PreeclampsiaNCT00641550
Exercise and Pregnancy: Randomized Clinical Trial
A study testing Physical exercise in people with Preeclampsia and Gestational Diabetes, run by Universidade Estadual da Paraiba at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 10 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Gestational Diabetes
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesBrazil
- Study dates
- Apr 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age < 13 weeks
- Single pregnancy
- Alive fetus
- No previous practice of physical activity
Who cannot join
- Smoking
- Chronic maternal diseases
- Placenta praevia
- History of preterm labor
- Bleeding
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Universidade Estadual da Paraiba
Campina Grande, Paraíba, 58100-000
Adriana Melo, MSc, 55-83-99732726, asomelo@gmail.com
Melania Amorim, PhD, 55-83-88221514, melamorim@uol.com.br
- Recruiting
Universidade Estadual da Paraíba
Campina Grande, Paraíba, 58100-000
Adriana Melo, MSc, 55-83-99732726, asomelo@gmail.com
Melania Amorim, PhD, 55-83-88221514, melamorim@uol.com.br
About this study
Official title: Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Preeclampsia, Gestational Diabetes
- Being tested
- Physical exercise
- Keywords
- physical exercise, maternal complications, preterm labor, birthweight, Apgar scores
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational, Motor Activity, Obstetric Labor, Premature, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Also called physical activity; physical exercise; walking
Walking 3 times a week during 1 hours (moderate activity)
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Pregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity) Receives: Other: Physical exercise |
| 3 | Experimental | Pregnant women starting exercise at 20 weeks Receives: Other: Physical exercise |
| 1 | No intervention | Pregnant women without exercise practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit
Measured: nine months
Secondary outcomes (1)
Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual da Paraiba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Principal investigator, Adriana Suely de Oliveira Melo, Universidade Estadual da Paraiba
- Investigators
- Melania Amorim, PhD, Study director, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641550
- Sponsor's protocol ID
- EXERC01
- Status last verified
- Dec 2011
- First submitted
- 17 Mar 2008
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22825089
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00641550
- Acronym / sponsor ID
- EXERC01
- Conditions
- Preeclampsia, Gestational Diabetes
- Keywords
- physical exercise, maternal complications, preterm labor, birthweight, Apgar scores
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Universidade Estadual da ParaibaUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Other: Physical exercisePregnant women starting to practice physical exercise at 13 weeks(Walking moderate activity) |
| 3 | Experimental | Other: Physical exercisePregnant women starting exercise at 20 weeks |
| 1 | No intervention | –Pregnant women without exercise practice. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Gestational age < 13 weeks
- Single pregnancy
- Alive fetus
- No previous practice of physical activity
Key exclusion criteria (5 listed)
- Smoking
- Chronic maternal diseases
- Placenta praevia
- History of preterm labor
- Bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseAlso: physical activity; physical exercise; walkingWalking 3 times a week during 1 hours (moderate activity) | Other | 2, 3 |
Primary outcome
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
1 secondary outcome
Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 22825089de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melania Amorim, PhD study director
Instituto Materno Infantil Prof. Fernando Figueira
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Preeclampsia and Gestational Diabetes, run by Universidade Estadual da Paraiba at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana Melo, MSc (55-83-99732726, asomelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00641550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.