PregnancyNCT03239054
Prescribing Exercise as Medicine in Pregnancy
A study testing Physical activity in people with Pregnancy, run by St. Louis University at 1 site in United States.
Trial summary
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Dec 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 45 years of age
- Singleton pregnancy
- Gestational age at or less than 20 0/7 weeks at the time of enrollment
- Low risk pregnancy
- Willing and able to participate in a more active lifestyle/exercise program
- Smart phone able to add the "Flow mobile app".
Who cannot join
- Twins or higher order multiple gestations
- Known congenital anomaly
- Underweight BMI ( BMI less than 18.50)
- High risk pregnancy - ie. hypertension, pre-existing diabetes
- Women with a known contraindication to exercise
- Persistent 2nd or 3rd trimester vaginal bleeding
Show all 17Show fewer
- Hemodynamically significant heart disease
- Restrictive lung disease
- Incompetent cervix or cerclage
- Placenta previa
- Premature labor or rupture of membranes
- Preeclampsia
- Severe anemia
- Poorly controlled hypertension, seizure disorder, or hyperthyroidism
- Known intrauterine growth restriction
- Not cleared for exercise by the "Contraindications to Exercise from PARMED-X" form
- PAVS score greater than or equal to 150 minutes/week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
Read the detailed description
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise. Once screened and consented, participants will be randomized to either the intervention or control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription and the control group will receive routine care as usual. Physical activity will be monitored with a Polar fitness tracking device.
Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or absence of gestational diabetes and presence or absence of hypertensive disorders of pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores, arterial cord blood gases.
Psychological outcomes will also be assessed using several validated scales in pregnancy including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety Inventory (STAI).
- Conditions
- Pregnancy
- Being tested
- Physical activity, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
Control groupBehavioural
Information will be given as part of standard care
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise. Receives: Behavioral: Physical activity |
| Control Group | Other | The control group will be provided with the ACOG Pamphlet entitled "Exercise during pregnancy" and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PARmed-X: Change in number of steps (physical activity level)
change in number of steps (physical activity level)
Measured: 1 year
Secondary outcomes (1)
PARMed-X: Gestational Weight Gain
Gestational Weight Gain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jul 2018 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: IRB issues
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
- Model description
- participants will be randomized in a 1:1 fashion into the study group or the control group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shilpa Babbar, MD, St. Louis University
- Investigators
- Shilpa Babbar, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239054
- Sponsor's protocol ID
- 28028
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescribing Exercise as Medicine in Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03239054
- Acronym / sponsor ID
- 28028
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 3 Aug 2017 (actual)
- 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.
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise.
Detailed description
This study is a randomized controlled parallel arms trial. The purpose of this study is to evaluate if prescribing exercise in pregnancy can change maternal behavior towards exercise. Once screened and consented, participants will be randomized to either the intervention or control group in a 1:1 fashion. The intervention group will receive the PARMED-X prescription and the control group will receive routine care as usual. Physical activity will be monitored with a Polar fitness tracking device.
Maternal and neonatal outcomes will be collected from the electronic medical record. Maternal outcomes include demographics, total gestational weight gain, pre-pregnancy body mass index (BMI), BMI at the time of delivery, mode of delivery, glucose screen value, presence or absence of gestational diabetes and presence or absence of hypertensive disorders of pregnancy. Neonatal outcomes include gestational age at delivery, birth weight, Apgar scores, arterial cord blood gases.
Psychological outcomes will also be assessed using several validated scales in pregnancy including The Edinburgh Postnatal Depression Scale (EPDS) and The State Trait Anxiety Inventory (STAI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants will be randomized in a 1:1 fashion into the study group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Physical activityParticipants in the study group will complete the Parmed-X Pregnancy form and be provided with a prescription for exercise. |
| Control Group | Other | Behavioral: Control groupThe control group will be provided with the ACOG Pamphlet entitled "Exercise during pregnancy" and will be encouraged to become physically active during their pregnancy. They will receive routine care as scheduled. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 45 years of age
- Singleton pregnancy
- Gestational age at or less than 20 0/7 weeks at the time of enrollment
- Low risk pregnancy
- Willing and able to participate in a more active lifestyle/exercise program
Key exclusion criteria (17 listed)
- Twins or higher order multiple gestations
- Known congenital anomaly
- Underweight BMI ( BMI less than 18.50)
- High risk pregnancy - ie. hypertension, pre-existing diabetes
- Women with a known contraindication to exercise
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 activitypregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy | Behavioural | Study Group |
| Control groupInformation will be given as part of standard care | Behavioural | Control Group |
Primary outcome
PARmed-X: Change in number of steps (physical activity level)
Time frame: 1 year
change in number of steps (physical activity level)
1 secondary outcome
PARMed-X: Gestational Weight Gain
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- 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.
Shilpa Babbar, MD principal investigator
St. Louis University
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 activity in people with Pregnancy, run by St. Louis University at 1 site in United States.
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 6 inclusion and 17 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: withdrawn, as of the sponsor's last update on 2 Aug 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
PARmed-X: Change in number of steps (physical activity level) (time frame: 1 year). 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 2 Aug 2018.