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Oxytocin in Cesarean Delivery

NCT01236482 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-11-08

No results posted yet for this study

Summary

In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. In order to perform this study the investigators perform the following steps:

1. The investigators validate a quantitative measure of uterine tone as our primary endpoint.
2. The investigators use this endpoint measure in order to determine equipotential doses of different tocotonic drug regimens, based on the ED50 for each.
3. Using equipontial ratios based on the ED50, the investigators compare hemodynamic and other side effects of these tocotonic drug regimes. Plasma levels of oxytocin will be measured.

Conditions

  • Post Partum Hemorrhage

Interventions

DRUG

Oxytocin versus oxytocin-ergometrine

Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Israel

Study Locations

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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 NCT01236482 on ClinicalTrials.gov