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

May 26, 2025 updated by: University Hospital, Brest
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasonography pelvic
Ultrasound measurements before and after bladder emptying
Procedure: Ultrasonography, Pelvic
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion.
Time Frame: 1 day
Difference between mean uterine anteflexion angle full bladder and empty bladder in nulliparous women with uterine anteversion.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29BRC24.0124
  • 2024-A01255-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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