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Clinical Trials/NCT00641550
NCT00641550
Unknown
Not Applicable

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

Universidade Estadual da Paraiba2 sites in 1 country188 target enrollmentApril 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
Universidade Estadual da Paraiba
Enrollment
188
Locations
2
Primary Endpoint
Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adriana Suely de Oliveira Melo

MD, MSc

Universidade Estadual da Paraiba

Eligibility Criteria

Inclusion Criteria

  • Gestational age \< 13 weeks
  • Single pregnancy
  • Alive fetus
  • No previous practice of physical activity

Exclusion Criteria

  • Chronic maternal diseases
  • Placenta praevia
  • History of preterm labor

Outcomes

Primary Outcomes

Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit

Time Frame: nine months

Secondary Outcomes

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

Study Sites (2)

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