Physical Activity in Pregnancy

NCT ID: NCT03277807

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-04
• Study Completion Date: 2013-10-11

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).

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

Conditions

Pregnancy, Physical Activity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active

pregnant women who are physically active (spend a minimum of 150min/week with moderate to vigorous physical activity)

No interventions assigned to this group

Inactive

pregnant women who are physically inactive (spend less than 150min/week with moderate to vigorous physical activity)

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bence Csapo, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Other Identifiers

EK 24-245 ex 11/12

Identifier Type: -

Identifier Source: org_study_id