NCT01177046

Brief Summary

The findings of this research will be used to develop a scale for measuring the quality of epidural pain relief achieved during labour and vaginal delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
752

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

11.3 years

First QC Date

August 4, 2010

Last Update Submit

June 8, 2022

Conditions

Labour Pain

Keywords

Women receiving labour epidural for most recent delivery

Outcome Measures

Primary Outcomes (1)

  • Psychometric instrument development study

    Exploration and description of language, nature, and variability of women's pain experiences during labour and delivery.

    5-6 years

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who received neuraxial labour analgesia during the current pregnancy

You may qualify if:

  • Use of neuraxial labour analgesia during the current pregnancy
  • Native English-speakers
  • Term pregnancies (\>37-42weeks)
  • The ability to read and write in English
  • Provision of written informed consent.

You may not qualify if:

  • Women who received IM or IV narcotics within 4 hours of epidural/ combined spinal epidural (CSE) placement
  • Women with evidence or history of maternal cognitive impairment
  • Women who experienced a neonatal death during the current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Pamela Angle, MD, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 6, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations

CA(1)