Clinical trial NCT02063711: Acute Fetal Response to Prenatal Yoga
Official title: Acute Fetal Response to Prenatal Yoga: A Single Blinded, Randomized Controlled Trial (TRY Yoga Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Prenatal Yoga
Yoga, Pregnancy
Yoga, Fetal Response
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: umbilical artery S/D ratio (Dopplers)
timeFrame: 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:
measure: Fetal Heart Rate
timeFrame: 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.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Dev Maulik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri, Kansas City
name: Shilpa Babbar, MD
role: STUDY_DIRECTOR
References:
citation: 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.