Clinical Trials Directory

Trials / Completed

CompletedNCT07084766

The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
University Hospital, Brest · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Intrauterine devices (IUDs) account for approximately 25% of contraceptive methods used in France. However, their insertion can be painful for patients and challenging for practitioners, particularly due to the passage through the cervix and the uterine flexion angle. An interventional study conducted by Cameron in 2013 examined the impact of bladder filling on the ease of IUD insertion. The results did not show a significant benefit, suggesting that a full bladder does not necessarily improve the procedure. An ongoing study, FLEXIMIX, led by the coordinator, explores the variation in the uterine flexion angle based on bladder filling in 250 nulliparous women. Preliminary results indicate a strong influence of bladder filling on the flexion angle. Additionally, the Valsalva maneuver, which involves increasing intra-abdominal pressure by forceful exhalation against a closed glottis, has been shown in two recent studies to facilitate gynecological interventions by improving cervical passage, thereby reducing the need for invasive instruments such as the tenaculum.What happens in parous women and during the Valsalva maneuver remains to be explored.

Conditions

Interventions

TypeNameDescription
PROCEDUREultrasonography, pelvicUltrasound measurements will be taken before and after bladder emptying. The axes of the uterine body, cervix and vagina will be marked out by tracing the 3 corresponding lines on the image.

Timeline

Start date
2025-09-25
Primary completion
2025-10-30
Completion
2025-10-30
First posted
2025-07-25
Last updated
2025-12-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07084766. Inclusion in this directory is not an endorsement.