Randomized controlled trial to evaluate efficacy of Sukhaprasavkar Lepa with Dinoprostone gel in the management of Prakrut Prasav with special reference to Induction of Labour.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Monitoring of Progress of labour will be observed with help of Modified Bishops score
研究概览
简要总结
In developed countries, up to 25% of all deliveries at term now involve induction of labour. In developing countries, the rates are generally lower. The study revealed the prevalence of induction of labor in India to be 9%, which is very low in comparison to the rate of other institutions in developed countries. Bishop’s score after cervical ripening significantly predicted success of induction and induction was eight times more likely to succeed if the Bishops score was Favorable. WHO Global survey on Maternal and Perinatal Health, which included 373 health-care facilities in 24 countries and nearly 300000 deliveries, showed that 9.6% of the deliveries involved labour induction.
Our Acharyas have described antenatal care (Garbhini Paricharya) for nine months of pregnancy and has mentioned the use of enema (Anuvasan Basti) and vaginal tampon (Yoni Pichu) of medicated oil prepared with drugs mentioned in Madhur Sakandh 10 (group of drugs) during ninth month. Also, they described various methods for sukhaprasava during labour; one of them is application of herbal paste (Sukhprasavkar Lepas) at the onset of labour for easy and safe delivery.
The study was designed to evaluate the effect of medicated pastes applied on and around umbilicus named as Sukhprasavkar Lepa described by Bhavaprakash and Yogratnakara for evaluating effect on progress of labour, cervical dilatation, Bishop’s score, duration of stages of labour and pattern of uterine contractions for augmentation of labour.
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
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients in first stage of labour having one of the following indications for induction of labour.
- •Postdated pregnancy 41 weeks b.
- •At 39 weeks in low-risk pregnancy c.
- •(PROM) and Preterm Prelabor Rupture of Membranes (PPROM) d.
- •Hypertensive disorders in pregnancies.
- •(Preeclampsia) e.
- •Fetal Growth restriction.
排除标准
- •1 Patients contraindicated for Induction of Labour 2 Age below 18and above 40 years 3 Elderly primigravida (above 35 years) and Grand Multipara (G6) 4 Patients having Diabetes or Anemia (Hb less than 8gm) 5 Intrauterine Fetal Demise 6 Previous Cesarean section.
结局指标
主要结局
Monitoring of Progress of labour will be observed with help of Modified Bishops score
时间窗: after 18 hours
Mode of Labour will be observed - Normal Vaginal delivery or Cesarean section after 18 hours
时间窗: after 18 hours
次要结局
- Modified Bishops Score(after every 6 hours)
研究者
Dr Swati Bhagwan Bali
PMTs Ayurved college
