Exercise During Pregnancy and Perinatal Outcome

Study Overview
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Brief Summary
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Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.

Detailed Description
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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.

Official Title
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Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial

Conditions
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Pregnancy, Healthy

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Non- supervised physical exercise program during pregnancy | |
| Experimental: Exercise Group<br>Supervised physical exercise program during pregnancy | Behavioral: Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fetal heart, cesarean section, exercise, pregnancy