Performance of the Gynaecological Examination in the Lateral Decubitus Position

NCT ID: NCT05880290

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 564 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

Group Type: EXPERIMENTAL

gynaecological examination in lateral decubitus

Intervention Type: PROCEDURE

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

Interventions

gynaecological examination in lateral decubitus

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2021/0375/HP

Identifier Type: -

Identifier Source: org_study_id