Exercise and Pregnancy: Randomized Clinical Trial

Not Applicable

• Conditions: Preeclampsia; Gestational Diabetes
• Interventions: Other: Physical exercise

• Registration Number: NCT00641550
• Lead Sponsor: Universidade Estadual da Paraiba

Brief Summary

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

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:

1. To describe and compare biological and obstetrical variables.

2. To study doppler flow velocimetry indexes.

3. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.

4. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

Study Timeline

• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-24
• Study Start: 2008-04
• Primary Completion: 2009-04
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Physical exercise	Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)
3	Physical exercise	Pregnant women starting exercise at 20 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)	9 months

Trial Locations

Locations (2)

Universidade Estadual da Paraíba; 🇧🇷 Campina Grande, Paraíba, Brazil

Universidade Estadual da Paraiba; 🇧🇷 Campina Grande, Paraiba, Brazil