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临床试验/NCT03327766
NCT03327766Unknown不适用

Assesment of Vit D3 Level in Cases of Unexplaind Pregnancy Loss in Assiut

Woman's Health University Hospital, Egypt0 个研究点目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
vitamin D level

研究概览

简要总结

Assesment of Vit D3 leve in cases of unexplained recurrent pregnancy loss in assiut

详细描述

Recurrent pregnancy loss is defined as two or more consecutive pregnancy loss before 20 weekse of gestation (1). It affects about 1-5% of women of reproductive age. This not only causes significant physical and mental problems in families, but also a heavy economic burden on families and health systems (2, 3) Recurrent pregnancy loss (RPL) is a syndrome caused by multiple etiologies such as anatomical, endocrine, genetic, infectious, immunological, thrombotic and unexplained etiologies hence an investigation of underlying etiologies is often complicated When the conventional investigation scheme is applied, up to 60% of women with RPL remain unexplained (4). Recent studies have indicated that immune inflammatory and thrombotic conditions are two major under-lying pathologies for RPL (5). Approximately 20% of women with RPL have autoimmune conditions, such as antiphospholipid antibody (APA)(6),antinuclear antibody (ANA), anti-thyroperoxidase antibody and anti-thyroglobulin antibody(7,8).

Immune function in pregnancy From initial implantation of the conceptus, the maternal uterine endometrium undergoes decidualisation to support placental development and function. The resulting decidua is a tissue formed from the maternal endometrium, originating from epithelial and stromal cells, and is characterised by invasion from the extraembryonic fetal-derived trophoblasts and close 'cell-cell juxtaposition' of these different tissues The principal function of the decidua is to facilitate early fetal-maternal exchange of nutrients, gases and waste, while also acting as a secretory source of steroid hormones, cytokines and growth factors (9).However, the decidua also plays a key role in protecting pregnancy against maternal immune surveillance(10) .

Cellular infiltration is a key feature of immune function within decidua, and leukocytes comprise at least 40% of the total decidual stromal cell population(11) . The leukocyte subtypes present include decidual (uterine) natural killer (uNK) cells, macrophage subtypes, CD4C and CD8C T-lymphocytes (including T-regulatory cells (Tregs) and antigen-presenting cells (APCs) such as dendritic cells (DCs)(12) . There has been renewed interest in the role vitamin D, as key regulators of decidual immune cell function and its roles in fetal-maternal immune tolerance (13) .

  • 3 - Vitamin D and autoimmunity Vitamin D, a steroid hormone, is well known to be involved in calcium and phosphate homeostasis and bone metabolism (14).The target organs for the non-classical actions of the vitamin D include immune systems, pancreatic b-cells, the heart and cardiovascular system, the brain and reproductive tissues. Tissue responses to vitamin D include regulation of hormone secretion modulation of immune responses, and a control of cellular proliferation and differentiation (15). Vitamin D was also reported to inhibit proliferation of T helper 1 (Th1) cells and limit their production of cytokines, such as interferon gamma (IFN-g), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-a).Conversely, vitamin D induces T helper 2 (Th2) cytokines, such as IL-4, IL-5, IL-6, IL-9, IL-10 and IL-13 (16). Furthermore, in many studies vitamin D has been presented as a modifiable environmental factor for Th1-mediated autoimmune disease and appears to be important for susceptibility to and severity of the disease (17). Vitamin D also regulates B cell immunity. It down-regulates the proliferation and differentiation of B lymphocytes and inhibits IgG production (16).

Vitamin D deficiency in pregnant women is associated with increased risk of obstetrical complications such as pre-eclampsia (18), bacterial vaginosis associated preterm delivery (19), gestational diabetes mellitus (20) and small-for-gestational age births (21).

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age of women 20:35years old
  • •history of unexplained recurrent pregnancy loss (defined as two or more consecutive missed miscarriage before 14 weeks of gestation).

排除标准

  • •Un corrected uterine anomalies.
  • •Uncontrolled DM .
  • •Systemic disease(SLE,Rheumatoid arthritis).
  • •Thyroid dysfunction.
  • •Antiphospholipid antibody syndrome
  • •Cervical incompetence

结局指标

主要结局

vitamin D level

时间窗: 1 year

the serum level of will be checked in ng/ml

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hisham Ahmed El-Sayed Abou-Taleb

lecturer of obstetrics and gynecology

Woman's Health University Hospital, Egypt

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