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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Karen
Schreiber
kschreiber@danskgigthospital.dk
Prof
Beverley
Hunt
beverley.hunt12@nhs.net
Women with persistent antiphospholipid antibodies who are planning pregnancy
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Antiphospholipid syndrome (APS) is the combination of persisting antiphospholipid antibodies (aPL) and a previous thrombosis (blood clot) and/or pregnancy problems. Antibodies are part of the immune system, and can sometimes be directed against part of our own cells, this is known as autoimmune disease, and APS is such a problem. aPL occur in about 1% of the population, so extrapolating this to a birth rate of 800,000/year in the UK, this means 8,000 women with aPL are giving birth every year.
Women with aPL (this term includes those with APS) are more likely to have pregnancy loss. During the first 12 weeks of pregnancy, aPL can inhibit the growth of the early fetal cells and later cause blood clots in the blood vessels of the placenta in the second and third trimester (14-36 weeks). This means that the placenta is unable to supply the fetus with enough nutrition, so the fetus may stop growing, grow slowly (intrauterine growth restriction) and in extreme cases may die. Some mothers in this situation also develop pre-eclampsia (high blood pressure during pregnancy and after labour).
Pregnant women with aPL are treated with aspirin, and sometimes heparin, depending on whether they had blood clots and/or obstetric problems before. This has improved the live birth rate to over 70%.
A study of women with aPL who were taking hydroxychloroquine (HCQ) during pregnancy to treat lupus found that women taking HCQ had a better pregnancy outcome compared to women who do not take it, with fewer miscarriages and preterm births and a higher live birth rate. HCQ is safe in pregnancy, well-tolerated, and costs only £0.10 per tablet in the UK.
To find out more about this, in this study women with aPL are treated either with HCQ or a placebo (dummy drug) throughout pregnancy in addition to their usual medications, and pregnancy outcomes are compared.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28609801/ protocol (added 27/08/2020)
You can take part if:
You may not be able to take part if:
1. Women who are already pregnant2. Allergy or adverse event to hydroxychloroquine. Hypersensitivity to the active substance, 4-aminoquinoline or any of the compounds of the IMP or placebo3. Current treatment with hydroxychloroquine4. Age < 18 and > 455. Bodyweight < 45 kg6. Psoriasis7. Uncontrolled epilepsy8. Anti-Ro antibodies9. Renal replacement therapy10. Other severe active co-morbidities (HIV, hepatitis B, severe gastrointestinal, neurological or blood disorders)11. Porphyria12. History of retinopathy or newly diagnosed retinopathy13. History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption14. History of glucose-6-dehydrogenase deficiency15. Participation in any other IMP trial at the time of consent16. Previous pregnancy failure on hydroxychloroquine
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Guy's and St Thomas' NHS Foundation Trust and funded by Research for Patient Benefit Programme; Guy's and St Thomas' Charity.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS: 37234
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
