PregnancyNCT03941041
Impact of Prenatal Yoga Practice on Birth Outcome
A study testing Prenatal Yoga Course in people with Pregnancy, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Prenatal Yoga Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Maribor
Maribor, 2000
Lucija Kuder, 0038623211845
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Prenatal Yoga Course
- Keywords
- Yoga, Caesarean Section, Delivery Outcome, Labour Pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Yoga CourseBehavioural
participation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Yoga Practice | Experimental | Pregnant women participating in a yoga course at least 12 session, each session in duration of 90 minutes. Receives: Behavioral: Prenatal Yoga Course |
| Regular Prenatal Care | No intervention | Pregnant women being treated according to national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of caesarean section
yes/no
Measured: Through study completion, an average 1 year
Rate of spontaneous vaginal birth
yes/no
Measured: 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).
Measured: 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
yes/no
Measured: Requests at time of admission to delivery ward
The assesment of anxiety in pregnancy and prior to delivery
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.
Measured: 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)
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.
Measured: 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
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.
Measured: First measurements between 12th and 14th week of pregnancy, second measurement between 36th and 38th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start15 May 2019
- Primary completion30 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucija Kuder, MD, Principal investigator, UMC MariborVesna Elvedi Gasparovic, MD, PhD, Study chair, Clinical Hospital Centre ZagrebFaris Mujezinovic, MD, PhD, Study chair, UMC Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941041
- Sponsor's protocol ID
- IRP-2018-3
- Status last verified
- Nov 2020
- First submitted
- 21 Mar 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babbar S, Shyken J. Yoga in Pregnancy. Clin Obstet Gynecol. 2016 Sep;59(3):600-12. doi: 10.1097/GRF.0000000000000210.
PubMed 27152528Jiang 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.
PubMed 25535930Chuntharapat 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.
PubMed 18396254Babbar 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.
PubMed 26721782Jahdi 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.
PubMed 28438273
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prenatal Yoga Practice on Birth Outcome
- ClinicalTrials.gov ID
- NCT03941041
- Acronym / sponsor ID
- IRP-2018-3
- Conditions
- Pregnancy
- Keywords
- Yoga, Caesarean Section, Delivery Outcome, Labour Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prenatal Yoga Practice | Experimental | Behavioral: Prenatal Yoga CoursePregnant women participating in a yoga course at least 12 session, each session in duration of 90 minutes. |
| Regular Prenatal Care | No intervention | –Pregnant women being treated according to national guidelines |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal Yoga Courseparticipation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week | Behavioural | Prenatal Yoga Practice |
Primary outcome
Rate of caesarean section
Time frame: Through study completion, an average 1 year
yes/no
Rate of spontaneous vaginal birth
Time frame: Through study completion, an average 1 year
yes/no
5 secondary outcomes
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).
Rates of requests for epidural analgesia
Time frame: 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 27152528Babbar S, Shyken J. Yoga in Pregnancy. Clin Obstet Gynecol. 2016 Sep;59(3):600-12. doi: 10.1097/GRF.0000000000000210.
- Background: PubMed 25535930Jiang 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.
- Background: PubMed 18396254Chuntharapat 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.
- Background: PubMed 26721782Babbar 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.
- Background: PubMed 28438273Jahdi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucija Kuder, MD principal investigator
UMC Maribor
Vesna Elvedi Gasparovic, MD, PhD study chair
Clinical Hospital Centre Zagreb
Faris Mujezinovic, MD, PhD study chair
UMC Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Yoga Course in people with Pregnancy, run by University Medical Centre Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucija Kuder, MD (0038623211845, lucija.kuder@ukc-mb.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of caesarean section (time frame: Through study completion, an average 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941041, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.