Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2019-05-15
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Prenatal Yoga Practice
Pregnant women participating in a yoga course at least 12 session, each session in duration of 90 minutes.
Prenatal Yoga Course
participation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week
Regular Prenatal Care
Pregnant women being treated according to national guidelines
No interventions assigned to this group
Interventions
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Prenatal Yoga Course
participation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
35 Years
FEMALE
Yes
Sponsors
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University Medical Centre Maribor
OTHER
Responsible Party
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Principal Investigators
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Lucija Kuder, MD
Role: PRINCIPAL_INVESTIGATOR
UMC Maribor
Vesna Elvedi Gasparovic, MD, PhD
Role: STUDY_CHAIR
Clinical Hospital Centre Zagreb
Faris Mujezinovic, MD, PhD
Role: STUDY_CHAIR
UMC Maribor
Locations
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University Medical Center Maribor
Maribor, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Lucija Kuder
Role: primary
References
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Babbar S, Shyken J. Yoga in Pregnancy. Clin Obstet Gynecol. 2016 Sep;59(3):600-12. doi: 10.1097/GRF.0000000000000210.
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.
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.
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.
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.
Other Identifiers
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IRP-2018-3
Identifier Type: -
Identifier Source: org_study_id