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Physical Activity in Pregnancy (PAP)

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ClinicalTrials.gov Identifier: NCT03277807
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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. 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).

Condition or disease
Pregnancy, Physical Activity

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:

  1. low grade Inflammation in the mother an feto-placental unit;
  2. maternal and fetal lipid profiles, including High Density Lipoprotein (HDL) proteome;
  3. fetal growth and infant body composition;
  4. transcriptomic and epigenetic profile in the placenta;
  5. biomarkers of nutritive status;
  6. psychological assessment: cardiac awareness; assessment of arterial stiffness; stress-coping questionaire

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Physical Activity in Pregnancy on Low Grade Inflammation: a Pilot Study
Actual Study Start Date : February 4, 2013
Actual Primary Completion Date : October 11, 2013
Actual Study Completion Date : October 11, 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. maternal and fetal (cord blood) lipid profiles [ Time Frame: 1 year ]
    triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol

  2. neonatal body composition (% body fat) [ Time Frame: 1 year ]
    measured by air displacement plethysmography (Peapod)

  3. maternal and newborn fat distribution [ Time Frame: 1 year ]
    subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer

  4. fetal growth [ Time Frame: 1 year ]
    measured by ultrasound scanner

  5. transcriptome of the placenta [ Time Frame: 2 years ]
    measured by full genome arrays

  6. epigenetic analysis of the placenta [ Time Frame: 2 years ]
    analysed by 450k methylation arrays

  7. biomarkers of nutritional status [ Time Frame: 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

  8. psychological assessment [ Time Frame: 1 year ]
    assessment of arterial stiffness, stress coping questionnaire, cardiac awareness


Biospecimen Retention:   Samples Without DNA
maternal venous blood (serum /plasma), cord blood (serum /plasma); placenta tissue (RNA later);


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277807


Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Bence Csapo, MD Medical University of Graz

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03277807     History of Changes
Other Study ID Numbers: EK 24-245 ex 11/12
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No