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Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

NCT02062801 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2015-07-03

Study results available
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Summary

The combined spinal epidural (CSE) technique has become increasingly popular for labor pain because of its rapid onset and superior first stage analgesia. However, increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of CSE administration during labor. The purpose of this study is to measure the incidence of EPFB after combined spinal epidural analgesia using standard definitions. The incidence of EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the time of CSE placement.

Conditions

  • Labor Pain

Interventions

DRUG

Ephedrine

Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea

DRUG

Placebo

Patients received normal saline (placebo) administered immediately after combined spinal epidural (CSE) placement

Sponsors & Collaborators

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • David R Gambling, MB,BS · Anesthesia Services Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02062801 on ClinicalTrials.gov