Physical Activity in Pregnancy (PAP)
2017年9月6日 更新者：Medical University of Graz
Effect of Physical Activity in Pregnancy on Low Grade Inflammation: a Pilot Study
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).
研究概览
地位
完全的
条件
详细说明
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
研究类型
观察性的
注册 (实际的)
53
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Women with an ongoing healthy pregnancy.
3 groups will be formed: Group1 consists of women performing moderate to vigorous physical activity (PA) before and in early pregnancy.
Group2 consists of women who are not physically active, and Group3 consists of women with a risk of hypertensive disorders or metabolic diseases (not diabetes).
PA before and in early pregnancy will be assessed with a screening questionnaire.
Women reporting a minimum of 150 mins of moderate to vigorous PA per week will be classified as active, women with less PA will be classified as inactive.
20 women each group will be recruited not later than 14 weeks of gestation.
Women will be recruited at the outpatient clinic at the Department of Obstetrics and Gynecology, Medical University of Graz.
描述
Inclusion Criteria:
- ongoing pregnancy no later than 14 weeks of gestation
- giving informed consent
Exclusion Criteria:
- 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
- Smoking
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Active
pregnant women who are physically active (spend a minimum of 150min/week with moderate to vigorous physical activity)
|
|
Inactive
pregnant women who are physically inactive (spend less than 150min/week with moderate to vigorous physical activity)
|
|
risk for hypertensive disorders
pregnant women with a history of preeclampsia or positive history for metabolic conditions increasing the risk of hypertensive disorders in pregnancy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
low grade inflammation (in maternal and cord blood)
大体时间：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
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
maternal and fetal (cord blood) lipid profiles
大体时间：1 year
|
triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol
|
1 year
|
|
neonatal body composition (% body fat)
大体时间：1 year
|
measured by air displacement plethysmography (Peapod)
|
1 year
|
|
maternal and newborn fat distribution
大体时间：1 year
|
subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer
|
1 year
|
|
fetal growth
大体时间：1 year
|
measured by ultrasound scanner
|
1 year
|
|
transcriptome of the placenta
大体时间：2 years
|
measured by full genome arrays
|
2 years
|
|
epigenetic analysis of the placenta
大体时间：2 years
|
analysed by 450k methylation arrays
|
2 years
|
|
biomarkers of nutritional status
大体时间：2 years
|
measurement of blood levels of fatty acids (DHA, EPA, 15:0, 17:0), vitamin A, B1, B2, B6, D2/D3, C, E, homocysteine
|
2 years
|
|
psychological assessment
大体时间：1 year
|
assessment of arterial stiffness, stress coping questionnaire, cardiac awareness
|
1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bence Csapo, MD、Medical University of Graz
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年2月4日
初级完成 (实际的)
2013年10月11日
研究完成 (实际的)
2013年10月11日
研究注册日期
首次提交
2017年8月31日
首先提交符合 QC 标准的
2017年9月6日
首次发布 (实际的)
2017年9月11日
研究记录更新
最后更新发布 (实际的)
2017年9月11日
上次提交的符合 QC 标准的更新
2017年9月6日
最后验证
2017年9月1日
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