A Pilot Study of Atorvastatin as a Potential Adjunct to Misoprostol for Termination of Pregnancy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Interference in pregnancy progress
研究概览
简要总结
Medication abortion is a way of ending a pregnancy using pills. The current FDA-approved regimen for medication abortion uses mifepristone and misoprostol. This study is testing whether a different medication, atorvastatin, followed by misoprostol, can be used to end a pregnancy. Participants at 35-49 days of pregnancy will receive an oral dose of atorvastatin (80 mg) to swallow at the clinic as well as taking atorvastatin (80 mg) daily for six additional days, with a return to clinic on day 8 after initial visit to take a dose of misoprostol (800 mcg). Additionally, follow-up visits will occur on approximately days 3, 8 and 11 for a clinician to perform an ultrasound to see if the abortion is complete.
详细描述
Safe and legal abortion is an important part of reproductive health. Medication abortion using a combination of mifepristone and misoprostol is recognized worldwide as the gold standard for early medication abortion. Finding another medication that replace mifepristone would benefit both those who need abortions and providers around the world. Atorvastatin might be one drug that could do this. It is a statin that is commercially available in many countries.
Goal: To evaluate the safety and effectiveness of a user-friendly atorvastatin-misoprostol regimen
Primary Objective: Successful interference in pregnancy progress, decreases in measurable human chorionic gonadotrophin (HCG) hormone, or an end of pregnancy (prior to misoprostol use) within seven days of starting atorvastatin (80 mg per day for seven days).
Sample Size: 30 patients
Location: Recruitment of all participants and data collection will take place at Planned Parenthood Association of Utah.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •A pregnancy confirmed as 35-49 days gestational age through transvaginal ultrasound
- •Seeking termination of pregnancy
- •Speak English or Spanish
- •Willing to potentially delay abortion for 1-2 weeks
- •Willing and able to comply with study protocol and accept that the study regimen may not successfully terminate the pregnancy thus a uterine aspiration would be required to complete the abortion.
- •Willing to delay contraception until completion of abortion
排除标准
- •People with pregnancy over 49 days gestational age
- •Twin or higher multiple pregnancy
- •Medical contraindications to medical abortion per the mifepristone U.S. Food and Drug Administration label
- •Confirmed or suspected ectopic pregnancy
- •Vaginal bleeding in current pregnancy
- •Pregnancy of unknown location
- •IUD or contraceptive implant in place
- •History of allergy to atorvastatin or misoprostol
- •History of myositis
- •Currently taking or planning on taking medications during the study that interact with HMG co-A reductase inhibitors (e.g., diltiazem, erythromycin, azoles, gemfibrozil or another fibrate)
- •Unable to return for clinic-based follow-up
- •Currently breastfeeding
- •Already taking an HMG co-A reductase inhibitor [37] or plan to take one outside the study drug during the trial (Fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or rosuvastatin.
- •Unable to swallow pills
研究组 & 干预措施
Experimental: Atorvastatin followed by misoprostol
Oral dose of atorvastatin (80 mg) to be taken daily for seven days followed by misoprostol (800 mcg) on day 8. A second dose of misoprostol will occur 24 hours after the first dose if no significant bleeding (more than a regular period) has occurred.
干预措施: Atorvastatin (Drug)
Experimental: Atorvastatin followed by misoprostol
Oral dose of atorvastatin (80 mg) to be taken daily for seven days followed by misoprostol (800 mcg) on day 8. A second dose of misoprostol will occur 24 hours after the first dose if no significant bleeding (more than a regular period) has occurred.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Interference in pregnancy progress
时间窗: Within 7 days of initiating atorvastatin (80 mg per day)
This is a dichotomous outcome that includes interference in pregnancy progress by any of the following: 1) ultrasound markers as measured by transvaginal ultrasonographic loss of embryonic cardiac activity if previously documented, or 2) abnormal ultrasonographic growth over seven day period consistent with the "Diagnostic Criteria for Nonviable Pregnancy Early in the First Trimester" (this includes "findings suspicious for, but not diagnostic of, pregnancy failure" which encompass no visualization of an embryo seven days after a gestational sac is seen, N Engl J Med 2013;369:1443-51.), 3) any decrease in human chorionic gonadotrophin measures, or 4) an insufficient rise in quantitative HCG if baseline HCG is ≤5000 including: a decrease or increase of less than 50% in quantitative HCG from day 1 to 3; a decrease or increase of less than 100% in quantitative HCG from day 3 to 8, or 5) passage of the pregnancy confirmed by ultrasound prior to misoprostol use.
次要结局
未报告次要终点