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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Placental Transfusion Drug: Timing of administration of post partum Oxytocin Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Is Placental Transfusion Influenced by the Early Administration of Oxytocin?
Study Start Date : May 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Timing of administration of post partum Oxytocin
10 IU of oxytocin given IV at different times after birth
Other Name: syntosinon
Experimental: oxytocin at 3 minutes
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
10 IU of oxytocin given IV at different times after birth
Other Name: syntosinon


Outcome Measures
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Primary Outcome Measures :
  1. placental transfusion [ Time Frame: between birth and 3 minutes of life ]
    Difference in body weight between birth and 3 minutes of life


Secondary Outcome Measures :
  1. bilirubin [ Time Frame: at 36/48 hours ]
    Bilirubin level

  2. Hematocrit [ Time Frame: at 36/48 hours ]
    Hematocrit levels

  3. Maternal blood loss [ Time Frame: after birth for 30 minutes ]
    measure of the blood loss


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618499


Locations
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Argentina
Instituto de Ginecologia y Maternidad Nuestra Señora de la Merced
San Miguel de Tucuman, Tucuman, Argentina
Sponsors and Collaborators
Fundacion para la Salud Materno Infantil
Investigators
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Study Director: Nestor Vain, MD Fundasamin
Principal Investigator: Daniela S Satragno, MD Fundasamin
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier: NCT02618499    
Other Study ID Numbers: Funda05
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundacion para la Salud Materno Infantil:
birth
oxytocin
placental transfusion
umbilical cord clamping
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs