Treatment options and pregnancy outcome in women with idiopathic recurrent miscarriage: a randomized placebo-controlled study (Publication with Expression of Concern. See AUG, 2023)

Objective To compare the use of enoxaparin alone with combination therapy of prednisone, aspirin and progesterone in the treatment of women with idiopathic recurrent miscarriage (IRM) in terms of live births and pregnancy outcome. Methods A prospective, randomized, single-blinded, placebo-controlled trial was conducted at a tertiary referral obstetric hospital. The participants were 170 women with a diagnosis of IRM. Women were recruited after full investigative screening. Women with >= 3 fetal losses and after exclusion of all known causes of recurrent miscarriage were randomly allocated to receive either enoxaparin alone, combination treatment consisting of prednisone, aspirin, and progesterone or placebo. Rates of live births, antenatal complications, delivery and neonatal outcomes were recorded prospectively. Data were statistically analyzed as appropriate. Results Ten patients were dropped out after random assignment. Eighty-one percent of the enoxaparin (46/57) group and 85% of the combination-treated group (45/53) were delivered of live infants compared to 48% (24/50) of the placebo (P < 0.05). Women who were treated with combination therapy had a 4.2% higher live birth rate than enoxaparin group. This difference was not significant. Miscarriage rates were significantly lower in the treated groups compared with placebo (P < 0.05). There were no significant differences in late obstetric complications or neonatal mortality between groups. Conclusions A combination treatment consisting of high-dose, low-duration prednisone, progesterone and aspirin might be an effective treatment as enoxaparin alone. Both regimens were associated with a good pregnancy outcome.