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临床试验/NCT07293169
NCT07293169尚未招募不适用

H.Pylori Infection Among Women With Recurrent Abortion of Unknown Cause

Assiut University0 个研究点目标入组 100 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause

研究概览

简要总结

  • Helicobacter pylori (H. pylori) infection affects approximately one half of the world population and it is more prevalent in developing countries. This microorganism colonizes the stomach. Typically, it is acquired during childhood and causes asymptomatic chronic infection. A small portion of H. pylori infected subjects develop peptic ulcers and gastric carcinoma, usually during late adulthood. (1,2)
  • Some studies show a relationship between H.pylori and pregnancy-related disorders, such as fetal growth defects and malformations, miscarriage and, more recently, to pre-eclampsia. (3)
  • Abortion is one of the most common complications of pregnancy. Infection is one of the main causes of abortion, a cause which is more important in spontaneous abortion; infections account for only 5% of recurrent abortions. (4)
  • The severity of infection with H.pylori: given the increasing secretion of inflammatory cytokines and CD8 +, CD4 + in T cells and increasing interferons (IFN), studies have shown that infection with Helicobacter pylori activates immune cells in the uterus and endometrial surface cells, increases TH1 response to helicobacter, disturbs the ratio of T-Helper 2 / T-Helper 1 cytokines, causes abnormalities in the formation of natural vessels in the uterus and, ultimately, leads to abortion.(5)
  • Repeated spontaneous abortion (RSA): >=2 consecutive spontaneous pregnancy losses before 20 weeks gestation.(6)
  • To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause........

详细描述

3.Patients and methods

Study design:

Case Control study two groups (one group of 50 women with history of recurrent abortion and another group of 50 women without recurrent of abortion)

Study location:

the study will be conducted in Assiut university hospitals (women's health hospital) .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Known uterine anatomical causes of abortion.
  • Current systemic antibiotic use and PPIs within 2 weeks.
  • Medical diseases as (Thyroid disorders , DM,HTN).
  • Antiphspholipid syndrome.

结局指标

主要结局

• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause

时间窗: baseline

H.pylori infection among women with recurrent abortion of unknown cause

时间窗: the study will be carried out from October 2025 till October 2026

• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause........

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

Mostafa Gamal Ahmed Mostafa

Helicobacter pylori infection among women with recurrent abortion of unknown cause

Assiut University

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