Effect of Physical Activity in Pregnancy on Low Grade Inflammation: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 主要终点
- low grade inflammation (in maternal and cord blood)
研究概览
简要总结
This prospective observational study assesses whether women who regularly exercise during pregnancy show reduced low grade Inflammation, compared to women who are not regularly exercising. Furthermore, the effects of regular physical activity in pregnancy on fetal and neonatal outcomes will be investigated. 3 groups of pregnant women will be formed (group 1: regularly physically active women; group 2: physically inactive women and group 3: women with a history of preeclampsia or positive history of metabolic conditions increasing the risk of hypertensive disorders in pregnancy).
详细描述
Pregnancy is a natural state of low grade inflammation in the mother and the feto-placental unit. The severity of this inflammation increases with higher pregravid Body Mass Index (BMI). This is reflected by an increase in pro-inflammatory cytokines in the maternal circulation and in the placenta. It has been proposed that the pro-inflammatory maternal and fetal environment plays a role in mediating pregnancy outcomes.
In non-pregnant individuals regular physical activity is associated with a reduced inflammatory state. The overall objective of the study is to investigate the interaction of maternal physical activity and pregnancy induced low-grade inflammation in the mother and feto-placental unit, and to assess th resulting effects on prenatal and postnatal development.
Specific research objective will be to study effects of maternal physical activity on:
- low grade Inflammation in the mother an feto-placental unit;
- maternal and fetal lipid profiles, including High Density Lipoprotein (HDL) proteome;
- fetal growth and infant body composition;
- transcriptomic and epigenetic profile in the placenta;
- biomarkers of nutritive status;
- psychological assessment: cardiac awareness; assessment of arterial stiffness; stress-coping questionaire
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ongoing pregnancy no later than 14 weeks of gestation
- •giving informed consent
排除标准
- •not wanting to give birth at the University Hospital
- •gestational age > 14 weeks of gestation
- •3 or more consecutive miscarriages
- •increased risk to or above 1:200 after combined test (Minimum parameters: maternal age, fetal crown-rump length (CRL), nuchal translucency, nasal bone and maternal biochemistry)
- •fetal anomalies associated with possible growth or genetic anomalies
- •diagnosed with Diabetes type 1 or 2 (T1D, T2D)
- •for groups 1 and 2: maternal metabolic risk factors (autoimmune conditions, increased risk for thromboembolic events needing anticoagulative therapy)
- •for groups 1 and 2: pre-pregnancy hypertension
结局指标
主要结局
low grade inflammation (in maternal and cord blood)
时间窗: 1 year
clinical inflammation markers: C-reactive protein, cytokines and chemokine (IL1b, IL1a, IL-2, IL-5, IL-6,IL-12, TNFa, MCP-1, MIP1-a) measured by ELISA and multiplexing arrays
次要结局
- maternal and newborn fat distribution(1 year)
- maternal and fetal (cord blood) lipid profiles(1 year)
- neonatal body composition (% body fat)(1 year)
- fetal growth(1 year)
- transcriptome of the placenta(2 years)
- epigenetic analysis of the placenta(2 years)
- biomarkers of nutritional status(2 years)
- psychological assessment(1 year)