Exercise and Pregnancy: Randomized Clinical Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Universidade Estadual da Paraiba.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Adriana Suely de Oliveira Melo, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier:
NCT00641550
First received: March 17, 2008
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Preeclampsia
Gestational Diabetes
Other: Physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade Estadual da Paraiba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)
Other: Physical exercise
Walking 3 times a week during 1 hours (moderate activity)
Other Name: physical activity; physical exercise; walking
Experimental: 3
Pregnant women starting exercise at 20 weeks
Other: Physical exercise
Walking 3 times a week during 1 hours (moderate activity)
Other Name: physical activity; physical exercise; walking
No Intervention: 1
Pregnant women without exercise practice.

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.
  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641550

Contacts
Contact: Adriana Melo, MSc 55-83-99732726 asomelo@gmail.com
Contact: Melania Amorim, PhD 55-83-88221514 melamorim@uol.com.br

Locations
Brazil
Universidade Estadual da Paraiba Recruiting
Campina Grande, Paraiba, Brazil, 58100-000
Contact: Adriana Melo, MSc    55-83-99732726    asomelo@gmail.com   
Contact: Melania Amorim, PhD    55-83-88221514    melamorim@uol.com.br   
Principal Investigator: Adriana Melo, MSc         
Universidade Estadual da Paraíba Recruiting
Campina Grande, Paraíba, Brazil, 58100-000
Contact: Adriana Melo, MSc    55-83-99732726    asomelo@gmail.com   
Contact: Melania Amorim, PhD    55-83-88221514    melamorim@uol.com.br   
Principal Investigator: Adriana Melo, MSc         
Sponsors and Collaborators
Universidade Estadual da Paraiba
University of Campinas, Brazil
Investigators
Study Director: Melania Amorim, PhD Instituto Materno Infantil Prof. Fernando Figueira
  More Information

No publications provided by Universidade Estadual da Paraiba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adriana Suely de Oliveira Melo, MD, MSc, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier: NCT00641550     History of Changes
Other Study ID Numbers: EXERC01
Study First Received: March 17, 2008
Last Updated: December 12, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Estadual da Paraiba:
physical exercise
maternal complications
preterm labor
birthweight
Apgar scores

Additional relevant MeSH terms:
Pre-Eclampsia
Diabetes, Gestational
Hypertension, Pregnancy-Induced
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014