Oxytocin And Uterotonic Agent Use For Cesarean Delivery
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/7/2015 |
| Start Date: | April 2011 |
| End Date: | June 2016 |
| Contact: | Lawrence C Tsen, MD |
| Email: | ltsen@zeus.bwh.harvard.edu |
| Phone: | 617-732-8216 |
A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery
The central objective of this study will be to evaluate a standardized, evidence-based
regimen versus a conventional regimen for uterotonic drug dosing during cesarean delivery
The investigators primary hypothesis is that the proposed uterotonic drug regimen, when
compared to conventional dosing regimen, during 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
regimen versus a conventional regimen for uterotonic drug dosing during cesarean delivery
The investigators primary hypothesis is that the proposed uterotonic drug regimen, when
compared to conventional dosing regimen, during 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
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.
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.
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I or II health status
- Age between 18 and 50 yrs
- Singleton pregnancies in vertex position
- Elective (with or without prior labor) cesarean delivery with a planned lower uterine
(pfannenstiel) incision
Exclusion Criteria:
- Conditions that predispose to uterine atony and postpartum hemorrhage
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