An observational study in Pregnancy, Physical Activity, sponsored by Medical University of Graz. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Medical University of Graz · Observational
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).
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:
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's enrollment of 53 is below the median of 98 across 1,235 observational studies indexed under Motor Activity.
Browse Motor Activity studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pregnant women who are physically active (spend a minimum of 150min/week with moderate to vigorous physical activity)
pregnant women who are physically inactive (spend less than 150min/week with moderate to vigorous physical activity)
pregnant women with a history of preeclampsia or positive history for metabolic conditions increasing the risk of hypertensive disorders in pregnancy
low grade inflammation (in maternal and cord blood)
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
Time frame: 1 year
maternal and fetal (cord blood) lipid profiles
triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol
Time frame: 1 year
neonatal body composition (% body fat)
measured by air displacement plethysmography (Peapod)
Time frame: 1 year
maternal and newborn fat distribution
subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer
Time frame: 1 year
fetal growth
measured by ultrasound scanner
Time frame: 1 year
transcriptome of the placenta
measured by full genome arrays
Time frame: 2 years
epigenetic analysis of the placenta
analysed by 450k methylation arrays
Time frame: 2 years
biomarkers of nutritional status
measurement of blood levels of fatty acids (DHA, EPA, 15:0, 17:0), vitamin A, B1, B2, B6, D2/D3, C, E, homocysteine
Time frame: 2 years
psychological assessment
assessment of arterial stiffness, stress coping questionnaire, cardiac awareness
Time frame: 1 year
No study locations are listed for this record.
Ran from Feb 2013 to primary completion in Oct 2013, 8 months.
Of 490 non-industry observational studies under Motor Activity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 8 months is below that.
Counting every sponsor, half of 500 studies reached it within 22 months; a quarter within 8 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.