Impact of Prenatal Yoga Practice on Birth Outcome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Rate of spontaneous vaginal birth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of spontaneous vaginal birth
时间窗: Through study completion, an average 1 year
yes/no
Rate of caesarean section
时间窗: Through study completion, an average 1 year
yes/no
次要结局
- Rates of requests for epidural analgesia(Requests at time of admission to delivery ward)
- 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).)
- 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)