Physical Activity in Pregnancy

Pregnancy, Physical Activity Clinical Trial

— PAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277807
• Other study ID #: EK 24-245 ex 11/12
• Status: Completed
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 6, 2017
• Start date: February 4, 2013
• Est. completion date: October 11, 2013

Study information

• Verified date: September 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 11, 2013
• Est. primary completion date: October 11, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Physical Activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	maternal and fetal (cord blood) lipid profiles	triglycerides, phospholipids, free fatty acids, HDL/LDL/total cholesterol	1 year
Secondary	neonatal body composition (% body fat)	measured by air displacement plethysmography (Peapod)	1 year
Secondary	maternal and newborn fat distribution	subcutaneous adipose tissue thickness at 15 defined body sites, measured by a lipometer	1 year
Secondary	fetal growth	measured by ultrasound scanner	1 year
Secondary	transcriptome of the placenta	measured by full genome arrays	2 years
Secondary	epigenetic analysis of the placenta	analysed by 450k methylation arrays	2 years
Secondary	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	2 years
Secondary	psychological assessment	assessment of arterial stiffness, stress coping questionnaire, cardiac awareness	1 year