NCT03941041

Brief Summary

Yoga is a body-mind practice that encompasses a system of postures (asana), stretching exercises combined with breathing (pranayama) and meditation (dharana). About 70% of practitioners are women, the majority of them in their reproductive age. Yoga is on the rise among pregnant women. Prenatal yoga appears to help pregnant women develop mental and physical health and build a connection with their unborn baby. It reduces stress and anxiety, lower back pain, carpal tunnel syndrome symptoms, nausea, headaches and shortness of breath, improves sleep and increase strength, flexibility and endurance of muscles needed for childbirth. A limited number of prospective randomized trials exist about the benefits of yoga in pregnancy and childbirth. An analysis of how yoga exercises in pregnancy affect the labour pattern, the outcome as well as the caesarean rate in a population of European pregnant women will be performed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

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

March 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

March 21, 2019

Last Update Submit

November 3, 2020

Conditions

Pregnancy

Keywords

YogaCaesarean SectionDelivery OutcomeLabour Pain

Outcome Measures

Primary Outcomes (2)

  • Rate of caesarean section

    yes/no

    Through study completion, an average 1 year

  • Rate of spontaneous vaginal birth

    yes/no

    Through study completion, an average 1 year

Secondary Outcomes (5)

  • The level of pain at the 1st stage of labour

    The pain is assessed before pain management in the delivery ward. Assessment through VAS (Visual Analogue Scale:1-10; in wich 1 represent no pain and 10 most severe pain participants had ever experienced).

  • Rates of requests for epidural analgesia

    Requests at time of admission to delivery ward

  • The assesment of anxiety in pregnancy and prior to delivery

    First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week

  • The assessment of childbirth anxiety (W-DEQ - The Wijma Delivery Expectancy/Experience Questionnaire)

    First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week

  • The locally validated locally Pregnancy Concerns Scale (LJZT) Questionnaire of anxiety in pregnancy

    First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week

Study Arms (2)

Prenatal Yoga Practice

EXPERIMENTAL

Pregnant women participating in a yoga course at least 12 session, each session in duration of 90 minutes.

Behavioral: Prenatal Yoga Course

Regular Prenatal Care

NO INTERVENTION

Pregnant women being treated according to national guidelines

Interventions

Prenatal Yoga CourseBEHAVIORAL

participation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week

Prenatal Yoga Practice

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women nulliparous women with singleton pregnancy included in the study during 12-14th week of pregnancy
  • Body Mass Index between 18-30 kg/m2
  • Height above 160 cm
  • normal pelvic measurements (distantia spinarum: 24-26 cm; diastantia cristarum: 26-28 cm; diastantia trochanterica: 28-30 cm)
  • without known anomalies of the fetus
  • regular antenatal check-ups
  • yoga naive

You may not qualify if:

  • multiple pregnancy (twins, triplets ...)
  • contraindications for physical activity in pregnancy (vaginal bleeding, cervical insufficiency, cerclage, placenta praevia)
  • chronic diseases of the pregnant patient (hypertension, diabetes, diseases of the heart of lungs, hematological diseases)
  • anomalies of the reproductive tract
  • previous experience with yoga courses prior to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Maribor

Maribor, 2000, Slovenia

RECRUITING

Related Publications (5)

  • Babbar S, Shyken J. Yoga in Pregnancy. Clin Obstet Gynecol. 2016 Sep;59(3):600-12. doi: 10.1097/GRF.0000000000000210.

    PMID: 27152528BACKGROUND

  • Jiang Q, Wu Z, Zhou L, Dunlop J, Chen P. Effects of yoga intervention during pregnancy: a review for current status. Am J Perinatol. 2015 May;32(6):503-14. doi: 10.1055/s-0034-1396701. Epub 2014 Dec 23.

    PMID: 25535930BACKGROUND

  • Chuntharapat S, Petpichetchian W, Hatthakit U. Yoga during pregnancy: effects on maternal comfort, labor pain and birth outcomes. Complement Ther Clin Pract. 2008 May;14(2):105-15. doi: 10.1016/j.ctcp.2007.12.007. Epub 2008 Mar 4.

    PMID: 18396254BACKGROUND

  • Babbar S, Hill JB, Williams KB, Pinon M, Chauhan SP, Maulik D. Acute feTal behavioral Response to prenatal Yoga: a single, blinded, randomized controlled trial (TRY yoga). Am J Obstet Gynecol. 2016 Mar;214(3):399.e1-8. doi: 10.1016/j.ajog.2015.12.032. Epub 2015 Dec 22.

    PMID: 26721782BACKGROUND

  • Jahdi F, Sheikhan F, Haghani H, Sharifi B, Ghaseminejad A, Khodarahmian M, Rouhana N. Yoga during pregnancy: The effects on labor pain and delivery outcomes (A randomized controlled trial). Complement Ther Clin Pract. 2017 May;27:1-4. doi: 10.1016/j.ctcp.2016.12.002. Epub 2016 Dec 23.

    PMID: 28438273BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lucija Kuder, MD

    UMC Maribor

    PRINCIPAL INVESTIGATOR

  • Vesna Elvedi Gasparovic, MD, PhD

    Clinical Hospital Centre Zagreb

    STUDY CHAIR

  • Faris Mujezinovic, MD, PhD

    UMC Maribor

    STUDY CHAIR

Central Study Contacts

Lucija Kuder, MD

CONTACT

0038623211845lucija.kuder@ukc-mb.si

Monika Sobocan, MD

CONTACT

0038623212178monika.sobocan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2019

First Posted

May 7, 2019

Study Start

May 15, 2019

Primary Completion

May 30, 2023

Study Completion

December 31, 2023

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)