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临床试验/CTRI/2011/10/002096
CTRI/2011/10/002096已完成不适用

The effect of yoga interventions in prevention of pregnancy complications in high risk pregnancies - A randomized controlled obstetric Doppler trial

AYUSH1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2010年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
Maternal Blood Pressure

研究概览

简要总结

Objectives: Previous studies have shown yoga to be effective in improving outcomes in normal pregnancies. This randomized controlled single-blinded trial investigated its effects on the outcomes of high-risk pregnancies. Methods: 68 high-risk pregnant women were randomized into two groups: yoga and control. The yoga group (n=30) received standard care plus one hour of meditative yoga sessions, three times a week, from the 12th to 28th week gestation. The control group (n=38) received only standard care. Fetal measurements and pregnancy complications were assessed. Results: Significantly fewer SGA babies were born in the study group (p=0.033). Both the APGAR1 and APGAR5 scores  were significantly improved in the yoga group (p=0.006). Significantly fewer PIH, preeclampsia, GDM and IUGR cases were observed in the yoga group (p= 0.018, 0.042, 0.049, 0.05 respectively). The reported cases of eclampsia, CPD, PROM, and EMCS, while improved, were not statistically significant (p=0.157, 0.317, 0.919 and 0.617, respectively).  Conclusion:  Yoga is effective in management of some pregnancy complications in high-risk pregnancies and can improve pregnancy outcomes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
14.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •Pregnant women within 8 to 12 weeks of pregnancy and with any of the following risk factors were considered qualified for the study: Bad obstetrics history Twin pregnancies Maternal age between 14 and 20 or between 35 and 45 Obesity (BMI greater than 30) History of pregnancy complications among blood relatives: sister, mother, or grandmother.

排除标准

  • •Qualified subjects with any of the following disorders were excluded from the study: Severe renal, hepatic or gallbladder, or heart disease.
  • •Structural abnormalities in the reproductive system.
  • •Hereditary anemia (such as sickle cell disease) or hemoglobin S-C disease, Seizure disorders.
  • •Taking chemotherapy drugs.
  • •Having sexually transmitted diseases including syphilis and HIV infection.
  • •Having any medical conditions that prevent them from safely and effectively practicing the interventions (e.g. spinal deformities or any DSM-IV type I axis psychiatric condition).

结局指标

主要结局

Maternal Blood Pressure

时间窗: 12th week, 20th week, and 28th week gestation

Protein in urine, Platelet count, blood uric acid, Doppler parameters, stress instruments, and Blood markers: TNF-alpha;, IL-6, IL-10, sFlt-1, E-selectin, endoglin, and adiponectin

时间窗: 12th week, 20th week, and 28th week gestation

次要结局

  • Measure of stress:Objectively: Heart Rate Variability (HRV) and subjectively: Perceived Stress Scale (PSS)(13th week, 20th week, 28th week gestation)

研究者

发起方
AYUSH
申办方类型
Government funding agency

研究点 (1)

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