HYPATIA: A prospective randomised controlled trial of HYdroxychoroquine to improve Pregnancy outcome in women with AnTIphospholipid Antibodies

Research summary

Patients with antiphospholipid antibodies (aPL) may have an increased risk of having blood clots and women with aPL may have problems during pregnancy. In the presence of aPL blood becomes more ‘sticky’ than usual. aPL occur in about 1% of the population. Knowing that there are 800,000 births a year in the United Kingdom, this means 8,000 pregnancies affected by aPL every year. Women with aPL are more likely to have pregnancy loss and/or small babies and/or pre-eclampsia (high blood pressure and protein in the urine). During the first twelve weeks of pregnancy, aPL can limit the growth of the early cells. In the later weeks of pregnancy, it can cause blood clots to occur in the placenta. This means that the placenta is unable to supply the fetus with enough nutrition, so the fetus may grow slowly (intrauterine growth restriction) and in extreme cases may die. Some mothers in this situation also develop pre-eclampsia. Current treatment for pregnant women with aPL is to give blood thinners (antithrombotic medication) such as aspirin tablets, and sometimes heparin injections This has improved the live-birth rate to > 70%. We have looked back at our female patients in St Thomas’s with aPL who were given hydroxychloroquine (HCQ) during pregnancy to treat a related disease called lupus (or systemic lupus erythematosus). We found that those taking HCQ had a better pregnancy outcome compared to women who did not take it, with fewer miscarriages & preterm births and a higher live birth rate. The purpose of the HYPATIA study is to answer the question as to whether HCQ may help improve pregnancies in women with aPL. We are therefore proposing the first ‘randomised controlled trial’, treating consenting women with aPL either with HCQ or placebo throughout pregnancy in addition to their usual medications, and comparing the pregnancy outcomes.

Principal Investigator

Dr Ingrid Granne

Contact us

Email: osprea@wrh.ox.ac.uk

IRAS number

170254