NCT04056403

Brief Summary

To compare the labor epidural analgesic (EA) profiles between landmark insertion EA levels which are congruent and ingruent to ultrasound confirmation in lateral decubitus position.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

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

August 1, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 7, 2019

Last Update Submit

August 12, 2019

Conditions

Parturient

Keywords

labor epiduralultrasound

Outcome Measures

Primary Outcomes (1)

  • Accuracy of landmark epidural level

    Validation of landmark localization of epidural insertion level by using ultrasound examination

    10 minute

Secondary Outcomes (1)

  • Labor analgesic dose

    one day

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Parturient who receive labor epidural

You may qualify if:

  • Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor
  • Using patient-controlled epidural analgesia

You may not qualify if:

  • who has an accidental epidural puncture
  • who receives epidural insertion by ultrasound identification
  • who uses of magnesium sulfate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Wu

CONTACT

0972653376longersolo@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 14, 2019

Study Start

August 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

TW(1)