Medical CareEXADELANCT05880290
Performance of the Gynaecological Examination in the Lateral Decubitus Position
A study testing gynaecological examination in lateral decubitus in people with Medical Care, run by University Hospital, Rouen at 21 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Care
- What is being tested?
- gynaecological examination in lateral decubitus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 21 sitesFrance
- Study dates
- 10 Jul 2023to 11 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
BIHOREL
Bihorel, 76420
Bois-Guillaume
Bois-Guillaume, 76230
BOOS 2
Boos, 76520
Le Havre 3
Le Havre, 76600
Le Havre 2
Le Havre, 76620
Le Havre 1
Le Havre
Lillebonne
Lillebonne, 76190
Louviers 1
Louviers, 27400
Louviers 2
Louviers, 27400
Louviers 3
Louviers, 27400
MALAUNAY
Malaunay, 76770
Montivillers 2
Montivilliers, 76290
Montivilliers 1
Montivilliers, 76290
Octeville Sur Mer
Octeville, 76930
Offranville
Offranville, 76550
ROUEN 4
Rouen, 76000
BOOS 1
Rouen, 76100
ROUEN 1
Rouen, 76100
ROUEN 2
Rouen, 76100
ROUEN 3
Rouen, 76100
YVETOT
Yvetot, 76190
About this study
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.
Read more
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
- Being tested
- gynaecological examination in lateral decubitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gynaecological examination in lateral decubitusProcedure or surgery
Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
| Study group | Role | What they receive |
|---|---|---|
| gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful | Experimental | Not described Receives: Procedure: gynaecological examination in lateral decubitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start10 Jul 2023
- Primary completion11 Apr 2026
- Study completion11 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
- Masking
- None (open label)
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880290
- Sponsor's protocol ID
- 2021/0375/HP
- Acronym
- EXADELA
- Status last verified
- May 2026
- First submitted
- 21 Mar 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Gynaecological Examination in the Lateral Decubitus Position
- ClinicalTrials.gov ID
- NCT05880290
- Acronym / sponsor ID
- EXADELA / 2021/0375/HP
- Conditions
- Medical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 11 Apr 2026 (actual)
- Study completion
- 11 Apr 2026 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful
| Arm | Type | Receives |
|---|---|---|
| gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful | Experimental | Procedure: gynaecological examination in lateral decubitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gynaecological examination in lateral decubitusSingle group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful | Procedure or surgery | gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful |
Primary outcome
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.
5 secondary outcomes
Clinicians' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
Time frame: 1 day
patients' satisfaction with lateral decubitus positioning for pelvic speculum examination will be evaluate with a questionnaire
Time frame: 1 day
The performance (success rate) of early examination (6 first examinations) will be evaluated for each practicioner.
Time frame: 1 day
The occurrence of complications at 3 months during IUD insertion in the lateral position will be quantified
Time frame: 3 months
The predictive factors for failure of the lateral decubitus examination will be determined
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gynaecological examination in lateral decubitus in people with Medical Care, run by University Hospital, Rouen at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.