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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 4, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date January 31, 2017
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
Oxytocin dose [ Time Frame: 10 minutes ]
Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
Official Title  ICMJE Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Cesarean Section During Labor
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Oxytocin
  • Active Comparator: Continuous infusion
    Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.
    Intervention: Drug: Oxytocin
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 8, 2016)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cesarean delivery during labor.
  • Spinal anesthesia

Exclusion Criteria:

  • Change of anesthesia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 130 Years   (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 Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794779
Other Study ID Numbers  ICMJE anestesiatccthiago1416
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
Study Sponsor  ICMJE Brasilia University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brasilia University Hospital
Verification Date January 2017

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