Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT07084766
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
The Variation in Uterine Flexion Angle Before and After Voiding in Parous Women.
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLEXIMIX 2
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID RCB | OTHER | 2025-A00826-43 | View |