Oxytocin And Uterotonic Agent Use For Cesarean Delivery

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549223
• Other study ID #: 2010-P-002284
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2012
• Last updated: June 27, 2017
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Uterine Atony
• Uterine Inertia

Intervention

Drug:
• Oxytocin Infusion
500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
• 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).

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.	Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.	Up to 15 min from time of infant delivery
Secondary	Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use	Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.	Up to 15 min from time of infant delivery