Prospective Study of the Variation in the Angle of Anteflexion of the Uterus Before and After Micturition in Nulliparous Women With Uterine Anteversion.

NCT06669845 | Completed

• 2 other identifiers: 29BRC24.01242024-A01255-42
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

A monocentric, prospective, comparative, and descriptive clinical study examining the uterine anteflexion angle before and after bladder emptying in nulliparous women with uterine anteversion. The study aims to assess how bladder fullness affects the anteflexion angle, which may impact the ease of intrauterine device (IUD) insertion. The primary objective is to determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion. Ultrasound measurements will be taken before and after bladder emptying. A secondary objective is to determine the prevalence of uterine anteversion in nulliparous women.

Conditions

Uterine Anteflexion

Keywords

Uterine anteflexion; Nulliparous women; Full bladder; Ultrasound measurements

Outcome Measures

Primary Outcomes (1)

• To determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion.

  Difference between mean uterine anteflexion angle full bladder and empty bladder in nulliparous women with uterine anteversion.

  1 day

Study Arms (1)

Ultrasonography pelvic

OTHER

Ultrasound measurements before and after bladder emptying

Procedure: Ultrasonography, Pelvic

Interventions

Ultrasonography, Pelvic PROCEDURE

Ultrasound 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.

Ultrasonography pelvic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 and over;
• Nulliparous ;
• Feeling the need to urinate;
• Affiliated to a Social Security scheme.

You may not qualify if:

• Pregnant women;
• Desire of pregnancy with conception in progress;
• Primary amenorrhea ;
• Menopause ;
• Previous surgical termination of pregnancy;
• Previous medical abortion;
• Previous hysterectomy ;
• Previous conization;
• Absence of uterus;
• Irrepressible need to urinate;
• Inability or refusal to participate in the study.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 12, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)