OUTCOMES OF THE SECOND HALF OF PREGNANCY IN PATIENTS WITH RECURRENT PREGNANCY LOSS (RESULTS OF MULTICENTER STUDY OF TRISTAN-2)


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Objective. To assess obstetric and neonatal outcomes of the second half of pregnancy (after 22 weeks) in women with a habitual miscarriage who received or did not receive periconceptional care and therapy with micronized progesterone (a pharmaceutical product of Utrogestan) in the framework of TRISTAN-2 multicenter study. Materials and methods. A total of 743 women who are 22-24 weeks pregnant and diagnosed with habitual miscarriage (2 or more consecutive interruptions of pregnancy in anamnesis) took part in the study. All patients included in TRISTAN-2 study, previously participated in TRISTAN-1 study (TRISTAN-2 study is a continuation of TRISTAN-1 patients’ observation). Of these, 369patients in Group 1 received periconceptional care with micronized progesterone before conception in the luteal phase of their menstrual cycle and during the first half of pregnancy (intravaginally 200-400 mg / day), 374 patients in Group 2 started taking micronized progesterone only after the clinical confirmation of pregnancy and during the first half of pregnancy (intravaginally 200-400 mg / day). All patients underwent micronized progesterone therapy in the second half of pregnancy (intravaginally 200-400 mg / day) with the appropriate indications described in the instructions for the medical use of Utrogestan). The monitoring of patients in both groups was carried out in late pregnancy (starting from 22 weeks 0 days before discharge from the hospital after delivery). The study collected data on the course of the current pregnancy and its outcomes: gestational age at the time of delivery, neonatal outcomes, use of additional medications, complications and hospitalizations during pregnancy, adverse events on the part of the mother and/or fetus/child during the whole period of observation. All medical procedures performed as part of the study were routine and used in everyday clinical practice. Statistical analysis of the collected data was carried out using IBM SPSS 23 software. Results. The main criterion for the therapy effectiveness was the frequency of preterm delivery before 34 full weeks of pregnancy. In Group 1 (patients who underwent periconceptional therapy with micronized progesterone), the incidence of preterm delivery was 8.9% (2.0% of preterm deliveries in the period of 433+6 weeks), in Group 2 (patients who started taking micronized progesterone only after the clinical confirmation of pregnancy) the incidence was 9.6% (1.7% of preterm deliveries in the period of 433+6 weeks) p> 0,05, which corresponds to the general population level in the world. Very early (before 28 weeks) and early (28-30+6 weeks) premature births in the groups were not observed. On this basis, it can be concluded that the use of micronized progesterone in accordance with approved indications is an effective tool for the prevention of preterm delivery in patients at risk of a habitual miscarriage, regardless of previous periconceptional therapy. The frequency and nature of adverse events were statistically comparable in the groups (p> 0.05). Conclusion. The presented results of the study prove the efficacy and safety of the use of micronized progesterone (the pharmaceutical product of Utrogestan) in accordance with the recorded indications in late pregnancy with a habitual miscarriage.

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