Exercise and Pregnancy: Randomized Clinical Trial

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00641550
• Other study ID #: EXERC01
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2008
• Last updated: December 12, 2011
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Universidade Estadual da Paraiba
• Contact: Adriana Melo, MSc
• Phone: 55-83-99732726
• Email: asomelo[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Preeclampsia

Intervention

Other:
• Physical exercise
Walking 3 times a week during 1 hours (moderate activity)

Locations

Country	Name	City	State
Brazil	Universidade Estadual da Paraiba	Campina Grande	Paraiba
Brazil	Universidade Estadual da Paraíba	Campina Grande	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual da Paraiba	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit		nine months	Yes
Secondary	Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)		9 months	No