A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Continuing Pregnancy Based on Ultrasound Examination
研究概览
简要总结
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
详细描述
Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. The use of medications to cause abortion has been around for almost 70 years but the modern era of medical abortion treatment evolved with the development of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater than progesterone itself.
Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of continuing pregnancy is still present, especially as gestation advances. While most women opt for further treatment in these scenarios, such as surgical aspiration, there are some who decide to continue the pregnancy. Thus, even following treatment, some women do change their mind.
No well-done study has evaluated whether such treatment works. Poorly controlled case series are not evidence and systematic reviews of continuing pregnancy rates after mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This study is also a first step to understanding if large studies evaluating mifepristone antagonization with high-dose progesterone are indicated and if placebo-controlled randomized trials can be successfully completed when evaluating this question.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
placebo pills in opaque bottle
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females 18 years and older at enrollment.
- •Seeking surgical abortion at 44-63 days' gestation on Study day
- •Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
- •Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
- •English-speaking
- •Willing to sign informed consent and follow study protocol.
- •Willing to experience potential expulsion of the pregnancy with mifepristone treatment.
排除标准
- •Medical contraindications to medical abortion.
- •Poorly controlled hypertension (systolic BP >160 or diastolic BP >95)
- •Significant anemia - known recent hemoglobin <9.5 gm/dL
- •Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
- •Breastfeeding
- •Coagulopathy or therapeutic coagulation
- •Ultrasound evidence of molar or ectopic pregnancy
- •Chronic systemic corticosteroid use
- •Adrenal disease
- •Sickle cell anemia with frequent/recent crises
- •IUD in place during conception, even if removed.
- •Peanut allergy.
- •Known intolerance of mifepristone or progesterone.
- •Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.
研究组 & 干预措施
Progesterone
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
干预措施: Mifepristone 200 MG (Drug)
Progesterone
Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1).
Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.
干预措施: micronized Progesterone (Drug)
Placebo oral capsule
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
干预措施: Mifepristone 200 MG (Drug)
Placebo oral capsule
Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Continuing Pregnancy Based on Ultrasound Examination
时间窗: at 14-16 days after mifepristone administration
Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination
次要结局
- Number of Participants With Adverse Events During Follow-up Evaluation(up to 16 days after mifepristone administration)
- Expulsion During Follow-up Evaluation(up to 16 days after mifepristone administration)
- Medical Safety During Treatment and Follow-up(up to 16 days after mifepristone administration)
- Number of Participants With Change in Serum Progesterone and hCG During Follow-up(up to 16 days after mifepristone administration)