Hydroxychloroquine treatment for Recurrent Pregnancy Loss: a randomized double-blind placebo-controlled trial
- Conditions
- Recurrent Pregnancy LossTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2024-515579-36-00
- Lead Sponsor
- Hvidovre Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 186
= 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained recurrent pregnancy loss (RPL), = 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss
Age < 18 years or > 40 years, Previous HCQ treatment in relation to conceive, > 1 previous live birth., Previous participation in current study., Prominent uterine abnormalities detected by hysterosalpingography/hysteroscopy or hydrosonography, Known prominent chromosome abnormalities for the couple trying to conceive, A menstrual cycle < 23 days or > 35 days if the pregnancy is conceived naturally. If the woman received fertility treatment the menstrual cycle has no consequence., Detection of positive lupus-anticoagulant or positive IgG/IgM for anticardiolipin-antibodies (=10 GPL kU/l, measured at the same laboratories at the Capital Region of Denmark) or plasma homocysteine =25 microgram/l by repeated measurements 12 weeks apart before the pregnancy., Positive HIV test or test indicating chronic hepatitis B or C., Psoriasis, retinopathic or serious hearing deficiency (contraindication for treatment with HCQ), Current chronic disease implicating a constant consumption of immunomodulatory medicine or medicine potentially harmful to the pregnancy/embryo, Hgb = 6.5 mmol/L, leucocytes < 3.5 E9/L, thrombocytes < 145 E9/L by the time of inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method