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Futility suggested by DSMC
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The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.
Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin inmediately at birth | Active Comparator | Intervention: Timing of administration of postpartum Oxytocin. 10 international Units (IU) immediately at birth will be given intravenously (IV) to the mother. |
|
| oxytocin at 3 minutes | Experimental | Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of administration of post partum Oxytocin | Drug | 10 IU of oxytocin given IV at different times after birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| placental transfusion | Difference in body weight between birth and 3 minutes of life | between birth and 3 minutes of life |
| Measure | Description | Time Frame |
|---|---|---|
| bilirubin | Bilirubin level | at 36/48 hours |
| Hematocrit | Hematocrit levels | at 36/48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Elimination criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestor Vain, MD | Fundasamin | Study Director |
| Daniela S Satragno, MD | Fundasamin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced | San Miguel de Tucumán | Tucumán Province | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23843134 | Background | 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. | |
| 24746755 | Background | 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. |
| Label | URL |
|---|---|
| WHO recommendations | View source |
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| ID | Term |
|---|---|
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Maternal blood loss | measure of the blood loss | after birth for 30 minutes |
| 24173606 | Background | 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. |
| 22502595 | Background | 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. |
| 20687079 | Background | 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. |
| 25730178 | Background | 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. |
| 4169972 | Background | 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. |
| 21083868 | Background | 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. |
| 4826961 | Background | 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. |
| 31072967 | Derived | 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. |
| D007232 |
| Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |