Ukrainian Journal Health of Woman. 2025. 5(180): 40-46. doi: 10.15574/HW.2025.5(180).4046
Frolov S. V., Golyanovskiy О. V.
Shupyk National Healthcare University of Ukraine, Kyiv

For citation: Frolov SV, Golyanovskiy ОV. (2025). The combination of cognitive-behavioral therapy and pharmacological correction of sleep disorders as the most effective approach to preventing perinatal complications in pregnant women. Ukrainian Journal Health of Woman. 5(180): 40-46. doi: 10.15574/HW.2025.5(180).4046
Article received: Jun 39, 2025. Accepted for publication: Oct 30, 2025.

Aim – to assess the effectiveness of different approaches to the correction of sleep disorders in pregnant women from the perspective of their impact on sleep quality and the incidence of perinatal complications.
Materials and methods. A randomized clinical trial was conducted with the participation of 245 pregnant women from October 2022 to December 2024. Group I – 175 pregnant women with sleep disorders, and group II – 70 pregnant women without sleep disorders were formed by simple randomization. Group I was divided into three subgroups by blind randomization: Ia (n=49) – cognitive behavioral therapy (CBT) for 10 weeks using the Sleepio for Pregnancy electronic application; Іb (n=55) – complex therapy (psychoeducation on sleep hygiene, vitamin-mineral complex, micronized progesterone); Іc (n=71) – a combination of CBT and complex therapy. Verification of sleep disorders was carried out using an adapted version of the Pittsburgh Sleep Quality Index for Pregnancy (PSQI-P), the Insomnia Severity Index (ISI) and the Epworth Sleepiness Scale (ESS). The examinations were carried out in the II-III trimesters (22-41 weeks). The primary and secondary endpoints included the frequency of threatened preterm birth, hypertensive disorders, gestational diabetes, cesarean section, low birth weight and postpartum hemorrhage. Statistical analysis was performed using the Student's t-test.
Results. Before treatment, no significant differences were found between subgroups Іa and Іc in the frequency of perinatal complications, while they were significantly different from group II. After therapy, a significant decrease in the frequency of threatened preterm birth, hypertensive disorders, cesarean section and low fetal weight was recorded in subgroup Ic, as well as a significant improvement in PSQI-P, ISI and ESS indicators. The difference between subgroup Ic and the group II became statistically insignificant.
Conclusions. Combining CBT and complex pharmacotherapy is the most effective approach to correcting sleep disorders in pregnant women, reducing the frequency of perinatal complications to the level of healthy pregnant women.
The study was performed in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the local ethics committee of the institution indicated in the work. Informed consent of the women was obtained for the study.
The authors declare no conflict of interest.
Keywords: pregnancy, sleep disorders, cognitive-behavioral therapy, progesterone, perinatal complications, prevention, sleep quality, PSQI.

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