Phase 4 N=60 Randomized Quadruple-blind Treatment

Oxytocin And Uterotonic Agent Use For Cesarean Delivery

Uterine Atony · Hypotension

Bottom Line

View on ClinicalTrials.gov: NCT01549223 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. — 8.4; 4.0 IU

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oxytocin Infusion (Drug); Oxytocin Bolus (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Brigham and Women's Hospital
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.	8.4; 4.0	—
SECONDARY Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use	3; 2	—

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

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

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Data sourced from ClinicalTrials.gov (NCT01549223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.