A Prospective observational study for estimation of the adverse drug reactions in female subjects using oral contraceptive pills.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- To evaluate the ADRs related to use of OC pills in three months duration
研究概览
简要总结
This study is planned to understand the prescribing pattern of oral contraceptive pills and their side effects in a tertiary care hospital and its aim is toestimate the adverse drug reactions in female subjects using oral contraceptive pills. Our research question is what isthe percentage of Adverse drug reactions in female subjects consuming OC pills in the duration of three months. Through this study we also want to know oral contraceptive pills non contraceptive uses in polycystic ovarian disease , menstrual disorders , hormone replacement therapy etc. It is a prospective observational study carried out during one year. Patient follow up is done for adverse drug reactions for minimum 3 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1]Women of the age group 18-60 years freshly prescribed OC pills 2]Women using OC pills for at least 1 month 3]Women who can recall ADR events.
排除标准
- •Women with chronic diseases like Hypertension, DM, Kidney disease and Liver disease.
结局指标
主要结局
To evaluate the ADRs related to use of OC pills in three months duration
时间窗: three months duration
次要结局
- To estimate the proportion of female subjects using OC pills for contraceptive and non- contraceptive purpose.(To determine the perception of female subjects about OC pills)
研究者
Dr Aishwarya Dhakne
Bharati Vidyapeeth deemed to be university medical college, Pune