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临床试验/NCT04314518
NCT04314518招募中不适用

The Correlation Between Immunological Reaction of the Seminal Fluid in the Mother's Blood and Pregnancy Complications

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Pregnancy complications

研究概览

简要总结

It is known that if there isn't an efficient exposure to the paternal antigens before conception, there is an increased risk for the pre-eclampsia (PE) cascade and other pregnancy complications to take place.

It is possible that maternal immune system that doesn't develop tolerance to the paternal antigens that the seminal fluid carries, doesn't developed an adequate immune tolerance to the trophoblast cells and due to that, they are being under greater attack during placentation. Thus, the cells don't go through a normal differentiation, don't perform normal pseudo-vasculogenesis and the PE cascade is more likely to be carried out.

Both the maternal immune system and the paternal alloantigens have a role in the development of PE. Although the specific etiology remains unclear and can be only hypothesized.

In this study the investigators aim is to try and prove that there is a difference in the immunological reactions to semen prior to conception and that these changes are related to PE and/or other obstetric complications.

Hence the investigators aim to study the immune response to semen of women that will be exposed to the culprit semen for the first time compare to women that have been exposed to a culprit semen more than once previously (namely more than 1 insemination prior to the time of evaluation). After that, in a prospective cohort study the investigators would follow those women through their pregnancies and check for different pregnancy outcomes.

In this manner, the investigators are hoping to create a screening tool that will help to predict pregnancy and fetal complications before conception related to maternal immune responses of paternal antigens.

详细描述

The pathophysiology of preeclampsia (PE) likely involves both maternal and fetal/placental factors. It has been established that poor placentation followed by oxidative stress/inflammation and abnormalities in the development of placental vasculature early during pregnancy may result in relative placental ischemia, which then leads to a release of antiangiogenic factors into the maternal circulation. Thus, it changes the maternal systemic endothelial function and cause hypertension and other manifestations of the disease.

Defects in spiral artery remodeling and trophoblast invasion, two related but separate processes, are characteristic of hypertensive disorders of pregnancy and fetal growth restriction. Still, the exact etiology of PE remains elusive.

In normal pregnancies, the cytotrophoblast cells of the developing placenta migrate through the decidua and part of the myometrium to invade both the endothelium and highly muscular tunica media of the maternal spiral arteries. In addition to that, they alter their adhesion molecule expression, a process referred to as pseudo-vasculogenesis.

By comparison, in PE, cytotrophoblasts fail to penetrate the myometrial segment and fail to go through pseudo-vasculogenesis.

Consequently, the spiral arteries fail to develop into large, tortuous vascular channels, resulting in placental hypoperfusion and ischemia. This defect in deep placentation has been associated with development of multiple adverse pregnancy outcomes like PE, fetal death, abruptio placentae, IUGR, Preterm labor etc.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-45
  • 50 women for each group.
  • Primigravid or first insemination from a new partner/sperm donor (group I)
  • Women exposed to sperm (from the same donor/partner ≥ 2 times) (Group II)
  • Singleton gestation
  • Obtained verbal/written consent to participate in study

排除标准

  • o Multiple gestation
  • Multifetal gestation
  • Chronic hypertension
  • Chronic renal disease
  • Autoimmune disease (antiphospholipid syndrome, systemic lupus erythematosus)
  • Vascular disease
  • Pregestational diabetes mellitus

结局指标

主要结局

Pregnancy complications

时间窗: 2 years (Anticipated)

Pregnancy complications including PE, placental abruption, IUGR

次要结局

  • Other pregnancy complications (Clinical or sonographic)(2 years (Anticipated))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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