Effect of Physical Exercise Program on Fetoplacental Growth

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

Official Title
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Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial

Conditions
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Pregnancy, Healthy

Intervention / Treatment
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* Behavioral: Exercise Group


Participation Criteria
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Eligibility Criteria
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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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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<br>Pregnant women participating in supervised physical exercise program. | Behavioral: Exercise Group<br>* 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.<br>* Other names: Supervised physical exercise program group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental weight |  | At delivery | 
| Fetal birth weight |  | At delivery | 
| Change from baseline in maternal gestational weight | Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy | 38-42 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregestational weight and Body Mass Index (BMI) |  | Before pregnancy | 
| pH umbilical cord |  | At delivery | 
| Fetal size outcomes | Size and height, head circumference and body mass index of the baby | At delivery | 
| Fetal glycemia level |  | At delivery | 
| Apgar score | Apgar score will be valued 1 and 5 minutes after delivery | At delivery | 
| Maternal delivery outcomes (composite) | Type of labor, stage and duration of labor | At delivery | 
| Postpartum depression | The level of maternal depression after delivery will be measured with the Edinburgh Postnatal Depression Scale (EPDS) | 0-12 postpartum months | 
| Changes from baseline in prenatal depression | 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) | Up to 36 weeks | 
| Changes from baseline in maternal quality of life | 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) | Up to 36 weeks | 
| Changes from baseline in urinary incontinence | 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) | Up to 36 weeks | 
| Gestational diabetes | Gestational diabetes will be measured with the O' Sullivan's test | 24-28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Fetoplacental growth, Physical exercise, Pregnant, Placental development, Active pregnancy