Exercise and Pregnancy: Randomized Clinical Trial

NCT ID: NCT00641550

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Preeclampsia Gestational Diabetes

Keywords

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physical exercise maternal complications preterm labor birthweight Apgar scores

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2

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

Group Type EXPERIMENTAL

Physical exercise

Intervention Type OTHER

Walking 3 times a week during 1 hours (moderate activity)

3

Pregnant women starting exercise at 20 weeks

Group Type EXPERIMENTAL

Physical exercise

Intervention Type OTHER

Walking 3 times a week during 1 hours (moderate activity)

1

Pregnant women without exercise practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical exercise

Walking 3 times a week during 1 hours (moderate activity)

Intervention Type OTHER

Other Intervention Names

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physical activity; physical exercise; walking

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role collaborator

Universidade Estadual da Paraiba

OTHER

Sponsor Role lead

Responsible Party

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Adriana Suely de Oliveira Melo

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melania Amorim, PhD

Role: STUDY_DIRECTOR

Instituto Materno Infantil Prof. Fernando Figueira

Locations

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Universidade Estadual da Paraiba

Campina Grande, Paraíba, Brazil

Site Status RECRUITING

Universidade Estadual da Paraíba

Campina Grande, Paraíba, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Adriana Melo, MSc

Role: CONTACT

Phone: 55-83-99732726

Email: [email protected]

Melania Amorim, PhD

Role: CONTACT

Phone: 55-83-88221514

Email: [email protected]

Facility Contacts

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Adriana Melo, MSc

Role: primary

Melania Amorim, PhD

Role: backup

Adriana Melo, MSc

Role: primary

Melania Amorim, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 22825089 (View on PubMed)

Other Identifiers

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EXERC01

Identifier Type: -

Identifier Source: org_study_id