Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

NCT ID: NCT03436888

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-15

Study Completion Date

2023-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Girdle Pain Pregnancy Related Postpartum Period

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system.

Exclusion Criteria

* Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pôle de Santé de la Grâce de Dieu

Caen, , France

Site Status

Caen University Hospital

Caen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A00949-44

Identifier Type: -

Identifier Source: org_study_id