Acute Fetal Response to Prenatal Yoga (TRY)

March 30, 2015 updated by: Dev Maulik, University of Missouri, Kansas City

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Yoga Intervention
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.
Behavioral: Yoga intervention
NO_INTERVENTION: Control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Principal Investigator: Dev Maulik, MD, University of Missouri, Kansas City
  • Study Director: Shilpa Babbar, MD, University of Missouri, Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (ESTIMATE)

February 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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