Delayed Cord Clamping and Use of Oxytocin

• ClinicalTrials.gov Identifier: NCT02618499
• Recruitment Status: Terminated
• First Posted: December 1, 2015
• Last Update Posted: November 23, 2016
• Sponsor: Fundacion para la Salud Materno Infantil
• Information provided by (Responsible Party): Fundacion para la Salud Materno Infantil

Tracking Information

• First Submitted Date: November 10, 2015
• First Posted Date: December 1, 2015
• Last Update Posted Date: November 23, 2016
• Study Start Date: May 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 27, 2015)

placental transfusion [ Time Frame: between birth and 3 minutes of life ]

Difference in body weight between birth and 3 minutes of life

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 27, 2015)

• bilirubin [ Time Frame: at 36/48 hours ]
  Bilirubin level
• Hematocrit [ Time Frame: at 36/48 hours ]
  Hematocrit levels
• Maternal blood loss [ Time Frame: after birth for 30 minutes ]
  measure of the blood loss

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Delayed Cord Clamping and Use of Oxytocin
• Official Title: Is Placental Transfusion Influenced by the Early Administration of Oxytocin?
• 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
• Condition: Placental Transfusion

Intervention

Drug: Timing of administration of post partum Oxytocin

10 IU of oxytocin given IV at different times after birth

Other Name: syntosinon

Study Arms

• Active Comparator: 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.
  Intervention: Drug: Timing of administration of post partum Oxytocin
• Experimental: oxytocin at 3 minutes
  Intervention: Timing of administration of postpartum Oxytocin. 10 IU IV at 3 minutes immediately after the cord is clamped
  Intervention: Drug: Timing of administration of post partum Oxytocin

Publications *

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 22, 2016): 180
• Original Estimated Enrollment (submitted: November 27, 2015): 550
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina

Administrative Information

• NCT Number: NCT02618499
• Other Study ID Numbers: Funda05
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fundacion para la Salud Materno Infantil
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundacion para la Salud Materno Infantil
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Nestor Vain, MD; Fundasamin
• Principal Investigator: Daniela S Satragno, MD; Fundasamin

• PRS Account: Fundacion para la Salud Materno Infantil
• Verification Date: November 2016