Acute Fetal Response to Prenatal Yoga

Pregnancy Clinical Trial

— TRY  

Official title:

Acute Fetal Response to Prenatal Yoga: A Single Blinded, Randomized Controlled Trial (TRY Yoga Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063711
• Other study ID #: 13-941
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: March 30, 2015
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Yoga intervention

Locations

Country	Name	City	State
United States	Truman Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	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.	Yes