Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT07293169
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........
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.
Study:
NCT07293169
Study Brief:
Protocol Section:
NCT07293169