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

Pregnancy | Venous Thrombosis | Autoimmune Disorders

Women with antiphospholipid antibodies are more likely to have pregnancy complications, and antiphospholipid syndrome is a serious acquired blood clotting condition. Pregnancy complications may include recurrent or late pregnancy loss, placental problems like pre-eclampsia (high blood pressure and protein in the urine) or growth restriction (small babies), or blood clotting problems.

Low-dose aspirin and/or injectable blood thinners called low-molecular-weight heparin are used for patients with antiphospholipid antibodies or antiphospholipid syndrome to prevent recurrent pregnancy complications or blood clots. However, pregnancy complications still occur despite our best therapies of aspirin and injectable blood thinners.

The purpose of this research study is to find out whether a drug called hydroxychloroquine may help improve pregnancies in women with APS. This is a drug that is safe in pregnancy, and is used for other indications.

This study is a randomized controlled trial, which means that a participant would either receive hydroxychloroquine or a placebo drug. This would start before pregnancy, and continue during pregnancy. Follow-up would occur before pregnancy, during pregnancy, and after pregnancy.

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Participation Requirements

  • Sex:

    Female

  • Eligible Ages:

    18 to 45

Participation Criteria

Inclusion Criteria:
1. 18 to 45 years of age.
2. Have persistently positive antiphospholipid antibodies
3. Planning pregnancy.
Exclusion Criteria:
1. Currently pregnant.
2. Allergy to hydroxychloroquine.
3. Currently taking hydroxychloroquine.
4. Age <18 and >45 years.
5. Body weight <45 kg.
6. Psoriasis.
7. Uncontrolled epilepsy.
8. Anti-Ro antibodies.
9. Renal replacement therapy.
10. HIV, hepatitis B, severe gastrointestinal, liver, cardiac, neurological or blood disorders.
11. Porphyria.
12. History of retinopathy or newly diagnosed retinopathy.
13. History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
14. History of glucose-6-dehydrogenase deficiency.
15. Participation in any other study drug trial.
16. Previous pregnancy loss while taking hydroxychloroquine.
17. Changes in heart rhythm (prolonged QTc) on an ECG (electrocardiogram).

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB22-1640