Exercise and Pregnancy: Randomized Clinical Trial

Study Overview
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Brief Summary
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The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.

Detailed Description
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The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group. The objectives are: To describe and compare biological and obstetrical variables. To study doppler flow velocimetry indexes. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Official Title
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Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

Conditions
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Preeclampsia, Gestational Diabetes

Intervention / Treatment
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* Other: Physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age < 13 weeks Single pregnancy Alive fetus No previous practice of physical activity Exclusion Criteria: Smoking Chronic maternal diseases Placenta praevia History of preterm labor Bleeding

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: 2<br>Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity) | Other: Physical exercise<br>* Walking 3 times a week during 1 hours (moderate activity)<br>* Other names: physical activity; physical exercise; walking;|
| Experimental: 3<br>Pregnant women starting exercise at 20 weeks | Other: Physical exercise<br>* Walking 3 times a week during 1 hours (moderate activity)<br>* Other names: physical activity; physical exercise; walking;|
| No Intervention: 1<br>Pregnant women without exercise practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit |  | nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries) |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical exercise, maternal complications, preterm labor, birthweight, Apgar scores