STUDY THE EFFICACY OF EVOKE GEL (ADHATODA VASICA) LOCAL APPLICATION NABHI BASTI BHAGA TO INITIATE UTERINE CONTRACTIONS BEYOND 41 WEEKS OF GESTATION WITH SPECIAL REFERANCE TO LABOUR INDUCTION:OPEN RANDOMIZED CONTROL CLINICAL STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To determine the efficacy of "Evoke Gel(ADHATHODA VASACA)" in initiating uterine contractions beyond 41 weeks of gestation in cases of labor induction.
研究概览
简要总结
Induction of labor is the initiation of uterine contractions before the spontaneous onset of labor with or without ruptured of membranes. By medical or surgical means for the purpose of delivery. It may be categorized as elective or indicated. In general, induction of labor may be indicated when the benefit of delivery to the mother and fetus outweighs the potential problem if the pregnancy continues. There may be maternal or fetal indications. These conditions may arise if the maternal medical or surgical condition worsens under expectant therapy or if there is evidence of impaired intrauterine existence. If obstetric data confirm that the pregnancy is at term or if fetal pulmonary maturity has been documented, the decision to induce labor is not difficult. When the cervix is closed and uneffaced, labor induction is often preceded by cervical ripening, a process to soften and open the cervix. This is somewhat of a misnomer in that cervical ripening, per se, may also be a means of labor induction. Prolonged pregnancy or postulates has been defined in the literature on the basis of weeks completed frogs the first day of the last menstrual period (LMP) Definitions have ranged from 41 to 43 completed weeks. The most often used definition is 42 completed weeks. The incidence of prolonged pregnancy has been reported to range from 3.5 to 14 percent of all pregnancies.
Adhatoda vasica is a good source of pyrroloquinazoline alkaloids such as vasicine, vasicol, adhatonine, vasicinone, vasicinol, vasicinolone etc. Uterine stimulant activity and moderate hypotensive activity of the alkaloidshave been observed. Vasicine is metabolized to vasicinone. leaf extract showed that it contained 0.85 percent vasicine and 0.027 percent vasicinone. Adhatoda vasica possesses abortifacient and uterotonic properties due to the presence of vasicine in its extracts. The compound initiated rhythmic contractions of human myometrial strips from both non-pregnant and pregnant uterus. It indicating that the action of vasicine was probably enhanced by the synthesis and release of prostagladins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.In married women with age group of 21-35 years.
- •2.Post-term, post-maturity, post-dated pregnancy.
- •3.Singleton live pregnancy with normal AFI.
- •4.Cephalic presentation of fetus irrespective of gravida status.
- •5.Gestational age greater than 41 weeks.
排除标准
- •1.Gestational age less than 37 weeks 2.Contracted pelvis and cephalopelvic disproportion 3.Abnormal presentation 4.Active genital herpes infection 5.Previous uterine surgery like L.S.C.S, Fibroid 6.Gravida with systemic or other medical disorders.(DM,HTN) 7.High risk pregnancy including jaundice, preeclampsia, anemia, PIH 8.Precious pregnancy
- •Patients are excluded with no previous reports of CBC,USG.
结局指标
主要结局
To determine the efficacy of "Evoke Gel(ADHATHODA VASACA)" in initiating uterine contractions beyond 41 weeks of gestation in cases of labor induction.
时间窗: Ninety minutes
次要结局
- To assess the role of Dinoprostone gel vaginal application for induction of labor beyond 41 weeks of gestation(Twelve to Twenty four hours)
研究者
Dr Meghana Anand Nikum
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali Maharashtra India
