الفهرس 
IntroductionOnly 14 pages are availabe for public view
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Abstract
Hydroxychloroquine (HCQ) is a novel medication for people suffering from autoimmune-related recurrent pregnancy loss. Many autoimmune disorders have been related to poor obstetric outcomes, anti-phospholipid syndrome (APS) is the only immune disorder in which pregnancy loss is a diagnostic requirement. The goal of this study is to see how beneficial it is to provide hydroxychloroquine (HCQ) in addition to low-molecular-weight heparin (LMWH) and low-dose aspirin (LDA) to females having a record of autoimmune-related recurrent pregnancy loss and refractoriness to low-dose aspirin and LMWH solely in previous pregnancies, both preconception and during pregnancy.
Between January 2019 and January 2021, 120 females with a record of autoimmune recurrent pregnancy loss at Ain Shams University Maternity Hospital. Participants were divided into two classes using computer based randomization procedures. Preconception and during pregnancy, group A (60 cases) received hydroxychloroquine (HCQ), while group B (60 cases) received a placebo. Also, they received LDA and LMWH. The primary outcome measure in this study was the rate of live births. Secondary outcomes included gestational age at delivery, birth weight, mode of delivery, , Apgar score 5 minutes, neonatal morbidity, rate of neonatal intensive care unit (NICU) admission, and post-natal mortality rate.
The live birth rate was 66% in group A and 42.3 % in group B. So, it was significantly higher in group A than in group B (p value= 0.016). Additionally, gestational age at delivery was substantially greater in group A than in group B. In terms of live births, C-section was slightly less common in group A than in group B (p value= 0.015). Interestingly, the mean birth weight was 2.509 kg in group A and 1.972 kg in group B, indicating that neonatal birth weight was substantially greater in group A than in group B (p value= 0.003). Finally, NICU admission was significantly less common in group -A than in group B (p value= 0.044).
In conclusion, this study showed that adding HCQ to LDA & LMWH has a statistically significant increase in live birth rate and improvement in neonatal outcome, when used in women with history of autoimmune-related recurrent pregnancy loss refractory to LDA & LMWH only. Furthermore, patient, who is negative to conventional aPL and has clinical history of OAPS, has benefits from standard treatment of APS and HCQ.
This outcome has direct impact on neonatal status at delivery and morbidity, mainly by improving overall duration of pregnancy, decreasing the rate of prematurity and low birth weight, in addition to decrease incidence of NICU admission.
This study also has a clinical implication for better understanding the role and effect of HCQ in RPL, in general, and autoimmune disorders in pregnancy especially APS which is the only immune condition in which pregnancy loss is a diagnostic criterion for the disease.
That is also to our knowledge this study one of two RCT studies, the result of another one is not published yet, which are looking at APS pregnant women with randomization to a HCQ group or placebo for follow-up throughout preconception, pregnancy and delivery with an endpoint of the outcome of that pregnancy, including any complications encountered.
Finally, further research with a large sample size is needed to detect evidence based diagnostic criteria for other causes of autoimmune RPL other than APS to detect another role and effect of HCQ.