Helicobacter Pylori Infection Among Women With Recurrent Abortion of Unknown Cause
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: H pylori eradication.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection, Susceptibility to. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
H.Pylori Infection Among Women With Recurrent Abortion of Unknown Cause
Overview
* 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........
Detailed description
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) .
Study duration:
the study will be carried out from October 2025 till October 2026.
Sample size :
the calculated sample size for two groups 100 cases (one group of 50 women with history of recurrent abortion and another group of 50 women without recurrent of abortion).
4.Inclusion criteria
* All woman with repeated abortion of Unknwon cause. * Not received H.pylori eradication therapy in prior 3 months .
5.Exclusion criteria * Known uterine anatomical causes of abortion. * Current systemic antibiotic use and PPIs within 2 weeks. * Medical diseases as (Thyroid disorders , DM,HTN). * Antiphspholipid syndrome. 6.Methods * Case Control study at Assiut woman's heath hospital from October 2025 till October 2026. * Case Control study two groups (one group of women with history of recurrent abortion and another group of women without recurrent of abortion) by stool antigen test.
7.All patients will be subjected to the following * Complete obstetric history , medical history, smoking ,alcohol, recent antibiotics ,PPIs , socioeconomic status * Laboratory samples :
H.pylori antigen in stool ,complete blood count , abdominopelvic ultrasound , urine analysis , liver and kidney function tests ,TSH , prolactin and any necessary investigation will be done.
Anti cardiolipin (IgM , IgG) ,Lupus anti coagulant and Anti B2 glycoproteinA1 (IgM, IgG) and 3D US on uterus . 8.Ethical considerations
* All subjects will provide written informed consent to participate in the study . * The protocol of the study will be presented to the local ethics committee for approval.
9.Statistical analysis * Statistical analysis will be performed using Spss version 23.
10.References * 1\. Malaty HM. Epidemiology of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol 2007; 21: 205-214 * 2\. Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med 2002; 347: 1175-1186 * 3\. Chen MJ, Fang YJ, Wu MS, Chen CC, Chen YN, Yu CC et al. Application of Helicobacter pylori stool antigen test to survey the updated prevalence of Helicobacter pylori infection in Taiwan. 2020;35:233-40 * 4\. Ambühl LM, Baandrup U, Dybkær K,Blaakær J, Uldbjerg N, Sørensen S. Human papillomavirus infection as a possible cause of spontaneous abortion and spontaneous preterm delivery 2016;2016. * 5\. Azami M, Nasirkandy MP, Mansouri A, Darvishi Z, Rahmati S, Abangah G, DehghanHR, Borji M, Abbasalizadeh S. GGollobal Prevelance of H.pylori infection in pregnant women: a systematic review and meta-analysis study. Int J Women's Health Reprod Sci. 2017;5:30-6. * 6\. Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 99:63.
Interventions
- Diagnostic test H pylori eradication
h.pylori stool antigen
Primary outcome measures
- • To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause [Time frame: baseline]
- H.pylori infection among women with recurrent abortion of unknown cause [Time frame: the study will be carried out from October 2025 till October 2026]
Eligibility criteria
Inclusion Criteria• All woman with repeated abortion of Unknwon cause.
- Not received H.pylori eradication therapy in prior 3 months .
Exclusion criteria
- Known uterine anatomical causes of abortion.
- Current systemic antibiotic use and PPIs within 2 weeks.
- Medical diseases as (Thyroid disorders , DM,HTN).
- Antiphspholipid syndrome.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07293169 · H.pylori infection e abortion