Impact of Prenatal Yoga Practice on Birth Outcome

November 3, 2020 updated by: University Medical Centre Maribor
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed Description:

The study will be a single-blind, prospective, randomised, controlled, clinical trial, with parallel assignment. Investigators intent to analyse labour patterns and outcomes in population of pregnant women which will be divided in a group that will practice yoga and a group that will not. Study will take place at the Department for Perinatology, University Medical Centre Maribor in Slovenia, Central Europe. Both groups will receive standard prenatal care. The intervention group will attend yoga classes 3 times a month. Yoga intervention will be strictly designed, lasting 90 minutes, starting at 12-14 weeks of gestation till delivery. Both groups are intended to give birth at the Department of Perinatology, University Medical Centre Maribor, Slovenia, where we have around 2200 deliveries per year.

Maribor is a university and metropolitan city as well as an educational, cultural, administrative, economic, financial, commercial and tourist centre of the north-eastern part of Slovenia with around 95.000 inhabitants.

Recruitment process Participants will be informed about the study at their gynaecologist at primary health care level in Maribor, Slovenia. Primary level gynaecologists will direct participants. Women at 12-14th week of gestation will approach the research stuff at the reception of Department of Perinatology, University Medical Centre Maribor. Participants will be introduced to the project Yoga in pregnancy. Then they will be escorted by the staff to a private room, where the study will be explained in details. Participants will be screened using written protocol. Qualified pregnant women will have the opportunity to sign a informed consent. When the informed consent is signed, the recruitment process will be completed.

Randomization Investigators will use simple randomisation of pregnant women in two groups: yoga and control. The selection (yoga or control) will be printed and placed in opaque envelopes, which will be kept and locked in a cabinet. Recruited pregnant women will be given an ID code and permit to pick one of the available envelopes to determine the group selection.

Blinding The outcome assessors will be blind for group selection: the physicians, midwifes, nurses and hospital staff.

Intervention The yoga group will receive standard care, plus yoga intervention on average 3 times a month lasting 90 minutes, beginning at 12 -14th week of gestation to the end of pregnancy. The goal is that a woman completes 12 sessions. The control group will receive standard prenatal care. The yoga practice will be conducted according to yoga system of the author Swami Maheshwarananda, named "Yoga in Daily Life" by well - trained, certified yoga teacher. Standard care for both groups include regular check-ups by the gynaecologists.

Four categories of yoga intervention will be offered to the study group:

deep relaxation practice, yogic postures, breathing exercises, meditation and visualisation exercises. Longer relaxation: 7-10 minutes, lying postures on the left side of the body is performed in the beginning of the practice. Two shorter relaxation exercises lasting 2-3 minutes are performed between yogic postures and at the beginning of the meditation and visualisation. Yoga postures will strengthen the body core and pelvic floor muscles. Meditative exercises include visualization, guided imagery and sound resonance techniques that supports the emotional bonding with the unborn baby. Participants will be asked to visualize the fetus in the uterus, the umbilical cord and the placenta. Then they will be guided to imagine the blood flow from their bodies into the placenta, through the umbilical cord, and bring nourishment, accompanied by positive emotions to their fetuses.

Study Type

Interventional

Enrollment (Anticipated)

210

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 Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Maribor, Slovenia, 2000
        • Recruiting
        • University medical center Maribor
        • Contact:
          • Lucija Kuder
          • Phone Number: 0038623211845

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prenatal Yoga Practice
Pregnant women participating in a yoga course at least 12 session, each session in duration of 90 minutes.
Behavioral: Prenatal Yoga Course
participation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week
No Intervention: Regular Prenatal Care
Pregnant women being treated according to national guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of caesarean section
Time Frame: Through study completion, an average 1 year
yes/no
Through study completion, an average 1 year
Rate of spontaneous vaginal birth
Time Frame: Through study completion, an average 1 year
yes/no
Through study completion, an average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of pain at the 1st stage of labour
Time Frame: 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).
The pain is assessed before pain management in the delivery ward. Assessment through VAS (Visual Analogue Scale).
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
Time Frame: Requests at time of admission to delivery ward
yes/no
Requests at time of admission to delivery ward
The assesment of anxiety in pregnancy and prior to delivery
Time Frame: First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week
Using the STAI - State-Trait Anxiety Inventory. The study will use both, STAI-X1 and STAI-X2. STAI-X1 assesses current states of anxiety and STAI-X2 assesses anxiety as a personality trait. The Likert scale consist of 4 possible answers for statements assessing anxiety (ranging from never to very). According to the answers a key for evaluation is provided.
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)
Time Frame: First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week
W-DEQ A questionnaire have 33 items. Woman is instructed to rate her personal feelings and cognitions on a six-point Likert scale with the endpoints market with "not at all" and "extremely" (0-5). The minimum score is 0, and the maximum score 165. The higher the score, the greater the fear of childbirth manifested.
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
Time Frame: First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week
PCS have 16 items. Participant rate her personal feelings on a four-point scale with endpoints "not concerned" and "pronounced concerned" (0-3). The minimum score is 0, and the maximum score 48.
First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week

Collaborators and Investigators

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

Sponsor

University Medical Centre Maribor

Investigators

  • Principal Investigator: Lucija Kuder, MD, UMC Maribor
  • Study Chair: Vesna Elvedi Gasparovic, MD, PhD, Clinical Hospital Centre Zagreb
  • Study Chair: Faris Mujezinovic, MD, PhD, UMC Maribor

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 (Actual)

May 15, 2019

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRP-2018-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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