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Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial (MODCL)

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ClinicalTrials.gov Identifier: NCT02794779
Recruitment Status : Unknown
Verified January 2017 by Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital.
Recruitment status was:  Recruiting
First Posted : June 9, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Brief Summary:

Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses threaten the life of women.

Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.

Method: adaptative clinical trial using a modified up and down method of two sequential groups: rule of three and continuous infusion. Allocation in rule of three or continuous infusion will be random and masked for patients and anesthesiologists. The minimum effective dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).


Condition or disease Intervention/treatment Phase
Cesarean Section During Labor Drug: Oxytocin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Rule of three
Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.
Drug: Oxytocin
Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.

Active Comparator: Continuous infusion
Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.
Drug: Oxytocin
Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.




Primary Outcome Measures :
  1. Oxytocin dose [ Time Frame: 10 minutes ]
    Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cesarean delivery during labor.
  • Spinal anesthesia

Exclusion Criteria:

  • Change of anesthesia

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): NCT02794779


Contacts
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Contact: Gabriel MN Guimaraes, MD, MSc +5561996455997 gabrielmng@gmail.com
Contact: Helga BG Silva, MD, PhD 5561991755997 helgabgs@gmail.com

Locations
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Brazil
Hospital Universitário de Brasília Recruiting
Brasilia, Distrito Federal, Brazil, 70000000
Contact: Gabriel MN Guimaraes, MD MsC    6196455997    gabrielmng@gmail.com   
Sponsors and Collaborators
Brasilia University Hospital
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Responsible Party: Gabriel Magalhaes Nunes Guimaraes, MD, MSc, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT02794779    
Other Study ID Numbers: anestesiatccthiago1416
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital:
cesarean section
labor
oxytocin
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs