Performance of the Gynaecological Examination in the Lateral Decubitus Position (EXADELA)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Medical Care
• Intervention / Treatment: Procedure: gynaecological examination in lateral decubitus

• Study Type: Interventional
• Enrollment (Estimated): 564
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful	Procedure: gynaecological examination in lateral decubitus; Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinicians' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire	The questionnaire will be completed by the investigator during each visit.	1 day
patients' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire	The questionnaire will be completed by the patient during each visit.	1 day
The performance (success rate) of early examination (6 first examinations) will be evaluated for each practicioner.	Success rate in the first 6 patients of each practicioner. This result will allow us to know if the technique is accessible.	1 day
The occurrence of complications at 3 months during IUD insertion in the lateral position will be quantified	We will call each patient for follow-up at 3 months for patients with IUD insertion in the lateral position.	3 months
The predictive factors for failure of the lateral decubitus examination will be determined	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.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2021/0375/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No