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Completed

NCT Number: NCT03277807

Physical Activity in Pregnancy

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).

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Key information

Conditions

Pregnancy, Physical Activity Behavior Motor Activity

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Effect of Physical Activity in Pregnancy on Low Grade Inflammation: a Pilot Study

Acronym: PAP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2017
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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