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Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial (PAMELA)

Primary Purpose

Gestational Hypertension, Prematurity, Maternal Post-partum Depression

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Exercise / Physical Activity
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Hypertension focused on measuring motor activity, clinical trials, pregnancy, hypertension, cohort studies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Hypertension
  • Diabetes
  • Preterm birth history
  • Miscarriage history
  • Heart disease
  • In vitro fertilization
  • Twin pregnancy
  • Persistent bleeding
  • Body mass index above 35kg/m2
  • Heavy smokers (above 20 cigarettes/day)
  • Active women (>150 min/week of physical activity).

Sites / Locations

  • Physical Education School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle intervention

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Prematurity
By the end of the intervention, after birth, the gestational age of each child will be measured to assess the preterm birth rate.

Secondary Outcome Measures

Maternal post-partum depression
A follow-up study will be carried out to assess post-partum maternal depression, comparing intervention and control women.
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.

Full Information

First Posted
May 22, 2014
Last Updated
September 27, 2021
Sponsor
Federal University of Pelotas
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1. Study Identification

Unique Protocol Identification Number
NCT02148965
Brief Title
Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
Acronym
PAMELA
Official Title
Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Hypertension, Prematurity, Maternal Post-partum Depression, Maternal Post-partum Weight Retention, Child's Development
Keywords
motor activity, clinical trials, pregnancy, hypertension, cohort studies

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise / Physical Activity
Intervention Description
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).
Primary Outcome Measure Information:
Title
Prematurity
Description
By the end of the intervention, after birth, the gestational age of each child will be measured to assess the preterm birth rate.
Time Frame
Women will be interviewed at hospital soon after birth (up to 2 days after delivering)
Secondary Outcome Measure Information:
Title
Maternal post-partum depression
Description
A follow-up study will be carried out to assess post-partum maternal depression, comparing intervention and control women.
Time Frame
3 months after the end of intervention
Title
Child's development
Description
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.
Time Frame
Children will be followed-up and evaluated by the ages of 3, 12 and 24 months of age

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Hypertension Diabetes Preterm birth history Miscarriage history Heart disease In vitro fertilization Twin pregnancy Persistent bleeding Body mass index above 35kg/m2 Heavy smokers (above 20 cigarettes/day) Active women (>150 min/week of physical activity).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEDRO C HALLAL, PhD
Organizational Affiliation
Federal University of Pelotas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Education School
City
Pelotas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96055-630
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30646198
Citation
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.
Results Reference
derived
PubMed Identifier
29273044
Citation
da 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.
Results Reference
derived
PubMed Identifier
26003406
Citation
Domingues 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.
Results Reference
derived
Links:
URL
http://www.epidemio-ufpel.org.br
Description
Epidemiology Research Center

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Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial

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