跳至主要内容
临床试验/NCT06110052
NCT06110052招募中不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
mullerian duct anomalies

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All cases with OMAs or H-OMAs

排除标准

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

结局指标

主要结局

mullerian duct anomalies

时间窗: 48 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Ali Mahmoud Mohamed

Principal Investigator

Assiut University

研究点 (1)

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