Exercise and Pregnancy: Randomized Clinical Trial
Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial
1 other identifier
interventional
188
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 13, 2011
December 1, 2011
1 year
March 17, 2008
December 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)
9 months
Study Arms (3)
2
EXPERIMENTALPregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)
3
EXPERIMENTALPregnant women starting exercise at 20 weeks
1
NO INTERVENTIONPregnant women without exercise practice.
Interventions
Walking 3 times a week during 1 hours (moderate activity)
Eligibility Criteria
You may qualify if:
- Gestational age \< 13 weeks
- Single pregnancy
- Alive fetus
- No previous practice of physical activity
You may not qualify if:
- Smoking
- Chronic maternal diseases
- Placenta praevia
- History of preterm labor
- Bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Estadual da Paraibalead
- University of Campinas, Brazilcollaborator
Study Sites (2)
Universidade Estadual da Paraiba
Campina Grande, Paraíba, 58100-000, Brazil
Universidade Estadual da Paraíba
Campina Grande, Paraíba, 58100-000, Brazil
Related Publications (1)
de Oliveria Melo AS, Silva JL, Tavares JS, Barros VO, Leite DF, Amorim MM. Effect of a physical exercise program during pregnancy on uteroplacental and fetal blood flow and fetal growth: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):302-10. doi: 10.1097/AOG.0b013e31825de592.
PMID: 22825089DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Melania Amorim, PhD
Instituto Materno Infantil Prof. Fernando Figueira
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
March 17, 2008
First Posted
March 24, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2009
Study Completion
December 1, 2011
Last Updated
December 13, 2011
Record last verified: 2011-12