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Clinical trialNCT02062801CompletedPhase 4Interventional

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

SponsorSharp HealthCareEnrollment710Labor Pain
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Sharp Mary Birch Hospital for Women and Newborns

    San Diego, California, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

EphedrinePlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2012
Primary completion
30 Apr 2013
Completion
31 Oct 2013
Last update posted
3 Jul 2015
Registered enrollment
710
Registry id
NCT02062801
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.