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NCT02062801 · ClinicalTrials.gov registry record · Phase 4
Prophylactic Ephedrine and Combined Spinal Epidurals for Labor
A Phase 4 study, sponsored by Sharp HealthCare.
- Completed
- Registry status
- Phase 4
- Development phase
- 710
- Enrollment target
NCT02062801: Completed Phase 4 study, sponsored by Sharp HealthCare.
NCT02062801 is a Phase 4 study that has completed, run by Sharp HealthCare. The registered enrollment target is 710 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02062801, a Phase 4 study, has completed, sponsored by Sharp HealthCare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 710 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of early profound fetal bradycardia
Interventions
- DRUG Placebo
- DRUG Ephedrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
What the finished NCT02062801 record still lists
NCT02062801 is an interventional study that assigns participants to a tested intervention. The registered 710 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02062801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02062801 about?
NCT02062801 is a clinical study titled "Prophylactic Ephedrine and Combined Spinal Epidurals for Labor". 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 th...
What is the current status of trial NCT02062801?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 710 participants. The study started on 2012-01. Estimated completion is 2013-10.
What interventions are being tested in trial NCT02062801?
The interventions under investigation include: Placebo (DRUG), Ephedrine (DRUG).
Who is sponsoring clinical trial NCT02062801?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02062801's enrollment target sits among peer trials
710 114th of 2000 higher than 1,887 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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