The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an active comparator. The hypothesis is based on the evidence found in vitro and in vivo experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of miscarriage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
Patients will receive oral CsA in a dose of 50mg three times a day for 20-30 days since the occurrence of positive result in human chorionic gonadotropin (HCG) test in urine and 14 consecutive days of elevated basal body temperature. The dosage of CsA will be adjusted according to baseline and peak value of CsA blood concentration. If the baseline blood concentration of CsA is lower than 40ng/ml or the peak blood concentration of CsA is lower than 500ng/ml, the dosage of CsA will be increased to 75 mg three times a day.
Patients will receive oral dydrogesterone 10 mg three times a day for 30 days since the occurrence of positive result in HCG test in urine and 14 consecutive days of elevated basal body temperature.
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, China
Live birth rate
The difference in the live birth rates between patients with recurrent miscarriage assigned oral CsA and Dydrogesterone.
Time frame: Up to 36 months
The difference in the rate of miscarriage between patients with recurrent miscarriage treated with CsA and Dydrogesterone.
The difference in the rates of miscarriage (pregnancy loss before 20 weeks gestation) between patients assigned oral CsA and Dydrogesterone.
Time frame: Up to 36 months
Fetal death
The difference in the rates of fetal death (fetal death after 20 weeks of gestational age) between patients assigned oral CsA and Dydrogesterone.
Time frame: Up to 36 months
The difference in the rate of premature delivery between patients treated with CsA and Dydrogesterone.
The difference in the rates of premature delivery (deliveries with gestational age less than 37 weeks) between patients assigned oral CsA and Dydrogesterone.
Time frame: Up to 36 months
Congenital malformations
The difference in the rates of congenital malformations between patients assigned oral CsA and Dydrogesterone.
Time frame: Up to 36 months
Maternal outcomes: morbidity of infectious disease
The difference of morbidity of infectious disease in pregnancy between two arms.
Time frame: Up to 36 months
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