Gestational HypertensionPAMELANCT02148965
Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
A study testing Physical Exercise / Physical Activity in people with Gestational Hypertension and Prematurity, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension, Prematurity, Maternal Post-partum Depression
- What is being tested?
- Physical Exercise / Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Sep 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women who are at least in their 20th week of gestation, living in the city of Pelotas (Brazil), whose deliveries are due to 2015 and belonging to the 2015 Birth Cohort.
Who cannot join
- Hypertension
- Diabetes
- Preterm birth history
- Miscarriage history
- Heart disease
- In vitro fertilization
Show all 11Show fewer
- Twin pregnancy
- Persistent bleeding
- Body mass index above 35kg/m2
- Heavy smokers (above 20 cigarettes/day)
- Active women (>150 min/week of physical activity).
Trial locations and contacts
1 site in 1 country.
About this study
The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.
Read the detailed description
Introduction World Health Organization estimates that nearly 10% of births are preterm worldwide. In the city of Pelotas, based on previous population studies, the preterm birth rate is increasing (6.3% to 14.7% from 1982 to 2004). Preterm birth (PB) is a major public health issue as it is associated to most cases of neonatal deaths and its consequences are linked to later health outcomes.
One of the strongest predictors of PB is gestational hypertension (or eclampsia). PB risk and gestational hypertension may be altered by maternal behavior, such as leisure-time physical activity (LTPA), and overall maternal health influences the likelihood of both outcomes occurring. Biological plausibility lies on the fact that hypertension conditions are potentially influenced by LTPA directly or indirectly (as in the relation between excessive gestational weight gain and physical activity). Also, there is evidence that mental health plays a role in the determination of PB and, although biased by cross-sectional nature of studies, literature shows that physical activity may influence positively psychological aspects during pregnancy.
In Brazil less than 20% of pregnant women are physically active during leisure. Physical activity during pregnancy is associated to several characteristics resulting in improved health profiles that could potentially decrease hypertension occurrence and consequently preterm birth rates. However, few clinical trials have been carried out to study such relationship in representative population samples and many of the available evidence are based solely on observational studies.
Although early studies on the effects of leisure-time physical activity during pregnancy were concerned about potential harmful effects to the health of the mother and the fetus, these have not been proven over time. Currently, there is growing evidence supporting the safe promotion of physical activity during pregnancy targeting benefits to maternal and child health. However, most of the scientific evidence derives from observational studies. There is an urgent need for results from well-designed experimental studies that enable a better understanding of the impact of exercise during pregnancy on various health outcomes maternal and child.
Methodology The intervention will start after the 12th and before the 20th week of gestation and will last until the end of pregnancy or when women feel uncomfortable with the exercise routine. The intervention will consist of three weekly exercise sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence). Workouts will be guided and supervised by physical education professionals previously trained. The intensity of the exercises will be set according to woman's fitness level and will be altered according to the progress of pregnancy based on the perceived effort. All exercise sessions will take place at the School of Physical Education from the Federal University of Pelotas.
- Conditions
- Gestational Hypertension, Prematurity, Maternal Post-partum Depression, Maternal Post-partum Weight Retention, Child's Development
- Being tested
- Physical Exercise / Physical Activity
- Keywords
- motor activity, clinical trials, pregnancy, hypertension, cohort studies
- Medical subject headings
- Hypertension, Pregnancy-Induced, Premature Birth, Motor Activity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise / Physical ActivityBehavioural
Lifestyle intervention Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence).
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Physical Exercise / Physical Activity. Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence). Receives: Behavioral: Physical Exercise / Physical Activity |
| Control Group | No intervention | A group of eligible women, twice as large as the intervention group, will not receive the exercise intervention but will be followed-up equally to compare outcomes in the future. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prematurity
By the end of the intervention, after birth, the gestational age of each child will be measured to assess the preterm birth rate.
Measured: Women will be interviewed at hospital soon after birth (up to 2 days after delivering)
Secondary outcomes (2)
Maternal post-partum depression
A follow-up study will be carried out to assess post-partum maternal depression, comparing intervention and control women.
Measured: 3 months after the end of intervention
Child's development
During the follow-up visits that will take place in the early years of childhood, children from mothers enrolled in the intervention/control groups will be compared with neurodevelopment screening tools.
Measured: Children will be followed-up and evaluated by the ages of 3, 12 and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies 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
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARLOS RODRIGUES DOMINGUES, Federal University of Pelotas
- Investigators
- PEDRO C HALLAL, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148965
- Sponsor's protocol ID
- PAMELA-649.244
- Other IDs
- Wellcome Trust - 522.064
- Acronym
- PAMELA
- Status last verified
- Sep 2021
- First submitted
- 22 May 2014
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Coll CVN, Domingues MR, Stein A, da Silva BGC, Bassani DG, Hartwig FP, da Silva ICM, da Silveira MF, da Silva SG, Bertoldi AD. Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186861. doi: 10.1001/jamanetworkopen.2018.6861.
PubMed 30646198da Silva SG, Hallal PC, Domingues MR, Bertoldi AD, Silveira MFD, Bassani D, da Silva ICM, da Silva BGC, Coll CVN, Evenson K. A randomized controlled trial of exercise during pregnancy on maternal and neonatal outcomes: results from the PAMELA study. Int J Behav Nutr Phys Act. 2017 Dec 22;14(1):175. doi: 10.1186/s12966-017-0632-6.
PubMed 29273044Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.
PubMed 26003406
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02148965
- Acronym / sponsor ID
- PAMELA / PAMELA-649.244
- Conditions
- Gestational Hypertension, Prematurity, Maternal Post-partum Depression, Maternal Post-partum Weight Retention, Child's Development
- Keywords
- motor activity, clinical trials, pregnancy, hypertension, cohort studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 May 2014 (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 Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.
Detailed description
Introduction World Health Organization estimates that nearly 10% of births are preterm worldwide. In the city of Pelotas, based on previous population studies, the preterm birth rate is increasing (6.3% to 14.7% from 1982 to 2004). Preterm birth (PB) is a major public health issue as it is associated to most cases of neonatal deaths and its consequences are linked to later health outcomes.
One of the strongest predictors of PB is gestational hypertension (or eclampsia). PB risk and gestational hypertension may be altered by maternal behavior, such as leisure-time physical activity (LTPA), and overall maternal health influences the likelihood of both outcomes occurring. Biological plausibility lies on the fact that hypertension conditions are potentially influenced by LTPA directly or indirectly (as in the relation between excessive gestational weight gain and physical activity). Also, there is evidence that mental health plays a role in the determination of PB and, although biased by cross-sectional nature of studies, literature shows that physical activity may influence positively psychological aspects during pregnancy.
In Brazil less than 20% of pregnant women are physically active during leisure. Physical activity during pregnancy is associated to several characteristics resulting in improved health profiles that could potentially decrease hypertension occurrence and consequently preterm birth rates. However, few clinical trials have been carried out to study such relationship in representative population samples and many of the available evidence are based solely on observational studies.
Although early studies on the effects of leisure-time physical activity during pregnancy were concerned about potential harmful effects to the health of the mother and the fetus, these have not been proven over time. Currently, there is growing evidence supporting the safe promotion of physical activity during pregnancy targeting benefits to maternal and child health. However, most of the scientific evidence derives from observational studies. There is an urgent need for results from well-designed experimental studies that enable a better understanding of the impact of exercise during pregnancy on various health outcomes maternal and child.
Methodology The intervention will start after the 12th and before the 20th week of gestation and will last until the end of pregnancy or when women feel uncomfortable with the exercise routine. The intervention will consist of three weekly exercise sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence). Workouts will be guided and supervised by physical education professionals previously trained. The intensity of the exercises will be set according to woman's fitness level and will be altered according to the progress of pregnancy based on the perceived effort. All exercise sessions will take place at the School of Physical Education from the Federal University of Pelotas.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Physical Exercise / Physical ActivityPhysical Exercise / Physical Activity. Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence). |
| Control Group | No intervention | –A group of eligible women, twice as large as the intervention group, will not receive the exercise intervention but will be followed-up equally to compare outcomes in the future. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women who are at least in their 20th week of gestation, living in the city of Pelotas (Brazil), whose deliveries are due to 2015 and belonging to the 2015 Birth Cohort.
Key exclusion criteria (11 listed)
- Hypertension
- Diabetes
- Preterm birth history
- Miscarriage history
- Heart disease
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 Exercise / Physical ActivityLifestyle intervention Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence). | Behavioural | Lifestyle intervention |
Primary outcome
Prematurity
Time frame: Women will be interviewed at hospital soon after birth (up to 2 days after delivering)
By the end of the intervention, after birth, the gestational age of each child will be measured to assess the preterm birth rate.
2 secondary outcomes
Maternal post-partum depression
Time frame: 3 months after the end of intervention
Child's development
Time frame: Children will be followed-up and evaluated by the ages of 3, 12 and 24 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 30646198Coll CVN, Domingues MR, Stein A, da Silva BGC, Bassani DG, Hartwig FP, da Silva ICM, da Silveira MF, da Silva SG, Bertoldi AD. Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186861. doi: 10.1001/jamanetworkopen.2018.6861.
- Derived from this study: PubMed 29273044da Silva SG, Hallal PC, Domingues MR, Bertoldi AD, Silveira MFD, Bassani D, da Silva ICM, da Silva BGC, Coll CVN, Evenson K. A randomized controlled trial of exercise during pregnancy on maternal and neonatal outcomes: results from the PAMELA study. Int J Behav Nutr Phys Act. 2017 Dec 22;14(1):175. doi: 10.1186/s12966-017-0632-6.
- Derived from this study: PubMed 26003406Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.
- Epidemiology Research CenterLink provided by the sponsor.
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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.
PEDRO C HALLAL, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise / Physical Activity in people with Gestational Hypertension and Prematurity, run by Federal University of Pelotas at 1 site 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prematurity (time frame: Women will be interviewed at hospital soon after birth (up to 2 days after delivering)). 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 NCT02148965, which also lists 3 linked publications.
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 29 Sep 2021.