A Randomized comparative clinical trial to evaluate the efficacy of Integrated and Ayurvedic protocol in achieving Sukhaprasava.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sukhaprasava (Normal Vaginal Delivery)
研究概览
简要总结
Need of Study:
To decrease the utilization of oxytocic drugs in conduction of normal vaginal delivery.
Protracted cervical dilatation and unripe cervix are the leading causes of fetal distress and prolonged labor. Yoni Pichu application during 9th month brings optimum effacement and ripening of cervix as it causes hydration of tissues and remodeling of cervix.
Basti and Yoni Pichu increases uterine tone and avoid atonic PPH and reduce the rate of obstetric hysterectomy due to PPH.
Null Hypothesis: There is no difference between Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Alternate hypothesis: There is difference between Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Research Question: Is there any difference between Integrated and Ayurvedic protocol in achieving Sukhaprasava?
Aim: To evaluate and compare the efficacy of Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Primary Objective: To evaluate and compare the efficacy of Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Secondary Objective:
To access and compare the incidence of complications of all the four stages of labor and up to 10 days after delivery.
To access and compare the rate of Sukhaprasava (Eutocia) and Shalyajanana (Caesarean section)
To access and compare the incidence of fetal distress.
Drug Intervention:
Two Group
Group MBP- Bala Taila Matra basti, Kebuka Taila Yoni Pichu, Asthapan Basti with Erand Taila and Dashmool Kwath, Tab Misoprostol.
Group BP- Bala Taila Matra basti, Kebuka Taila Yoni Pichu, Asthapan Basti with Erand Taila and Dashmool Kwath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient with 37th week of gestation with singleton pregnancy and cephalic presentation
- •Height 148 to 172cm
- •Hemoglobin more than or equal to 10gm%
- •Patient with borderline or adequate pelvis.
排除标准
- •History of previous LSCS
- •Patient having Bad obstetric history, precious pregnancy
- •Pregnancy associated with severe Pregnancy induced hypertension, Pre-eclampsia, Eclampsia, Gestational Diabetes, Placenta previa, Abruptio placentae, severe oligohydramnios, severe polyhydramnios, severe IUGR
- •Patients suffering with systemic disorders like Diabetes Mellitus, Renal dysfunction, Cardiac disorder, Tuberculosis, Coagulopathies.
- •Patients diagnosed with Benign or Malignant tumor of Reproductive system, Recto vaginal fistula, Vesico-vaginal fistula, second and third degree uterine prolapse
- •History of Fothergill repair, Recto vaginal fistula, Vesico-vaginal fistula
- •VDRL, HIV, HBsAg positive pregnant woman.
结局指标
主要结局
Sukhaprasava (Normal Vaginal Delivery)
时间窗: 45 days
次要结局
- • Differences in the incidence of complications of all four stages of labor and up to 10 days postpartum between the groups(• Differences in the rate of Sukhaprasava (Eutocia) & Shalyajanana (Caesarean section) between the groups)
研究者
Dr Jyoti Singh
National Institute of Ayurveda Deemed to be University(De Novo), Jaipur