PregnancyTRYNCT02063711
Acute Fetal Response to Prenatal Yoga
A study testing Yoga intervention in people with Pregnancy, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
Prenatal yoga has become a popular means of exercise during pregnancy. 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?
- Yoga intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- 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
- Uncomplicated singletons pregnancies
- Gestational age between 28 0/7 and 36 6/7 weeks
- No known fetal anomalies
- Women with no prior experience with yoga
- Currently receiving routine prenatal care
- No contraindications to exercise
- Able to read and understand English
- Well dated pregnancy
Who cannot join
- Pregnant minors less than 18 years of age
- Multiple gestations
- Those patients that have been advised by their doctor not to exercise during this pregnancy (i.e. Vaginal bleeding, history of preterm delivery less than 34 weeks, cervical insufficiency, cerclage in place, placenta previa, any chronic medical conditions)
- Congenital fetal anomalies or intrauterine growth restriction
- Cigarette smokers
- Chronic narcotic dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Fetal Response to Prenatal Yoga: A Single Blinded, Randomized Controlled Trial (TRY Yoga Study)
Prenatal yoga has become a popular means of exercise during pregnancy.
Read the detailed description
In 2012, yoga was reported to be practiced by approximately 20 million Americans, out of which 82% are women practitioners. The effects of yoga on the fetus have not been demonstrated. The purpose of this study is to evaluate the acute fetal response to yoga exercises by assessing fetal well-being via ultrasound and non-stress testing among healthy women. The investigators hypothesize that yoga during pregnancy does not have any acute negative effects on fetal behavior as assessed by umbilical artery Dopplers and fetal heart rate or maternal vital signs.
- Conditions
- Pregnancy
- Being tested
- Yoga intervention
- Keywords
- Prenatal Yoga, Yoga, Pregnancy, Yoga, Fetal Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | A 1-hour yoga session will take place with guided instruction provided by a registered yoga instructor. The class includes a warm up period of 5 minutes, which includes sitting with the eyes closed and slowly breathing through the nose. After which the participant will perform a series of yoga postures in coordination with her breathing for approximately 45 minutes. The last 10 minutes of class will encompass a semi-recumbent relaxation period. This is a one time intervention. Receives: Behavioral: Yoga intervention |
| Control group | No intervention | In order to control for 1 hour worth of time, the participants in the control group will be given a 1 hour Power Point presentation on the benefits of exercise and yoga during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
umbilical artery S/D ratio (Dopplers)
The primary outcome of our study will be assessing umbilical artery S/D ratio (Dopplers). Doppler examination will be performed on the day of intervention. Approximately 20-30 minutes prior to the intervention and 20-30 minutes after a 1 hour intervention.
Measured: An umbilical artery ratio will be obtained on the day of intervention via an ultrasound machine. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.
Secondary outcomes (1)
Fetal Heart Rate
The secondary outcome will be the fetal heart rate. To assess if there is a change from 20-30 minutes prior to an intervention, to 20 -30 minutes after a 1 hour intervention.
Measured: Fetal heart rate will be obtained on the day of intervention via a non stress test. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dev Maulik, University of Missouri, Kansas City
- Investigators
- Dev Maulik, MD, Principal investigator, University of Missouri, Kansas CityShilpa Babbar, MD, Study director, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063711
- Sponsor's protocol ID
- 13-941
- Acronym
- TRY
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Babbar S, Porter BW, Williams KB. The Impact of Prenatal Yoga on Exercise Attitudes and Behavior: Teachable moments from a Randomized Controlled Trial. Int J Yoga Therap. 2017 Nov;27(1):37-48. doi: 10.17761/1531-2054-27.1.37.
PubMed 29131740
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Fetal Response to Prenatal Yoga: A Single Blinded, Randomized Controlled Trial (TRY Yoga Study)
- ClinicalTrials.gov ID
- NCT02063711
- Acronym / sponsor ID
- TRY / 13-941
- Conditions
- Pregnancy
- Keywords
- Prenatal Yoga, Yoga, Pregnancy, Yoga, Fetal Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Feb 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.
Prenatal yoga has become a popular means of exercise during pregnancy.
Detailed description
In 2012, yoga was reported to be practiced by approximately 20 million Americans, out of which 82% are women practitioners. The effects of yoga on the fetus have not been demonstrated. The purpose of this study is to evaluate the acute fetal response to yoga exercises by assessing fetal well-being via ultrasound and non-stress testing among healthy women. The investigators hypothesize that yoga during pregnancy does not have any acute negative effects on fetal behavior as assessed by umbilical artery Dopplers and fetal heart rate or maternal vital signs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Behavioral: Yoga interventionA 1-hour yoga session will take place with guided instruction provided by a registered yoga instructor. The class includes a warm up period of 5 minutes, which includes sitting with the eyes closed and slowly breathing through the nose. After which the participant will perform a series of yoga postures in coordination with her breathing for approximately 45 minutes. The last 10 minutes of class will encompass a semi-recumbent relaxation period. This is a one time intervention. |
| Control group | No intervention | –In order to control for 1 hour worth of time, the participants in the control group will be given a 1 hour Power Point presentation on the benefits of exercise and yoga during pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Uncomplicated singletons pregnancies
- Gestational age between 28 0/7 and 36 6/7 weeks
- No known fetal anomalies
- Women with no prior experience with yoga
- Currently receiving routine prenatal care
Key exclusion criteria (6 listed)
- Pregnant minors less than 18 years of age
- Multiple gestations
- Those patients that have been advised by their doctor not to exercise during this pregnancy (i.e. Vaginal bleeding, history of preterm delivery less than 34 weeks, cervical insufficiency, cerclage in place, placenta previa, any chronic medical conditions)
- Congenital fetal anomalies or intrauterine growth restriction
- Cigarette smokers
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 |
|---|---|---|
| Yoga intervention | Behavioural | Yoga Intervention |
Primary outcome
umbilical artery S/D ratio (Dopplers)
Time frame: An umbilical artery ratio will be obtained on the day of intervention via an ultrasound machine. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.
The primary outcome of our study will be assessing umbilical artery S/D ratio (Dopplers). Doppler examination will be performed on the day of intervention. Approximately 20-30 minutes prior to the intervention and 20-30 minutes after a 1 hour intervention.
1 secondary outcome
Fetal Heart Rate
Time frame: Fetal heart rate will be obtained on the day of intervention via a non stress test. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.
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 31 Mar 2015.
- Derived from this study: PubMed 29131740Babbar S, Porter BW, Williams KB. The Impact of Prenatal Yoga on Exercise Attitudes and Behavior: Teachable moments from a Randomized Controlled Trial. Int J Yoga Therap. 2017 Nov;27(1):37-48. doi: 10.17761/1531-2054-27.1.37.
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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.
Dev Maulik, MD principal investigator
University of Missouri, Kansas City
Shilpa Babbar, MD study director
University of Missouri, Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga intervention in people with Pregnancy, run by University of Missouri, Kansas City 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 8 inclusion and 6 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 31 Mar 2015. 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 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?
umbilical artery S/D ratio (Dopplers) (time frame: An umbilical artery ratio will be obtained on the day of intervention via an ultrasound machine. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.). 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 NCT02063711, 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 31 Mar 2015.