Лечение и профилактика самопроизвольного выкидыша в условиях реальной клинической практики. Проспективное мультицентровое исследование

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Objective. To evaluate the efficacy and safety of micronized progesterone as part of the most common treatment regimens for preventing miscarriage, as well as patient satisfaction and adherence; to examine the overall clinical response to therapy and to determine the rate of pregnancy prolongation until fetal viability is reached based on physician assessments. Patients and methods. Data were collected from a sample of 300 patients in their first trimester of pregnancy who were admitted to hospital for inpatient treatment (with bleeding and/or pain) and to whom as part of pharmacotherapy regimens Prajisan® was prescribed at a daily dose of 400 mg (200 mg twice daily, intravaginal route; as indicated and according to instructions for medical use). All the procedures performed were routine, which defined the non-interventional nature of this study. Patient medical records and characteristics of their current pregnancy, including the use of medications, the presence of complications, length of stay, and adverse events that occurred during the entire period of observation and treatment, were assessed. Moreover, the survey contained additional, specially designed questionnaires to assess the patient’s condition in dynamics, the physician’s satisfaction with the therapeutic effect, and the patient’s satisfaction with the treatment used (Likert scale). The primary endpoint was the prolongation of pregnancy until hospital discharge; the secondary endpoint was the prolongation of pregnancy until potential fetal viability (up to 22 weeks and 0 days). Mathematical and statistical data processing was performed using standard software packages Statistica (v7.0) and SPSS Statistics (v23.0). Results. The efficacy of combination therapy (achievement of the primary endpoint), which included micronized progesterone (Prajisan® 200 mg intravaginally twice daily), was 96.84%. The therapy was not associated with adverse events in 100% of cases. Physician and patient satisfaction with the convenience of use (according to the mean Likert score) did not differ significantly and was 4.21 ± 0.7 and 4.07 ± 0.8, respectively. Physician satisfaction with the clinical response to treatment was significantly higher than patient satisfaction with the convenience of use (mean Likert score was 4.39 ± 0.5 and 4.07 ± 0.8, respectively). The secondary endpoint was reached in 100% of the patients discharged from hospital with progression of pregnancy. No adverse events were recorded. Conclusion. The findings of this prospective multicenter study obtained in different medical institutions in nine major cities of Russia (including megacities) allow us to conclude about the positive experience with the use of Prajisan® and to recommend it for pregnancy prolongation in the routine practice of Russian obstetricians and gynecologists. Key words: early pregnancy loss, miscarriage, risk factors, prevention, micronized progesterone