Clinical trial NCT01549223: Oxytocin And Uterotonic Agent Use For Cesarean Delivery
Official title: A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Atony
Hypotension
Keywords: Uterine Atony
Hypotension
Cesarean Delivery
Hemorrhage
Phenylephrine
Ephedrine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I or II health status
* Age between 18 and 50 yrs
* Singleton pregnancies in vertex position
* Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision

Exclusion Criteria:

* Conditions that predispose to uterine atony and postpartum hemorrhage

Primary outcomes:
measure: 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.
timeFrame: Up to 15 min from time of infant delivery
Secondary outcomes:
measure: Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use
timeFrame: Up to 15 min from time of infant delivery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Lawrence C Tsen, MD
role: PRINCIPAL_INVESTIGATOR
References: