NCT01549223

Oxytocin And Uterotonic Agent Use For Cesarean Delivery

A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will: 1\. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone. Secondary outcomes to be evaluated will be: 1. Reduce the side effects associated with uterotonic drug use 2. Reduce the time to establishment and maintenance of adequate uterine tone

Detailed description

The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents. More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.

Conditions

• Uterine Atony
• Hypotension

Interventions

Type	Name	Description
DRUG	Oxytocin Infusion	500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
DRUG	Oxytocin Bolus	3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2012-03-09
• Last updated: 2017-06-29
• Results posted: 2017-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study