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Oxytocin And Uterotonic Agent Use For Cesarean Delivery

NCT01549223 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-29

Study results available
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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

Conditions

Interventions

DRUG

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).

DRUG

Oxytocin Infusion

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Lawrence C Tsen, MD · Brigham and Women's Hospital/Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-01-31
Completion
2012-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549223 on ClinicalTrials.gov