PregnancyNCT02756143
Exercise During Pregnancy and Perinatal Outcome
A study testing Exercise in people with Pregnancy and Healthy, run by University Hospital of Torrejon at 1 site in Spain.
Trial summary
Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Feb 2017
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Able to communicate in spanish
- Giving birth at Torrejon Universitary Hospital
Who cannot join
- Medical or obstetric complication excluding exercise ( ACOG guideline)
- Interested in the study after 18 weeks or pregnancy
- Not availability to attend to the physical exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial
Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.
Read the detailed description
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.
- Being tested
- Exercise
- Keywords
- fetal heart, cesarean section, exercise, pregnancy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Non- supervised physical exercise program during pregnancy |
| Exercise Group | Experimental | Supervised physical exercise program during pregnancy Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight gain during pregnancy
Measured: From the beginning of the pregnancy to 1 month postdelivery
Secondary outcomes (10)
Cesarean Section Rate
Measured: Birth
Gestational Diabetes
Measured: Birth
Preeclampsia
Measured: birth
Fetal TAPSE
Tricuspid Annular Plane Systolic Excursion meassured by echocardiogram
Measured: up to 36 weeks of pregnancy
Fetal Tei Index
Myocardial Performance Index meassured by echocardiogram
Measured: up to 36 weeks of pregnancy
Ductus Arteriosus PI
Ductus Arteriosus Pulsatility Index meassured by echocardiogram
Measured: up to 36 weeks
Aortic Isthmus PI
Aortic Isthmus Pulsatility Index meassured by echocardiogram
Measured: up to 36 weeks
Fetal Heart Rate Variability
Fetal Heart Rate Variability meassured by cardiotocogram
Measured: birth
Newborn weight
birth
Measured: birth
Placental weight
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Torrejon
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Politecnica de Madrid
- Responsible party
- Principal investigator, Maia Brik, University Hospital of Torrejon
- Investigators
- Ruben Barakat, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756143
- Sponsor's protocol ID
- PERINATEXER
- Status last verified
- Oct 2017
- First submitted
- 21 Apr 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02756143
- Acronym / sponsor ID
- PERINATEXER
- Keywords
- fetal heart, cesarean section, exercise, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University Hospital of TorrejonUniversity, hospital or other
- Collaborators
- Universidad Politecnica de Madrid
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Apr 2016 (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.
Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.
Detailed description
The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Non- supervised physical exercise program during pregnancy |
| Exercise Group | Experimental | Behavioral: ExerciseSupervised physical exercise program during pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Able to communicate in spanish
- Giving birth at Torrejon Universitary Hospital
Key exclusion criteria (3 listed)
- Medical or obstetric complication excluding exercise ( ACOG guideline)
- Interested in the study after 18 weeks or pregnancy
- Not availability to attend to the physical exercise program
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 |
|---|---|---|
| ExerciseSupervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate. | Behavioural | Exercise Group |
Primary outcome
Maternal weight gain during pregnancy
Time frame: From the beginning of the pregnancy to 1 month postdelivery
10 secondary outcomes
Cesarean Section Rate
Time frame: Birth
Gestational Diabetes
Time frame: Birth
Preeclampsia
Time frame: birth
Fetal TAPSE
Time frame: up to 36 weeks of pregnancy
Fetal Tei Index
Time frame: up to 36 weeks of pregnancy
Ductus Arteriosus PI
Time frame: up to 36 weeks
Aortic Isthmus PI
Time frame: up to 36 weeks
Fetal Heart Rate Variability
Time frame: birth
Newborn weight
Time frame: birth
Placental weight
Time frame: birth
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 27 Oct 2017.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ruben Barakat principal investigator
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pregnancy and Healthy, run by University Hospital of Torrejon at 1 site in Spain.
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 3 inclusion and 3 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 27 Oct 2017. 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 Spain. 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?
Maternal weight gain during pregnancy (time frame: From the beginning of the pregnancy to 1 month postdelivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2017.