Exercise and Pregnancy: Randomized Clinical Trial - Full Text View

Sponsored by:	Universidade Estadual da Paraiba
Information provided by:	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

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

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:	150
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental Pregnant women starting to practice physical exercise at 13 weeks	Other: Physical exercise Walking 3 times a week during 1 hours (moderate activity)
3: Experimental Pregnant women starting exercise at 20 weeks	Other: Physical exercise Walking 3 times a week during 1 hours (moderate activity)
1: No Intervention Pregnant women without exercise practice.	Other: Physical exercise Walking 3 times a week during 1 hours (moderate activity)

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, Paraíba
Universidade Estadual da Paraíba
Campina Grande, Paraíba, Brazil, 58100-000

Sponsors and Collaborators

Universidade Estadual da Paraiba

Investigators

Study Director:

Melania Amorim, PhD

Instituto Materno Infantil Prof. Fernando Figueira

More Information

Responsible Party:	Universidade Estadual da Paraiba ( Dr. Adriana Melo )
Study ID Numbers:	EXERC01
Study First Received:	March 17, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00641550
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

Study placed in the following topic categories:

Birth Weight
Pregnancy Complications
Metabolic Diseases
Eclampsia
Obstetric Labor, Premature
Diabetes Mellitus
Pre-Eclampsia
Endocrine System Diseases

Diabetes, Gestational
Preeclampsia
Hypertension, Pregnancy-Induced
Pregnancy toxemia /hypertension
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on January 14, 2009