Pregnancy, Physical ActivityPAPNCT03277807
Physical Activity in Pregnancy
An observational study of Pregnancy, Physical Activity, run by Medical University of Graz.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Physical Activity
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2013to 11 Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- ongoing pregnancy no later than 14 weeks of gestation
- giving informed consent
Who cannot join
- 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
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- 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
About this study
Official title: 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).
Read the detailed description
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
- Conditions
- Pregnancy, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (8)
maternal and fetal (cord blood) lipid profiles
triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol
Measured: 1 year
neonatal body composition (% body fat)
measured by air displacement plethysmography (Peapod)
Measured: 1 year
maternal and newborn fat distribution
subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer
Measured: 1 year
fetal growth
measured by ultrasound scanner
Measured: 1 year
transcriptome of the placenta
measured by full genome arrays
Measured: 2 years
epigenetic analysis of the placenta
analysed by 450k methylation arrays
Measured: 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
Measured: 2 years
psychological assessment
assessment of arterial stiffness, stress coping questionnaire, cardiac awareness
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start4 Feb 2013
- Primary completion11 Oct 2013
- Study completion11 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, Physical ActivityStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bence Csapo, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277807
- Sponsor's protocol ID
- EK 24-245 ex 11/12
- Acronym
- PAP
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity in Pregnancy on Low Grade Inflammation: a Pilot Study
- ClinicalTrials.gov ID
- NCT03277807
- Acronym / sponsor ID
- PAP / EK 24-245 ex 11/12
- Conditions
- Pregnancy, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 11 Oct 2013 (actual)
- Study completion
- 11 Oct 2013 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- ongoing pregnancy no later than 14 weeks of gestation
- giving informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
low grade inflammation (in maternal and cord blood)
Time frame: 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
8 secondary outcomes
maternal and fetal (cord blood) lipid profiles
Time frame: 1 year
neonatal body composition (% body fat)
Time frame: 1 year
maternal and newborn fat distribution
Time frame: 1 year
fetal growth
Time frame: 1 year
transcriptome of the placenta
Time frame: 2 years
epigenetic analysis of the placenta
Time frame: 2 years
biomarkers of nutritional status
Time frame: 2 years
psychological assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bence Csapo, MD principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Physical Activity, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low grade inflammation (in maternal and cord blood) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.