Exercise During Pregnancy and Perinatal Outcome

October 26, 2017 updated by: Maia Brik, University Hospital of Torrejon

Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial

Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.

Study Type

Interventional

Enrollment (Actual)

125

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
      • Torrejon de Ardoz, Madrid, Spain, 28850
        • University Hospital de Torrejon

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Able to communicate in spanish
  • Giving birth at Torrejon Universitary Hospital

Exclusion Criteria:

  • Medical or obstetric complication excluding exercise ( ACOG guideline)
  • Interested in the study after 18 weeks or pregnancy
  • Not availability to attend to the physical exercise program

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Non- supervised physical exercise program during pregnancy
Experimental: Exercise Group
Supervised physical exercise program during pregnancy
Behavioral: Exercise

Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.

Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal weight gain during pregnancy
Time Frame: From the beginning of the pregnancy to 1 month postdelivery
From the beginning of the pregnancy to 1 month postdelivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean Section Rate
Time Frame: Birth
Birth
Gestational Diabetes
Time Frame: Birth
Birth
Preeclampsia
Time Frame: birth
birth
Fetal TAPSE
Time Frame: up to 36 weeks of pregnancy
Tricuspid Annular Plane Systolic Excursion meassured by echocardiogram
up to 36 weeks of pregnancy
Fetal Tei Index
Time Frame: up to 36 weeks of pregnancy
Myocardial Performance Index meassured by echocardiogram
up to 36 weeks of pregnancy
Ductus Arteriosus PI
Time Frame: up to 36 weeks
Ductus Arteriosus Pulsatility Index meassured by echocardiogram
up to 36 weeks
Aortic Isthmus PI
Time Frame: up to 36 weeks
Aortic Isthmus Pulsatility Index meassured by echocardiogram
up to 36 weeks
Fetal Heart Rate Variability
Time Frame: birth
Fetal Heart Rate Variability meassured by cardiotocogram
birth
Newborn weight
Time Frame: birth
birth
birth
Placental weight
Time Frame: birth
birth

Collaborators and Investigators

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

Sponsor

University Hospital of Torrejon

Collaborators

Universidad Politecnica de Madrid

Investigators

  • Principal Investigator: Ruben Barakat, Universidad Politecnica de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

November 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PERINATEXER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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