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Clinical Trials/NCT03079258
NCT03079258
Unknown
Not Applicable

Can Physical Activity During Pregnancy Improve Maternal and Offspring Vascular Health?

Liverpool John Moores University1 site in 1 country20 target enrollmentApril 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnant
Sponsor
Liverpool John Moores University
Enrollment
20
Locations
1
Primary Endpoint
Change in Vascular Function
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to determine the effect of aerobic exercise on maternal and offspring vascular health.

Detailed Description

The study will comprise of a randomised pilot trial to assess the effect of a moderate intensity exercise intervention on maternal and offspring vascular health. Participants will be recruited in the first trimester (T1, 10-12 weeks' gestation), and will be randomized to either a 24-week, structured and partially supervised, gym-based exercise intervention beginning in trimester 2 (T2) through to trimester 3 (T3), or a non-exercise control group who receive normal clinical care. The inclusion of this non-exercise control group is critical in allowing us to create an understanding of the adaptation of the vascular system during a normal (non-exercising) pregnancy, and also determining the physical activity and sedentary behaviour engaged in during normal healthy pregnancy. All participants will be asked to attend the laboratory at Liverpool John Moores University on 4 separate occasions synchronised with the end point of each trimester and then within four weeks of delivery. Maternal vascular health, physical activity, sedentary behaviour and fitness will be assessed during each time point throughout pregnancy while the fourth visit will comprise of an offspring vascular assessment. The investigators will also gain information on delivery outcomes including pre-term delivery, complications during labour, induction of labour, caesarean sections and post-partum haemorrhage via medical notes at the Liverpool Women's NHS Foundation Trust.

Registry
clinicaltrials.gov
Start Date
April 23, 2017
End Date
August 3, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Áine Brislane

Principal Investigator Áine Brislane

Liverpool John Moores University

Eligibility Criteria

Inclusion Criteria

  • Healthy pregnant female
  • No history of cardiovascular disease, gestational diabetes or pre-eclampsia
  • Single gestation
  • Not on medication affecting cardiovascular health
  • A non-smoker for at least 6 months
  • Participating in structured exercise \<twice/week
  • BMI \<30kg/m\^2 -

Exclusion Criteria

  • Royal College of Obstetricians and Gynaecologists (RCOG) contraindications for pregnancy
  • Pregnant by in-vitro fertilisation (IVF)exercise
  • BMI \>30kg/m\^2
  • \>45 years old
  • Structured exercise \>twice/week
  • Multiple gestation
  • Disability preventing ambulation
  • Currently smoking or smoking within past 6 months prior to pregnancy
  • Non-English speaking women

Outcomes

Primary Outcomes

Change in Vascular Function

Time Frame: Change from baseline at week 24 and 36 of pregnancy

Vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change.

Secondary Outcomes

  • Change in Physical activity(Change from baseline at week 24 and 36 of pregnancy)
  • Change in Sedentary behaviour(Change from baseline at week 24 and 36 of pregnancy)
  • Incidence of Pregnancy specific outcomes(Following delivery and within 4 weeks)

Study Sites (1)

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