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Delayed Cord Clamping and Use of Oxytocin

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

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE May 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delayed Cord Clamping and Use of Oxytocin
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Placental Transfusion
Intervention  ICMJE Drug: Timing of administration of post partum Oxytocin
10 IU of oxytocin given IV at different times after birth
Other Name: syntosinon
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 22, 2016)
180
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2015)
550
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618499
Other Study ID Numbers  ICMJE Funda05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fundacion para la Salud Materno Infantil
Study Sponsor  ICMJE Fundacion para la Salud Materno Infantil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP