Hydroxychloroquine For Improvement Of Pregnancy Outcome In Unexplained Recurrent Miscarriage: A Randomized Controlled Trial

Background: Recurrent miscarriage (RM) is unexplained in about 50% of cases. We evaluate the efficacy of hydroxychloroquine in improving ongoing pregnancy rate at 20 weeks' gestation in women diagnosed with unexplained recurrent miscarriage.Methods: This is a randomized controlled trial, prospectively registered on ClinicalTrials.gov (NCT04228263).It was conducted at outpatient clinic, Women's Health Hospital (WHH), Assiut University, Egypt from January 1, 2020, to July 8, 2023. Eligibleparticipants were prospectively randomized to either Group I (n= 78) received 200 mg of oral HCQ twice daily, alongside folic acid supplementation or Group II (n= 78) received folic acid alone.Low-dose aspirin (75mg)was started upon confirmed pregnancy in both groups.Results: The Ongoing pregnancy rate at 20 weeks gestation consistently trended higherin Group I (HCQ) n= 53/78(67.9%) than those in Group II (control) n= 45/78(57.7%). Analysis of ongoing pregnancies at 20 weeks found that the absolute risk reduction (ARR) was 10.3% (CI= -4.83%, 25.34%) so the number needed to treat (NNT) was 10.There was no statistical difference between both study groups regarding live birth rate, neonatal outcomes and pregnancy complications (FGR, preeclampsia, preterm delivery).Conclusion: HCQ did not significantly enhance the ongoing pregnancy rate at 20 weeks gestation and had no effect on the risk of preeclampsia, FGR and preterm birth in women with unexplained recurrent miscarriage. HCQ appears to be safe to the fetus with few maternal side effects to mothers.