DefinePK

Abstract

Introduction: Antiphospholipid antibody syndrome (APS) is the primary treatable etiology of recurrent pregnancy loss (RPL). Hydroxychloroquine (HCQ) is extensively used in the treatment of individuals with autoimmune disorders; HCQ facilitates the restoration of trophoblast fusion impaired by autoantibodies.This study was to evaluate the effectiveness of adjuvant HCQ therapy on pregnancy outcomes in pregnant women experiencing RPL due to anti-phospholipid antibody syndrome that is resistant to standard treatment with low-dose aspirin (LDA) and prophylactic low-molecular-weight heparin (LMWH).
Methodology: This randomized controlled clinical trial involved 100 pregnant women, who were evenly allocated into two groups. The HCQ group received adjuvant HCQ 200 mg tablets twice daily until the conclusion of pregnancy, along with LDA until the 35th week of gestation, and LMWH during pregnancy and for 3–6 weeks postpartum. The control group was administered only low-dose aspirin and LMWH. Subsequent appointments were arranged in accordance with established norms.
Results: Gestational age at delivery was statistically significant higher among HCQ group 33.1±5.5 vs. 24.8±7.5 weeks with higher live birth rate and lower percent of fetal loss; 34.0±3.1 vs. 32.5±4.0 and 22.8±2.3 vs. 24.2±5.4 respectively. Bleeding or thrombotic events were statistically significant lower among HCQ group 4 (8%) vs. 10 (20.0%) respectively. During pregnancy and postpartum maternal thrombotic events were 3 (6.0%) vs. 5 (10.0%) and 1 (2.0%) vs. 7 (14.0%) respectively. Neonatal birth weight and Apgar score ≥ 7.0 were statistically significant higher among HCQ group; 2.600±0.611 vs. 2.125±0.215 gram and 27(54.0%) vs. 10(20.0%) respectively. The need for NICU admission was lower among HCQ group; 3(6.0%) vs. 16(32.0%). Postnatal maternal mortality rates were lower among HCQ group; 20(40%) vs. 34(68%).
Discussion: The use of HCQ for obstetrical APS is a potential treatment option to improve maternal and neonatal outcomes