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Completed

NCT Number: NCT05880290

Performance of the Gynaecological Examination in the Lateral Decubitus Position

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BIHOREL, Bihorel, France

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

gynaecological examination in lateral decubitus

Procedure

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

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.

    Time frame: 1 day

    Examination realize during the visit of the patient.

Secondary outcomes

  1. Clinicians' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire

    Time frame: 1 day

    The questionnaire will be completed by the investigator during each visit.

  2. patients' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire

    Time frame: 1 day

    The questionnaire will be completed by the patient during each visit.

  3. The performance (success rate) of early examination (6 first examinations) will be evaluated for each practicioner.

    Time frame: 1 day

    Success rate in the first 6 patients of each practicioner. This result will allow us to know if the technique is accessible.

  4. The occurrence of complications at 3 months during IUD insertion in the lateral position will be quantified

    Time frame: 3 months

    We will call each patient for follow-up at 3 months for patients with IUD insertion in the lateral position.

  5. The predictive factors for failure of the lateral decubitus examination will be determined

    Time frame: 1 day

    Age (years), weight (kg) and reason for speculum exam (IUD placement, pelvic pain, vaginal discomfort) will be collected and correlated. This information will make it possible to define a population at risk of failure of the examination in lateral decubitus.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EXADELA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 30, 2023
Registry last updated
May 11, 2026

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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