Phase 4 Completed N=60 Randomized Quadruple-blind Treatment

Oxytocin And Uterotonic Agent Use For Cesarean Delivery

uterine atony · Hypotension

Source: ClinicalTrials.gov NCT01549223 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

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

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.