Performance of the Gynaecological Examination in the Lateral Decubitus Position
EXADELA
1 other identifier
interventional
564
1 country
21
Brief Summary
The gynaecological examination consists of a breast examination, abdominal examination, inspection of the vulva, vaginal touch and pelvic examination with a speculum. The latter is essential for the insertion and removal of intrauterine devices (IUDs), for the diagnosis and screening of pathologies that may cause pelvic symptoms, for assessment of the vaginal wall and for regular screening for cervical cancer. The gynaecological examination is feared by many women because of the feeling of exposure, vulnerability and loss of control. The parallel with a sexual position is particularly disturbing for patients who do not want to see this representation mixed with a medical necessity, which can lead some women to have irregular or even discontinued follow-up. For the past ten years, medical practice theses and midwifery dissertations have evaluated the interest of another position for the pelvic examination with the speculum : the lateral decubitus position in which the patient lies on her side. The lateral decubitus pelvic examination seems to be an alternative for comfort and respect for modesty, which is favoured by the patients. This examination position would have advantages in situations of anterior anatomical position of the position of the cervix, prolapse, severe obesity, hip pathology or significant reluctance to the examination. The effectiveness of this technique in terms of examination performance needs to be evaluated to promote its dissemination. The impact of an examination that is better experienced by patients is that of better adherence and therefore better follow-up, which is the particular challenge of primary care. Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedStudy Start
First participant enrolled
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 17, 2026
February 1, 2026
3.3 years
March 21, 2023
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Gynaecological speculum examination in the lateral decubitus position will be perform during the visit to assess if the performance is sufficient to be offered as an alternative to the examination in the conventional position.
Examination realize during the visit of the patient.
1 day
Secondary Outcomes (5)
Clinicians' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
1 day
patients' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
1 day
The performance (success rate) of early examination (6 first examinations) will be evaluated for each practicioner.
1 day
The occurrence of complications at 3 months during IUD insertion in the lateral position will be quantified
3 months
The predictive factors for failure of the lateral decubitus examination will be determined
1 day
Study Arms (1)
gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
EXPERIMENTALInterventions
Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
Eligibility Criteria
You may qualify if:
- Woman of legal age, 18 years or older.
- Who already had a gynaecological examination in the conventional position.
- Requiring a gynaecological consultation in primary care with speculum for screening, diagnosis or prevention.
- Woman of childbearing age with a negative urine pregnancy test or postmenopausal woman (no period in the last 12 months).
- Patient who has read and understood the information letter and signed the consent form.
- Affiliated to the social security.
You may not qualify if:
- Pregnant woman
- Who already participated to this protocol
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / sub-guardianship or curatorship.
- Major cognitive impairment that prevents the subject from fully understanding the requirements for participation in the study or from giving informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
BIHOREL
Bihorel, 76420, France
Bois-Guillaume
Bois-Guillaume, 76230, France
BOOS 2
Boos, 76520, France
Le Havre 3
Le Havre, 76600, France
Le Havre 2
Le Havre, 76620, France
Le Havre 1
Le Havre, France
Lillebonne
Lillebonne, 76190, France
Louviers 1
Louviers, 27400, France
Louviers 2
Louviers, 27400, France
Louviers 3
Louviers, 27400, France
MALAUNAY
Malaunay, 76770, France
Montivillers 2
Montivilliers, 76290, France
Montivilliers 1
Montivilliers, 76290, France
Octeville Sur Mer
Octeville, 76930, France
Offranville
Offranville, 76550, France
ROUEN 4
Rouen, 76000, France
BOOS 1
Rouen, 76100, France
ROUEN 1
Rouen, 76100, France
ROUEN 2
Rouen, 76100, France
ROUEN 3
Rouen, 76100, France
YVETOT
Yvetot, 76190, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2023
First Posted
May 30, 2023
Study Start
July 10, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02