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Clinical trials (CT) at the international level with human participation are necessarily subject to clear and comprehensive international ethical standards in approved documents that have been in force since 1964, in order to protect the human right to health and their safety. Since then, numerous regulatory documents in the field of CT have been developed in the world, which are based on the study of previous experience in compliance, primarily with patient safety rules, and are also constantly updated to include regulatory and organizational technologies in response to the challenges of the time or requests of society. The regulatory and legal documents on the conduct of clinical trials, which are given in the review article, are directive documents for many countries, even if a country did not participate in their development, in particular for Ukraine. The participation of the World Health Organization (WHO) is highlighted in many methodological materials for the possibility of implementing directives in WHO member countries, which indicates its leading position in public health research and interest in safety control for a person participating in clinical trials and patients. WHO combines partnerships of state bodies with intergovernmental bodies and non-governmental organizations providing medical care, foundations, clinical trials sponsors, research centers and pharmaceutical companies to achieve an effective result, as well as prevent violations of ethical norms, since research is related to health and can potentially bring participants not only benefit, but also harm. The article also highlights currently unsettled issues regarding current regulatory and legal acts that do not provide detailed formalization, and the solution of many problems of clinical trials remains at the discretion of the developer. International experience in regulating clinical trials shows that none of the regulatory systems is absolutely perfect, so it is necessary to constantly monitor its effectiveness and update it. Today, information on clinical trials is available only to the Regulatory Authorities of the European Union, the European Commission and national regulatory authorities, and leading clinical trial sponsor companies publish information about their studies only on their own websites, and there is no single pan-European information resource on clinical trials. It was found that the latest approach to global clinical trial regulation works in favor of leading transnational corporations by spreading patent law, which limits the right to conduct clinical trials by medium-sized and small pharmaceutical companies. The analysis of regulatory documents on the organization and conduct of clinical trials at the international level showed that the documents need to be improved and updated taking into account the challenges of the time regarding the spread of major human diseas es. [ABSTRACT FROM AUTHOR]

The World Health Organization (WHO) defines that people in all walks of life should have a healthier lifestyle, noting that a healthy lifestyle (HLS) is one that reduces the risk of serious illness or premature death. Scientific studies have identified certain types of behavior that increase the risk of developing infectious and non-infectious diseases and early death [1]. According to the literature sources, the main modern international strategies regarding the right to HLS, observance of these rights in different countries, as well as the timeliness of the documented strategies for today's challenges regarding youth health problems are analyzed. The strategies for solving the health problems of youth and adolescents are highlighted according to their impact on the rated negative indicators of youth health, namely: problems of injuries, accidents on the water, mental health, use of alcohol, tobacco, psychoactive substances, violence, nutrition and physical inactivity, reproductive health and teenage pregnancy, infectious diseases, in particular HIV infection and tuberculosis. The presented indicators of the health of youth and adolescents are in the plane of international strategies for a healthy lifestyle. The international community of scientists is sure that rating health problems have a behavioral nature of their occurrence. In order to develop and implement the best healthy lifestyle strategies at the international, national and local levels to help adolescents and young people to be informed about harmful behavioral practices in order to prevent them and thus acquire a better and longer life. International strategies for success in solving youth health problems are characterized by systematicity, relevant and timely response to this or that problem, intersectorality, responsible communication, state support and active community participation. Bibliosemantic and analytical methods were used to study the main international strategies for the implementation of elements of a healthy lifestyle for the purpose of forming and preserving the health, quality and length of life of young people. Based on the analysis, it can be stated that the issue of forming a healthy lifestyle among teenagers and young people is a priority issue at the global level and at the national level of developed countries. International strategies on the lifestyle of young people are developed in response to the main health problems, which are monitored on an ongoing basis with detailed information to countries in various forms: generalized WHO reports and resolutions of international forums, proposals based on the results of numerous studies of the state of youth health, strategic tasks regarding the solution of youth health problems, in particular of a behavioral nature. WHO is a leader in generalizing the main problems of youth health and creating international working groups to develop unified strategies, emphasizing that the formation of the principles of a healthy lifestyle in adolescence will be a significant positive result in terms of health, quality and length of life of adults. In the international strategies, it is emphasized that measures for the formation of a healthy lifestyle among teenagers should have significant political and financial state support, an interdisciplinary nature with the participation of the community of each country, as well as a systematic implementation. The analyzed international strategies regarding the lifestyle of young people are designed to draw the attention of the countries of the world to the main health problems of young people, which, if they are not solved, are indicated throughout the life of each person, negatively affecting the quality and length of his life. International strategies which are generalized and supported by the WHO are a ready methodical tool for developing national strategies in the countries of the world, taking into account the cultural characteristics of each country. [ABSTRACT FROM AUTHOR]

