Clinical trial NCT02618499: Delayed Cord Clamping and Use of Oxytocin
Official title: Is Placental Transfusion Influenced by the Early Administration of Oxytocin?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Placental Transfusion
Keywords: birth
oxytocin
placental transfusion
umbilical cord clamping
Lead sponsor: Fundacion para la Salud Materno Infantil
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy single Term pregnancies.
* Vaginal delivery.
* Informed consent obtained.
* Presence of an investigator

Exclusion Criteria:

* Placenta previa.
* 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

Primary outcomes:
measure: placental transfusion
timeFrame: between birth and 3 minutes of life
Secondary outcomes:
measure: bilirubin
timeFrame: at 36/48 hours
measure: Hematocrit
timeFrame: at 36/48 hours
measure: Maternal blood loss
timeFrame: after birth for 30 minutes
Other outcomes:
Locations:
city: San Miguel de Tucuman
country: Argentina
facility: Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced
state: Tucuman
Study officials:
affiliation: Fundasamin
name: Nestor Vain, MD
role: STUDY_DIRECTOR
affiliation: Fundasamin
name: Daniela S Satragno, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.