跳至主要内容
临床试验/NCT06009562
NCT06009562招募中不适用

Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study

University of Palermo1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年8月19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
28
试验地点
1
主要终点
continuation of pregnancy

研究概览

简要总结

The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.

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

  • The large and giant size of UFs, which prevent the proper continuation of pregnancy and/or occupy the entire small and large pelvis, as well as invade and/or occupy the abdominal cavity.
  • Circulatory disorders, evidenced by necrosis of the UFs.
  • Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of defecation, pelvic pain).

排除标准

  • Refusal of LPTM by the patient.
  • Absence of urgent indication for LPTM during pregnancy.

结局指标

主要结局

continuation of pregnancy

时间窗: 5 months

Pregnancy continuation after surgery.

次要结局

  • Fetal outcome(5 months)

研究者

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

Andrea Etrusco

M.D.

University of Palermo

研究点 (1)

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