Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) - et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium
试验速览
- 阶段
- 3 期
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Live birth
研究概览
简要总结
Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious).
There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy.
This study has the potential to establish support for a new treatment option for unexplained RPL.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL
- •≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss.
排除标准
- •Age below 18 years or above 39 at inclusion
- •Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography
- •Chromosomal abnormalities within the couple
- •Menstrual cycle below 23 days or above 35 days
- •Lupusantikoagulans positivity or immunoglobulin (Ig)G/IgM anticardiolipinantibodies (≥10 GPL kU/l at Rigshospitalets Laboratorium) or plasma homocystein ≥25 mikrogr./l at repeated measurement with 12 weeks interval.
- •HIV or Hepatitis B or C positive
- •Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)
- •Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents
- •Hemoglobin ≤ 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion
- •Previous treatment with HCQ in pregnancy
- •>1previous live birth
- •previous participation in this trial
研究组 & 干预措施
Hydroxychlorochine HCQ
Women in the experimental arm will take 200 mg HCQ tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
干预措施: Hydroxychloroquine (Drug)
Hydroxychlorochine HCQ Placebo
Women in the experimental arm will take 200 mg HCQ placebo tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
干预措施: Hydroxychloroquine placebo (Drug)
结局指标
主要结局
Live birth
时间窗: At delivery
次要结局
- Gestational age(up to at delivery)
- Live birth after exclusion of patients with a chromosomal abnormal pregnancy loss, extrauterine pregnancy loss, intended abortion or patients with insufficient intake of study medicine(At delivery)
- Admittance to neonatal unit(Within 28 days of delivery)
- Birth weight(At delivery)
- Immunological status(Up to two years after end of study)
研究者
Henriette Svarre Nielsen, MD, DMSc
Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor
Rigshospitalet, Denmark