Performance of the Gynaecological Examination in the Lateral Decubitus Position

NCT05880290 | Completed

• 1 other identifier: 2021/0375/HP
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 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

Conditions

Medical Care

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

EXPERIMENTAL

Procedure: gynaecological examination in lateral decubitus

Interventions

gynaecological examination in lateral decubitus PROCEDURE

Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (21)

BIHOREL

Bihorel, 76420, France

Location

Bois-Guillaume

Bois-Guillaume, 76230, France

Location

BOOS 2

Boos, 76520, France

Location

Le Havre 3

Le Havre, 76600, France

Location

Le Havre 2

Le Havre, 76620, France

Location

Le Havre 1

Le Havre, France

Location

Lillebonne

Lillebonne, 76190, France

Location

Louviers 1

Louviers, 27400, France

Location

Louviers 2

Louviers, 27400, France

Location

Louviers 3

Louviers, 27400, France

Location

MALAUNAY

Malaunay, 76770, France

Location

Montivillers 2

Montivilliers, 76290, France

Location

Montivilliers 1

Montivilliers, 76290, France

Location

Octeville Sur Mer

Octeville, 76930, France

Location

Offranville

Offranville, 76550, France

Location

ROUEN 4

Rouen, 76000, France

Location

BOOS 1

Rouen, 76100, France

Location

ROUEN 1

Rouen, 76100, France

Location

ROUEN 2

Rouen, 76100, France

Location

ROUEN 3

Rouen, 76100, France

Location

YVETOT

Yvetot, 76190, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 30, 2023
• Study Start: July 10, 2023
• Primary Completion: April 11, 2026
• Study Completion: April 11, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

FR (21)