NCT06085027

Brief Summary

The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are:

  • Whether it consume less time identifying epidural space with the Epifaith® syringe
  • Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 11, 2023

Last Update Submit

October 11, 2023

Conditions

Epidural; Anesthesia, HeadacheAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Time consumed to identify the epidural space

    Starting on the moment which the syringe be attached to the needle

    During the procedure

Study Arms (2)

The Epifaith® syringe

EXPERIMENTAL
Procedure: Labor analgesia

The plastic syringe

ACTIVE COMPARATOR
Procedure: Labor analgesia

Interventions

Labor analgesiaPROCEDURE

Perform epidrual analgesia for parturients between 18 to 45 year-old

The Epifaith® syringeThe plastic syringe

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA II to III
  • Require labor analgesia
  • Has submitted inform consent

You may not qualify if:

  • ASA IV or above
  • Coagulopathy
  • Spinal deformity
  • Neurological, psychological, cardiopulmonary disorder
  • Active liver or kidney injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HeadacheAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Sheng Yang, MD

CONTACT

+886978989351chubbyming20@cgmh.org.tw

Rou-Yan Lin, MD

CONTACT

+886978989198emily920703@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 16, 2023

Study Start

October 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

October 16, 2023

Record last verified: 2023-10