Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pregnancy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Care Provider, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 20 years and 35 years
Gender
Only males

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 tha...

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.

Tracking Information

NCT #
NCT03941041
Collaborators
Not Provided
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