Exercise and Pregnancy: Randomized Clinical Trial - Full Text View

Sponsor:	Universidade Estadual da Paraiba
Collaborator:	University of Campinas, Brazil
Information provided by (Responsible Party):	Adriana Suely de Oliveira Melo, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier:	NCT00641550

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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:

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.

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

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

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 February 09, 2012