“A randomized controlled trial to assess the effectiveness of Yoga and Medical Nutrition Therapy on pregnancy outcomes among women with hypothyroidism at tertiary care setting in Udupi District, Karnatakaâ€.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- maternal fetal and neonatal
研究概览
简要总结
In this study, yoga refers to the selected pranayama, asana and meditation. These will be taught by the yoga therapist from Kasturba hospital Manipal during their antenatal visits from the 16th week of gestation till the 36th week. One session will be held individually per month. If they feel discomfort sitting on the floor, chairs will be provided. Pregnant mothers will have to practice these twice daily till their delivery.
Pranayama includes Anuloma viloma, Suryabhedana, Ujjayee, Bahya Kumbhaka, Bhramari pranayama for 25 minutes and Meditation (Dhyana) includes Soham meditation which is for 10 minutes. Asana for 10 minutes. Preparation and practice is 10 + 45 = 55 minutes. The participants will have to practice these twice a day (morning and evening) and maintain a note regarding the same in the diary book. A diary book will be provided by the investigator at the completion of their first session.
Dietary advice: Pregnant women will be requested to give 24-hour dietary recall for one week (alternate days). Certain vegetables such as legumes, cabbage, cauliflower, broccoli, turnip, forms of root cassava are goitrogens. Soy or soy enriched foods can aggravate thyroid problems reducing T4 absorption and interfering with thyroid hormone action. Dietary advice will be given by the investigator regarding minimizing the consumption of the above-mentioned foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion criteria: Phase I: •Singleton pregnant women who have delivered at the facility and had their booking in first trimester at the facility itself and had TSH estimation as a part of routine investigation will be considered (Those with known thyroid dysfunction also will be included).
- •Phase II: •pregnant women with singleton pregnancy diagnosed with hypothyroidism (at their first antenatal visit during the first trimester) and intending to deliver at the same facility (Those with known thyroid dysfunction also will be included).
排除标准
- •Exclusion criteria: Phase II: •Pregnant women with: -Multiple pregnancies -Overt Diabetes Mellitus -Chronic hypertension -Cardiac disorders -Renal disorder -Hepatic disorders -Epilepsy on treatment -Connective tissue disorders.
结局指标
主要结局
maternal fetal and neonatal
时间窗: monthly outcome evaluation till delivery
次要结局
- The reference level of Thyroid Stimulating Hormone (TSH) during the first trimester among pregnant women.(First trimester)