Helicobacter Pylori Infection Among Women With Recurrent Abortion of Unknown Cause

NCT07293169 | Not Yet Recruiting DMC

• 1 other identifier: H.pylori infection e abortion
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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........

Conditions

Helicobacter Pylori Infection, Susceptibility to

Outcome Measures

Primary Outcomes (2)

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

  baseline

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

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

  the study will be carried out from October 2025 till October 2026

Study Arms (1)

one group of women with history of recurrent abortion

another group of women without recurrent of abortion

Diagnostic Test: H pylori eradication

Interventions

H pylori eradication DIAGNOSTIC_TEST

h.pylori stool antigen

one group of women with history of recurrent abortion

Eligibility Criteria

• Gender Eligibility Details: * All woman with repeated abortion of Unknwon cause. * Not received H.pylori eradication therapy in prior 3 months .
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• All woman with repeated abortion of Unknwon cause.

You may qualify if:

• Not received H.pylori eradication therapy in prior 3 months .

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Mostafa Gamal Ahmed Mostafa موشا -مركز اسيوط -محافظة اسيوط

CONTACT

01095773806; Moustafa.15235564@med.aun.edu.eg

Hanan Mohamed Nafeh assiut

CONTACT

01003053369; hmnafeh@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helicobacter pylori infection among women with recurrent abortion of unknown cause

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12