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Effect of Physical Exercise Program on Fetoplacental Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02420288
Recruitment Status : Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Marina Vargas Terrones, Universidad Politecnica de Madrid

Brief Summary:
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.

Condition or disease Intervention/treatment Phase
Pregnancy Healthy Behavioral: Exercise Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Pregnant women not participating in supervised physical exercise program. The subjects in this group will be monitored during pregnancy to know if they make any kind of exercise on your own, to know which are really sedentary pregnant women.
Experimental: Exercise Group
Pregnant women participating in supervised physical exercise program.
Behavioral: Exercise Group

Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (before week 16 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.

Other Name: Supervised physical exercise program group




Primary Outcome Measures :
  1. Placental weight [ Time Frame: At delivery ]
  2. Fetal birth weight [ Time Frame: At delivery ]
  3. Change from baseline in maternal gestational weight [ Time Frame: 38-42 weeks of gestation ]
    Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy


Secondary Outcome Measures :
  1. Pregestational weight and Body Mass Index (BMI) [ Time Frame: Before pregnancy ]
  2. pH umbilical cord [ Time Frame: At delivery ]
  3. Fetal size outcomes [ Time Frame: At delivery ]
    Size and height, head circumference and body mass index of the baby

  4. Fetal glycemia level [ Time Frame: At delivery ]
  5. Apgar score [ Time Frame: At delivery ]
    Apgar score will be valued 1 and 5 minutes after delivery

  6. Maternal delivery outcomes (composite) [ Time Frame: At delivery ]
    Type of labor, stage and duration of labor

  7. Postpartum depression [ Time Frame: 0-12 postpartum months ]
    The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS)

  8. Changes from baseline in prenatal depression [ Time Frame: Up to 36 weeks ]
    The level of maternal depression during pregnancy will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Center for Epidemiologic Studies Depression Scale (CES-D)

  9. Changes from baseline in maternal quality of life [ Time Frame: Up to 36 weeks ]
    Maternal quality of life will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the Short Form-36 Health Survey (SF-36)

  10. Changes from baseline in urinary incontinence [ Time Frame: Up to 36 weeks ]
    Urinary incontinence will be measured at the beginning and at the end of the pregnancy, as well as at 8 weeks postpartum, with the International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)

  11. Gestational diabetes [ Time Frame: 24-28 weeks ]
    Gestational diabetes will be measured with the O' Sullivan's test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria:

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not having availability to attend to the physical exercise program
  • Younger than 18 years old
  • Older than 45 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420288


Locations
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Spain
Universidad Politécnica de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Politecnica de Madrid
Investigators
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Study Director: Rubén Barakat Carballo, PhD Universidad Politécnica de Madrid
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marina Vargas Terrones, PhD student, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier: NCT02420288    
Other Study ID Numbers: INEF-001
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Keywords provided by Marina Vargas Terrones, Universidad Politecnica de Madrid:
Pregnancy
Fetoplacental growth
Physical exercise
Pregnant
Placental development
Active pregnancy