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Exercise and Pregnancy: Randomized Clinical Trial

Primary Purpose

Preeclampsia, Gestational Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
Universidade Estadual da Paraiba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring physical exercise, maternal complications, preterm labor, birthweight, Apgar scores

Eligibility Criteria

10 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Estadual da ParaibaRecruiting
  • Universidade Estadual da ParaíbaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

2

3

1

Arm Description

Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)

Pregnant women starting exercise at 20 weeks

Pregnant women without exercise practice.

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2008
Last Updated
December 12, 2011
Sponsor
Universidade Estadual da Paraiba
Collaborators
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT00641550
Brief Title
Exercise and Pregnancy: Randomized Clinical Trial
Official Title
Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual da Paraiba
Collaborators
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Gestational Diabetes
Keywords
physical exercise, maternal complications, preterm labor, birthweight, Apgar scores

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity)
Arm Title
3
Arm Type
Experimental
Arm Description
Pregnant women starting exercise at 20 weeks
Arm Title
1
Arm Type
No Intervention
Arm Description
Pregnant women without exercise practice.
Intervention Type
Other
Intervention Name(s)
Physical exercise
Other Intervention Name(s)
physical activity; physical exercise; walking
Intervention Description
Walking 3 times a week during 1 hours (moderate activity)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Melo, MSc
Phone
55-83-99732726
Email
asomelo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melania Amorim, PhD
Phone
55-83-88221514
Email
melamorim@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melania Amorim, PhD
Organizational Affiliation
Instituto Materno Infantil Prof. Fernando Figueira
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Estadual da Paraiba
City
Campina Grande
State/Province
Paraiba
ZIP/Postal Code
58100-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Melo, MSc
Phone
55-83-99732726
Email
asomelo@gmail.com
First Name & Middle Initial & Last Name & Degree
Melania Amorim, PhD
Phone
55-83-88221514
Email
melamorim@uol.com.br
First Name & Middle Initial & Last Name & Degree
Adriana Melo, MSc
Facility Name
Universidade Estadual da Paraíba
City
Campina Grande
State/Province
Paraíba
ZIP/Postal Code
58100-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Melo, MSc
Phone
55-83-99732726
Email
asomelo@gmail.com
First Name & Middle Initial & Last Name & Degree
Melania Amorim, PhD
Phone
55-83-88221514
Email
melamorim@uol.com.br
First Name & Middle Initial & Last Name & Degree
Adriana Melo, MSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
22825089
Citation
de Oliveria Melo AS, Silva JL, Tavares JS, Barros VO, Leite DF, Amorim MM. Effect of a physical exercise program during pregnancy on uteroplacental and fetal blood flow and fetal growth: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):302-10. doi: 10.1097/AOG.0b013e31825de592.
Results Reference
derived

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Exercise and Pregnancy: Randomized Clinical Trial

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