Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

Cesarean Section During Labor Clinical Trial

— MODCL  

Official title:

Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02794779
• Other study ID #: anestesiatccthiago1416
• Status: Recruiting
• Phase: Phase 3
• First received: June 4, 2016
• Last updated: January 30, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Brasilia University Hospital
• Contact: Gabriel MN Guimaraes, MD, MSc
• Phone: +5561996455997
• Email: gabrielmng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Cesarean delivery during labor.

• Spinal anesthesia

Exclusion Criteria:

• Change of anesthesia

Related Conditions & MeSH terms

• Cesarean Section During Labor

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasília	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxytocin dose	Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.	10 minutes