Strategic documents on reproductive health (RH) determine the priority of this component of the general state of the population health in any country, as well as through separate targeted measures – the impact on demographic trends. In particular, measures to respect woman’s rights to protect her health, to exercise reproductive rights, to give birth to a healthy child in decent conditions, and to provide access to preventive and medical-diagnostic technologies. The health status of the population, especially its positive trends, in turn affects the provision of favorable demographic prospects of the country and is an important component of the formation of its demographic potential. The objective: to study the dependence of the state of the population RH in Ukraine on the influence of program strategic measures on its main indicators. Materials and methods. Bibliosemantic, analytical, statistical and conceptual methods were used during the research. The research period is 2002–2023. Results. According to the results of the conducted research on the trends in the state of RH in women in Ukraine, it was established that it has an unsatisfactory character in terms of its main indicators: against the background of positive changes sexually transmitted infections are quite common; regulation of the birth rate in the country takes place by terminating unwanted pregnancies; the unsatisfactory state of health of pregnant women affects the health and life of newborns; the negative dynamics of complicated births and their adverse consequences lead to maternal and infant losses. The social and economic situation of women in Ukraine, the unsatisfactory state of health care and the level of women’s well-being and their integration into social and political and economic life (Ukraine currently ranks 117th place among 177 countries in the world) lead to an annual decrease in the birth rate and negative demographic trends. The results of the study on the presence and impact of domestic strategies on improving the RH state showed that they have not been developed in Ukraine today, despite the recommendations of ratified international strategic documents. Moreover, the analyzed domestic strategies for influencing the RH state with sufficient state funding and political support of power structures in 1995–2015 proved their effectiveness in achieving positive trends both in terms of RH indicators and demographic processes. Conclusions. The conducted research indicates the need to develop a domestic cross-sectoral strategic document at the national level with comprehensive reproductive health protection measures and conditions for its implementation in order to improve the demographic prospects of Ukraine. [ABSTRACT FROM AUTHOR]

Epidural analgesia (EA) provides the most effective labor analgesia, however, it significantly affects the process of childbirth, so finding out the true frequency of adverse outcomes in the case of EA during vaginal birth is relevant. The objective: to establish the frequency of use of EA in maternity healthcare institutions of Ukraine, to determine the relationship between the development of adverse perinatal outcomes in women with vaginal births and use of EA, and the introduction of alternative methods of analgesia for vaginal births. Materials and methods. The frequency of adverse outcomes was analyzed in the group of women who had a vaginal birth and who did not use EA (n=27 503) and in the group of women who had a vaginal birth with EA (n=22 214). The frequency of EA use in vaginal births in 2023 was studied during premature births at 22–25 weeks of pregnancy, 26–32 weeks and 32–37 weeks, pregnancies with preeclampsia, diabetes, breech presentation of the fetus, and the presence of a uterine scar. The data of the medical records of the electronic health care system of women who had vaginal births during 2023 served as the information base. Bibliosemantic, analytical, epidemiological, statistical and conceptual research methods were used. Results. The use of EA is a common method of analgesia for childbirth in Ukraine. EA during childbirth significantly increases the chances of a woman having a prolonged labor (odds ratio (OR) 4.71; p<0.001), weakness of labor (OR 3.52; p<0.001), stimulation of labor (OR 2.36; p< 0.001), instrumental vaginal births (OR 2.76; p<0.001), rupture of the perineum of the 2nd degree (OR 1.24; p<0.001), cervical rupture (OR 1.15; p=0.011), vaginal rupture (OR 1.17; p<0.001), episiotomy (OR 1.71; p<0.001), delayed separation of the placenta (OR 1.32; p<0.001) and fetal distress (OR 1.8; p<0.001). An alternative to EA can be effective non-pharmacological pain management (NРPM), which has numerous advantages in terms of the absence of complications. Effective implementation of NPPM in practice requires the development of a comprehensive approach, including improved education and support for women, availability of resources, and promotion of dissemination of knowledge about NPPM among health care providers. Conclusions. In the study, reliable results were obtained regarding a higher frequency of adverse outcomes in women who received EA compared to women who did not receive EA, namely: prolonged labor, weakness of labor, stimulation of labor, instrumental vaginal delivery, second-degree perineal rupture, cervical rupture, vaginal rupture, episiotomy, delayed separation of the placenta, and fetal distress. These results indicate the need for a balanced approach to the use of EA, based on the benefits and risks for the woman and the fetus. The use of NPPM is a promising alternative that potentially improves the birth experience, reduces adverse effects, and improves outcomes for both mothers and newborns. These methods use the natural pain-relief mechanisms of the organism and promote relaxation, comfort, reduced anxiety, and increased labor satisfaction. In addition, their use has a minimal number of side effects and risks, which makes them an attractive option for most women. [ABSTRACT FROM AUTHOR]

