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Completed

NCT Number: NCT02756143

Exercise During Pregnancy and Perinatal Outcome

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

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Key information

Conditions

Pregnancy Behavior Healthy Motor Activity

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  1. Maternal weight gain during pregnancy

    Time frame: From the beginning of the pregnancy to 1 month postdelivery

Secondary outcomes

  1. Cesarean Section Rate

    Time frame: Birth

  2. Gestational Diabetes

    Time frame: Birth

  3. Preeclampsia

    Time frame: birth

  4. Fetal TAPSE

    Time frame: up to 36 weeks of pregnancy

    Tricuspid Annular Plane Systolic Excursion meassured by echocardiogram

  5. Fetal Tei Index

    Time frame: up to 36 weeks of pregnancy

    Myocardial Performance Index meassured by echocardiogram

  6. Ductus Arteriosus PI

    Time frame: up to 36 weeks

    Ductus Arteriosus Pulsatility Index meassured by echocardiogram

  7. Aortic Isthmus PI

    Time frame: up to 36 weeks

    Aortic Isthmus Pulsatility Index meassured by echocardiogram

  8. Fetal Heart Rate Variability

    Time frame: birth

    Fetal Heart Rate Variability meassured by cardiotocogram

  9. Newborn weight

    Time frame: birth

    birth

  10. Placental weight

    Time frame: birth

Sponsors and collaborators

Lead sponsor

University Hospital of Torrejon

Other

Collaborators

  • Universidad Politecnica de Madrid

Registry information

Official study title

Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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