الفهرس 
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Abstract
Recurrent miscarriage is one of the most frustrating and difficult areas in reproductive medicine, since the etiology is often unknown and evidence-based diagnostic and treatment strategies are conflicting. About 50% of RM are unexplained (De Moreuil et al., 2020). Many studies used different therapeutic options for management unexplained RM but no treatment had clearly proven benefits. Hydroxychloroquine is an immunomodulatory drug and many studies reported its role in improvement of placental function and pregnancy outcomes when used with certain immunological disorders during pregnancy. Hydroxy-chloroquine is often prescribed to women with unexplained recurrent miscarriage, although evidence suggesting a benefit is awaited.
So, the aim of our study was to determine whether HCQ increases ongoing pregnancy at 20 weeks gestation and live-birth rates in women with unexplained RM.
The study was a single-center, randomized open-labeled clinical trial. It was registered prospectively at Clinicaltrial.gov (NCT04228263). The study recruited women with previous 2 or more miscarriage aged 20 -40 years with BMI 18.5-35 Kg/m2. Also, the included women had no anatomical, endocrine or autoimmune causes of RM However, we excluded women already using HCQ or pregnant, had any contraindication for HCQ or with history of infertility.
Eligible women were randomized equally to either group I: HCQ group or group II: Non HCQ group. A blocked randomization was done, and a table of random numbers was generated. The eligible patients were assigned preconceptional to receive either 400 mg of oral HCQ per day, administered in two divided doses of 200 mg plus folic acid 500 Mg or folic acid 500 Mg only then low dose aspirin 75 mg added two both study groups once pregnancy test was positive. Hydroxychloroquine was stopped at 12 weeks’ gestation or after 12 months of treatment in the absence of pregnancy.
During preconceptional period, the eligible patients were followed up monthly for ovulation monitoring to increase success rate of patients to get pregnant. Then during pregnancy, patients in both groups were regularly observed. Six visits were planned at 6th, 12th, 20th, 28th, 34th and 37th weeks of pregnancy. In each scan, confirmation of fetal viability was done in addition to searching for any congenital malformations, any pregnancy complications or side effects of the therapy. Also all delivery data regarding gestational age of delivery, mode of delivery, birth weight and need for NICU admission was reported.
The sample size was calculated and total number of scheduled patients to be recruited was 156 (78 patient’s on each study group).
Both groups were homogenous in baseline and demographic data without statistically significant differences (Age, BMI, Consanguinity, and duration from last abortion Parity, previous CS). There was higher ongoing pregnancy rate at 20 weeks gestation in HCQ group than no intervention group, however there was no statistically significant difference between both study groups (67.8% vs 57.7 % p= 0.185). Also more improvement in live birth rate was detected with HCQ use but the difference was not statistically significant (65.3% vs 52.5%, p=0.409). Also, no statistical significant difference in neonatal outcomes or pregnancy complication as preeclampsia, fetal growth restriction, preterm birth and intrauterine fetal deaths between both study groups.
HCQ was well tolerated, and no serious side effects were observed. HCQ had excellent safety profile to the fetus with few maternal side effects to mothers and not seems to increase risk of congenital anomalies among newborn delivered to mothers given HCQ during pregnancy.
In conclusion, among women with a history of unexplained recurrent miscarriage, administration of HCQ during preconceptional period and the first 12 weeks gestation, compared with no treatment, did not improve the ongoing pregnancy rates at 20 weeks or live birth rates.