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Clinical Trials/NCT06110052
NCT06110052
Recruiting
Not Applicable

Clinical Presentations and Surgical Outcome of Obstructive Müllerian Anomalies: A Prospective Cohort Study

Assiut University1 site in 1 country36 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mullerian Duct Anomalies
Sponsor
Assiut University
Enrollment
36
Locations
1
Primary Endpoint
mullerian duct anomalies
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The present study aims at:

A. The main outcome is to compare preoperative and postoperative visual analog scale VAS from 0 to 10 of maximum perceived pain in ladies with OMAs.

  1. description of clinical presentation and percentage of OMAs in relation to other Mullerian anomalies
  2. description of different subtypes and its percentage.
  3. description of the corrective procedures and their short-term outcomes.

Detailed Description

Obstructive Mullerian anomalies (OMAs) represent a real challenge in diagnosis and treatment, its incidence is not yet recognized. Care givers and gynecologist should be aware with its clinical presentation to avoid its delayed diagnosis and misdiagnosis. In addition, delayed diagnoses may result in retrograde menstruation, recurrent cyclic pains, chronic pelvic pains, poor quality of life and threats to future fertility. Cases with complete obstructive Müllerian anomalies (C-OMAs) classically present with recurrent cyclic pains at puberty and their diagnosis is usually established easily. However, cases with Hemi obstructive anomalies (H-OMA) usually present with progressive dysmenorrhea and delayed diagnosis may result in pelvic adhesions, progressive hematosalpinx and endometriosis which directly threats natural future fertility. H-OMAs may results from obstructing uterine septa or unilateral cervical obstruction in a double uterus. Also, it may result from obstructing longitudinal vaginal septa in cases with double uterus, septate uterus or hybrid septate uterus . A hybrid uterine anomaly is relatively a recent term that described the coexistence of septate and bicornuate uterus together. Pure septate uterus has a convex or flat fundus, when there is any fundal depression, it is termed hybrid septate uterus. Pain with or without amenorrhoea is the main presentation of OMAs. Surgical correction should improve these symptoms. To the best of our knowledge there is no published prospective trials compared visual analog scale VAS in ladies with OMAs before and after surgical correction.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Ali Mahmoud Mohamed

Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All cases with OMAs or H-OMAs

Exclusion Criteria

  • Cases who refuse to participate in the study. 2.Cases who underwent previous surgical repair for their OMA or H-OMA.

Outcomes

Primary Outcomes

mullerian duct anomalies

Time Frame: 48 months

A. The main outcome is to compare preoperative and postoperative visual analog scale VAS of maximum perceived pain in ladies with OMAs.

Study Sites (1)

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