Delayed Cord Clamping and Use of Oxytocin

NCT02618499 | Terminated Phase 3 DMC

• 1 other identifier: Funda05
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Placental Transfusion

Keywords

birth; oxytocin; placental transfusion; umbilical cord clamping

Outcome Measures

Primary Outcomes (1)

• placental transfusion

  Difference in body weight between birth and 3 minutes of life

  between birth and 3 minutes of life

Secondary Outcomes (3)

• bilirubin

  at 36/48 hours

• Hematocrit

  at 36/48 hours

• Maternal blood loss

  after birth for 30 minutes

Study Arms (2)

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.

Drug: Timing of administration of post partum Oxytocin

oxytocin at 3 minutes

EXPERIMENTAL

Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped

Drug: Timing of administration of post partum Oxytocin

Interventions

Timing of administration of post partum Oxytocin DRUG

10 IU of oxytocin given IV at different times after birth

Also known as: syntosinon

oxytocin at 3 minutes; oxytocin inmediately at birth

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Salud Materno Infantil: lead

Study Sites (1)

Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Related Publications (10)

• 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.

  PMID: 23843134 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.

  PMID: 24746755 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.

  PMID: 24173606 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.

  PMID: 22502595 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.

  PMID: 20687079 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.

  PMID: 25730178 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.

  PMID: 4169972 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.

  PMID: 21083868 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.

  PMID: 4826961 BACKGROUND

• 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.

  PMID: 31072967 DERIVED

Related Links

• WHO recommendations

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nestor Vain, MD

  Fundasamin

  STUDY DIRECTOR

• Daniela S Satragno, MD

  Fundasamin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: December 1, 2015
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)