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临床试验/NCT06281262
NCT06281262招募中不适用

The Role of Selected Immunological Indicators and Microbiota in Patients Experiencing Premature Birth and Preeclampsia

General University Hospital, Prague1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia

研究概览

简要总结

The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota.

详细描述

OBJECTIVES

The primary objective of this project is to determine the differences between the circulating pool of regulatory Treg subpopulation proportions and the placental populations in patients with preterm birth and preeclampsia. Pilot study was conducted for the primary objective. Another objective is to evaluate the effect of microbiota on the regulation of Treg cells, especially in relation to mechanisms of preterm birth and preeclampsia. With growing knowledge of the role of microbiota, it is considered that the maternal microbiota could significantly influence setting of immunoregulatory responses even prenatally. Since Treg play a key role in regulating the immunological balance and are indispensable for induction and maintenance of peripheral tolerance, the investigators hypothesise that abnormalities in function of this population are important factors in increasing the risk of gestational pathologies (preterm birth and preeclampsia). Such dysregulation is most likely accompanied by disruption of the physiological Treg epigenetic profile which is in turn influenced by aberrant microbiota composition. Better understanding of these processes and identification of positively or negatively participating bacterial species could enable more reliable prediction of risk-pregnancy and allow for modulation of microbiota to be applied preventively.

Premature birth is defined as pregnancy termination before the end of the gestational week 37. It plays a role in 10% of all pregnancies including spontaneous or medically induced labours. The efforts to postpone premature labour are continuously developed to minimise the consequences such as low birth weight and other risk events. Preeclampsia is a serious blood pressure condition that develops during pregnancy. People with preeclampsia often have high blood pressure (hypertension) and high levels of protein in their urine (proteinuria). It plays role in 5% of all pregnancies. Preeclampsia typically develops after the 20th week of pregnancy. It can also affect other organs in the body and be dangerous for both the mother and her unborn child. Therefore, a great number of scientific studies are now focused on the early prediction of premature labour and preeclampsia and on finding a specific parameter to estimate female patients at premature labour and preeclampsia risk.

HYPOTHESIS AND AIMS

Hypothesis 1: Disbalance between tolerogenic T cell subsets (Treg, Th2, Th9 and Th22) and proinflammatory subsets (Th1 and Th17) is a sign of premature birth or preeclampsia.

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
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singletone pregnancy
  • gestational age 9+0 - 12+0
  • history of preeclampsia (PE)
  • history of spontaneous preterm birth (PTL = preterm labour)
  • history of pPROM (preterm premature rupture of membranes).

排除标准

  • uterine malformations
  • gestational age out of 9+0 - 12+0
  • age out of 19-40

结局指标

主要结局

Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia

时间窗: 3 years

The phenotypic characteristics of leukocytes will be compared between the two groups of pregnant women to identify immunological markers of pre-eclampsia. Peripheral blood from age-matched healthy nonpregnant women (N=20) will also be collected to define a baseline for the measured leukocyte populations. Furthermore, the composition of placenta infiltrating lymphocytes will be compared between groups and following delivery.

Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth

时间窗: 3 years

The phenotypic characteristics of leukocytes will be compared between the two groups of pregnant women to identify immunological markers of preterm delivery. Peripheral blood from age-matched healthy nonpregnant women (N=20) will also be collected to define a baseline for the measured leukocyte populations. Furthermore, the composition of placenta infiltrating lymphocytes will be compared between groups and following delivery.

次要结局

  • Association of maternal microbiota and maternal T regulatory cell populations.(3 years)

研究者

发起方
General University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zdenek Lastuvka

Principal investigator, MD

General University Hospital, Prague

研究点 (1)

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