Comparative clinical study on the effectiveness of Yoni Lepa with Apamarga Vasa gel and dinoprostone gel in first stage of labour
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Spontaneous onset of labour pain with progress and reduced duration of first stage of labour
研究概览
简要总结
This study is a single blind double arm comparative clinical trial to evaluate the possible effect of Apamarga Vasa moola yoni lepa in first stage of labour and to compare its possible effect with Dinoprostone Gel.
This study will be conducted at Inpatient department of Prasuti tantra and Stree roga at Sri Dharmasthala Manjunatheshwara ayurveda hospital, Hassan, Karnataka.
Methods:
During the latent phase of labour- Trial group- 20ml Apamarga Vasa gel will be applied to the posterior fornix at interval of 4 hours.
Control group- dinoprostone gel 0.5mg will be applied to the posterior fornix at interval of 4 hours.
Maximum 3 doses in both groups
Assessment of progress of labour will be done with bishop’s score and partograph in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.subject who fulfill the diagnostic criteria 2.single intrauterine gestation with vertex presentation 3.subject who are agree to participate and ready to sign the consent form.
排除标准
- •1.High risk pregnancy with hypertensive disorders, gestational diabetes mellitus, pulmonary disease, renal disease, psychiatric illness, cardiac disease, epilepsy, severe anemia 2.Diagnosed with HIV, HBsAg, and VDRL 3.Absolutevindication of caesarean section.
结局指标
主要结局
Spontaneous onset of labour pain with progress and reduced duration of first stage of labour
时间窗: Assessment will be done at baseline and once in every 4 hours using bishops score and partograph.
次要结局
- delivery of a live baby(Approximate 12 hours of onset of labour pain.)
研究者
Dr Bharti Yadav
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan