The Effectiveness of Using Letrozole Prior to Misoprostol Versus Misoprostol Alone for Successful Induction of Medical Abortion: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 主要终点
- Successful medical abortion
研究概览
简要总结
Background and Rationale Abortion accounts for about 8% of maternal mortality worldwide. Surgical intervention is the definitive treatment for abortion but it is invasive. Misoprostol, a PG E1 analogue, is exten¬sively used for induction of abortion with success rate less than 90%. Estrogen is important in the maintenance of pregnancy & aromatase enzyme is essential for its production. Letrozole is an aromatase inhibitor. So we assume that suppression of serum estradiol by letrozole will facilitate termination of pregnancy.
Objectives :
To compare the effect of a combination of letrozole with misoprostol versus misoprostol alone in successful induction of medical abortion.
Study population & Sample size 150 women will be recruited. Women included will be > 18 years with singleton pregnancy of gestational age ≤ 20 weeks having missed abortion. They will be excluded if they have prior CS, twin pregnancy, allergy to letrozole or liver problems.
Study Design :
A randomized controlled trial in which patients will be divided into 2 groups; case group & control group. Each group will contain 75 patients.
Methods :
Case group will receive pretreatment letrozole 12.5 mg for 2 days while control group will receive only misoprostol. Both groups will receive misoprostol in a dosage according to the ACOG guidelines based on gestational age.
Possible Risk (s) to study population :
Major risks (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion). Minor risks (Nausea, diarrhea, headache, weakness, hot flushes).
Outcome parameter (s):
Successful medical abortion i.e. complete abortion with no need for surgical curettage within one week from the 1st dose of misoprostol.
详细描述
Background and Rationale:
Abortion management is one of the most important issues in gyne¬cology. According to the WHO abortion accounts for about 8% of maternal mortality worldwide. The term 'abortion' has become synonymous with induced abortion which is an intentional termination of pregnancy but it also includes spontaneous abortion.
Induced abortion is thus one of the most commonly investigated topics in gynecology as means to achieve safe abortion in order to reduce associated maternal morbidity & mortality.
Abortion is defined as the termination of a pregnancy before the 20th week of pregnancy or termina¬tion of pregnancy before the fetus weighing 500 g.
Surgical intervention is the definitive treatment for abortion. However, it is invasive and is not necessary for all females. Curettage may be avoided via expectation and medi¬cal treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy.
- •Primigravida or multigravida.
- •Gestational age ≤ 20 weeks.
- •Missed abortion.
排除标准
- •Maternal age < 18 years.
- •Twin pregnancy.
- •Previous cesarean section.
- •Allergy to letrozole or misoprostol.
- •Liver cirrhosis or severe liver impairment.
研究组 & 干预措施
Case group
Case group will receive pretreatment letrozole 12.5 mg for 2 days before administration of misoprostol in a dosage according to ACOG guidelines based on gestational age.
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
Successful medical abortion
时间窗: One week from the 1st dose of misoprostol.
Number of participants who achieved complete abortion with no need for surgical intervention in each group
次要结局
未报告次要终点
研究者
Amr Fathy Zaky
Assistant Lecturer
Cairo University