A Randomized Double-blind Placebo-controlled Trial Comparing Letrozole Versus Mifepristone As Pre-treatment Before Medical Management of First Trimester Silent Miscarriage Using Misoprostol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 884
- 主要终点
- Gestational sac expulsion
研究概览
简要总结
Management of first trimester silent miscarriage can be by expectant, medical or surgical management. Surgical management by suction evacuation is associated with surgical risks (including risks to the womb that can affect further pregnancy), anaesthetic risks and hospital stay. Medical management of first trimester silent miscarriage using misoprostol is another common option that can reduce the risk of bleeding and those associated with surgery. However, the current standard management of using misoprostol for the management of first trimester miscarriage only has a success rate of 70-80%, which is suboptimal.
Recent large studies have shown that adding mifepristone pre-treatment before misoprostol in the management of silent miscarriage can improve the success rates of complete miscarriage after medical management. There are 2 problems with mifepristone. Firstly, it is not widely available in many countries for cultural and religious reasons because it is labelled as an 'abortifacient'. Secondly, it is expensive. One tablet of Mifepristone costs $500 HK dollars. There is a need to look for an alternative to mifepristone.
Letrozole is an aromatase inhibitor which can reduce estrogen levels. Some studies have shown that it can improve the success rate of medical management of silent miscarriage and termination of pregnancy. It is safe, more widely available and cheaper than mifepristone.
This is a randomized double blinded trial comparing the use of mifepristone versus letrozole as pre-treatment in the medical management of first trimester silent miscarriage using misoprostol.
详细描述
This is a randomized double blinded trial comparing the use of mifepristone versus letrozole as pre-treatment in the medical management of first trimester silent miscarriage using misoprostol.
Both groups will receive misoprostol (which is the standard management for medical management of silent miscarriage locally), but they will be randomized to either adding mifepristone or letrozole as pre-treatment. Mifepristone is usually taken once 2 days before misoprostol, whereas letrozole is taken 10mg daily for 3 days before misoprostol. Placebo of letrozole and mifepristone will be given to maintain double blindness of the groups.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with silent miscarriage <= 12 weeks of gestation by ultrasonography
- •Single intrauterine gestational sac
- •No heavy per-vaginal bleeding
- •No severe abdominal pain
- •No features of intrauterine infection
- •Able to understand the proposed research and able to comply with instructions
- •Having given voluntary written informed consent
排除标准
- •Known allergy to mifepristone, misoprostol or letrozole
- •On drugs with potential drug interactions with mifepristone e.g. aspirin, clopidogrel, anti-coagulants etc.
- •Suspected ectopic or molar pregnancy or multiple pregnancy
- •Distorted uterine cavity by uterine septum or submucosal fibroids
- •Presence of intrauterine contraceptive device
- •History of bleeding tendencies e.g. haemorrhagic diseases, current anti-coagulant treatment
- •Previous history of retained products of gestation/ failed medical management of miscarriage
- •Opt for expectant or surgical management of miscarriage
研究组 & 干预措施
Letrozole
Letrozole 10mg per day from day 1-3 orally, placebo mifepristone Sublingual misoprostol 800 microgram on day 3
干预措施: Letrozole (Drug)
Mifepristone
Mifepristone 200mg orally on day 1, placebo letrozole on day 1-3 Sublingual misoprostol 800 microgram on day 3
干预措施: Mifepristone (Drug)
结局指标
主要结局
Gestational sac expulsion
时间窗: 2 weeks, 30 days
Gestational sac expulsion by the first follow up visit after 2 weeks of misoprostol administration and no additional surgical or medical intervention within 30 days after randomization
次要结局
- Time of tissue expulsion(6 weeks)
- Return of normal menses(6 weeks)
- Requirement of repeated intervention(6 weeks)
- Unplanned re-admission(6 weeks)
- Analgesics(6 weeks)
- Side effects(6 weeks)
- Vaginal bleeding(6 weeks)
- Complications(6 weeks)
- Return of menstruation(6 weeks)
- Women's satisfaction(6 weeks)