Fetal Cardiovascular Response to Maternal Exercise During Third Trimester

November 13, 2014 updated by: María Perales Santaella, Technical University of Madrid

Effect of a Specific Exercise Program During Whole Pregnancy on Fetal Heart Rate Response to Maternal Effort in Third Trimester. A Randomised Controlled Trial

The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fetal heart rate is considered an important index of fetal well-being, especially during the third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise has remained unclear for several reasons

Most of the studies are focused on obtain data in order to examine the fetal heart rate response to maternal exercise using cardiotocography measurements prior to and following maternal exercise

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Universidad Politécnica de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish
  • Giving birth at Hospital Universitario de Fuenlabrada

Exclusion Criteria:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Behavioral: Exercise group

The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.

Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.
No Intervention: Control
Sedentary pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal heart rate
Time Frame: Up to 34 weeks
Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR
Up to 34 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal outcomes
Time Frame: After labor
Birth weight
After labor
Maternal outcomes
Time Frame: During labor
Type of delivery
During labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fetal responses to exercise

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe