo.2012.03.001. No abstract available.
Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
Begley CM, Gyte GM, Devane D, McGuire W, Weeks A. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2015 Mar 2;(3):CD007412. doi: 10.1002/14651858.CD007412.pub4.
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.
Farrar D, Airey R, Law GR, Tuffnell D, Cattle B, Duley L. Measuring placental transfusion for term births: weighing babies with cord intact. BJOG. 2011 Jan;118(1):70-5. doi: 10.1111/j.1471-0528.2010.02781.x. Epub 2010 Nov 18.
Trudnowski RJ, Rico RC. Specific gravity of blood and plasma at 4 and 37 degrees C. Clin Chem. 1974 May;20(5):615-6. No abstract available.
Vain NE, Satragno DS, Gordillo JE, Fernandez AL, Carrolli G, Romero NP, Prudent LM. Postpartum use of oxytocin and volume of placental transfusion: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):14-17. doi: 10.1136/archdischild-2018-316649. Epub 2019 May 9.
Related Links
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WHO recommendations
Other Identifiers
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Funda05
Identifier Type: -
Identifier Source: org_study_id