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Completed

NCT Number: NCT01177046

Development of a Multi-attribute Health Index: to Measure the Quality of Labour Analgesia: The QLA Index

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

About this study

The current lack of a tool to measure the overall quality of neuraxial pain relief provided in labour analgesia trials has produced studies unable to provide clear direction to clinical care and research. Our previous work explored and described the underlying dimensions and attributes of quality neuraxial analgesia from the perspectives of labouring women as the initial phase of development of an Index to measure this as an outcome in research. We now seek to confirm our findings as well as to generate additional items (descriptors) of quality neuraxial analgesia from the perspectives of parturients and experts (obstetrical anesthesiologists and experienced labour nurses). Once generated, the full list of items will be used to in a subsequent study involving only parturients (Item Reduction phase) to develop a scale permitting global measurement of quality neuraxial labour analgesia. The resulting scale, once validated, will provide researchers with a simple global measure for quality in labour analgesia research. This scale will be used later in our program of research to assist with validation studies of the larger Multi-attribute Health Index we are developing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Psychometric instrument development study

    Time frame: 5-6 years

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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Development of a Multi-attribute Health Index to Measure the Quality of Labour Analgesia: Psychometric Development of a Quality of Neuraxial Labour Analgesia Scale

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2010
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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