NCT02063711

Brief Summary

Prenatal yoga has become a popular means of exercise during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

January 30, 2014

Last Update Submit

March 30, 2015

Conditions

Pregnancy

Keywords

Prenatal YogaYoga, PregnancyYoga, Fetal Response

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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.

Study Arms (2)

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.

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.

Interventions

Yoga interventionBEHAVIORAL
Yoga Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • 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.

    PMID: 29131740DERIVED

Study Officials

  • Dev Maulik, MD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

  • Shilpa Babbar, MD

    University of Missouri, Kansas City

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

US(1)