Letrozole versus mifepristone pre-treatment with misoprostol in medical termination of pregnancy; A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare effectiveness of Letrozole versus Mifepristone pre-treatment with Misoprostol in medical termination of pregnancy of gestation equal to or less than 9 weeks
研究概览
简要总结
Induced abortions can be performed by medical and surgical methods.The standard of care for TOP has shifted from a predominantly surgical approach towards medical strategy. Medical termination of pregnancy has increased in popularity worldwide as it is non-invasive , there is avoidance of risks associated with surgery, cost effective and with a high level of patient satisfaction.
Various agents have been assessed in combination with misoprostol to improve success of mTOP including mifepristone, gemeprost and tamoxifen .
In general mTOP involves using either a combined regimen consisting of mifepristone and misoprostol which is the current gold standard of care, or a misoprostol-only regimen. WHO recommends the use of mifepristone for pre-misoprostol priming when mifepristone is available, and an alternative of misoprostol-only when mifepristone is not accessible. Compared with misoprostol alone, pre-treatment with mifepristone followed by misoprostol has been shown to improve the success rate of complete abortion.
Worldwide access to mifepristone, despite being developed in 1980 , is limited and it is expensive .Hence there is an urgent unmet need for a cheaper and more readily available alternative. Letrozole priming before mTOP has been proposed as an alternative to the use of mifepristone by who.
The successfull completion of this RCT may lead to the introduction of a more costeffective and easily accessible mTOP service for patients, as letrozole is cheaper and more widely available as compared to mifepristone .
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
- •Women with age 18 to 40 years
- •Singleton pregnancy
- •Gestational age less than or equal to 9 weeks or 63 days of amenorrhea based on history, clinical examination, or ultrasonography if required
- •Patient requesting for mTOP and eligible for legal abortion according to the Termination of Pregnancy act.
排除标准
- •1.Inevitable or incomplete abortion 2.Suspected ectopic pregnancy 3.Anemia (Hemoglobin less than 8gm %) 4.Any history suggestive of drug allergy or allergy to mifepristone ,misoprostol or letrozole drugs 5.Presence of maternal disease such as cardiovascular disease, liver failure , respiratory distress ,asthma , adrenal insufficiency, renal failure , history of thromboembolism and on anticoagulant therapy
- •Any history of joint pain and stiffness , osteoporosis .
结局指标
主要结局
To compare effectiveness of Letrozole versus Mifepristone pre-treatment with Misoprostol in medical termination of pregnancy of gestation equal to or less than 9 weeks
时间窗: 2 weeks
次要结局
- Incomplete abortion(Yes)
- Complete abortion(Yes)
- Total no. Of misoprostol dose required(Given 4 hourly if signs of expulsion are not evident)
- Need for incomplete evacuation(Yes)
研究者
Dr Vinus Bansal
Dr RPGMC Kangra at Tanda Himachal Pradesh