According to global data the prevalence of endometriosis ranges from 2 to 10% among the general female population and up to 50% among women with infertility. Therefore, at least 190 million women and adolescent girls worldwide have been diagnosed with this disease. Endometriosis, according to evidence, can exhaust a woman physically and emotionally, thereby significantly reducing her quality of life. In particular, pain symptoms affect quality of life and a range of activities and life domains, including physical functioning, daily activities and social life, education and work, sex, intimate relationships and intimate partnerships, and mental health and emotional well-being. This pathology is often accompanied by infertility. Endometriosis has social importance in general, for example due to direct and indirect health care costs comparable to other common diseases such as type 2 diabetes, rheumatoid arthritis and Crohn’s disease. The pathogenesis of endometriosis prompts scientists to search for new methods of conservative treatment. One of the modern means that allow to expand the clinical possibilities of impact on endometriosis is a drug from the dienogest group. The commitment of specialists to the use of dienogest is significantly influenced by the understanding of its pharmacokinetics. After oral use, dienogest is quickly and completely absorbed. The maximum concentration in blood serum is reached within 1.5 hours after a single oral intake and is 47 ng/ml. The bioavailability of dienogest is quite high and is approximately 91%. Its pharmacokinetics are dose-dependent in the dose range of 1–8 mg. Dienogest at a dose of 2 mg/day is an effective alternative to surgery for the long-term treatment of endometriosis, which is well tolerated and has a number of important advantages over combined oral contraceptives. In addition, the available data indicate that patients are ready for possible irregular bleeding, which often occurs with the use of 2 mg of dienogest, since the drug reduces the painful manifestations of endometriosis. In clinical practice, important components of treatment management are counseling patients about expected side effects, evaluating the effectiveness and safety of each therapeutic approach, and following existing recommendations regarding the provision of individual care in accordance with the needs and wishes of each woman. Therefore, dienogest belongs to the standard of treatment of endometriosis, it is included in national and world clinical protocols as a drug of the first line of its treatment. [ABSTRACT FROM AUTHOR]

This article is a review of current scientific publications that are devoted to the problem of sexually transmitted infections (STIs) and the importance of probiotics in their treatment. The article also analyzes the data of regulatory documents of the World Health Organization and statistical data of the Center for Medical Statistics of the Ministry of Health of Ukraine and the State Statistics Service of Ukraine, which highlight the problem of the prevalence of STIs in the world and in Ukraine. Sexually transmitted infections have a serious negative impact on sexual and reproductive health worldwide. In the absence of treatment, they can have serious outcomes, including neurological and cardiovascular diseases, infertility, ectopic pregnancy, increased risk of infection with the human immunodeficiency virus. One of the serious factors which prevent the reduction of STDs increased rate in the world is the drug resistance for these infections. Infections caused by resistant strains of microorganisms are characterized by a more severe course, more often require hospitalization of the patient, increase the duration of the patient’s stay in the hospital, require the use of combined antibiotic therapy with the administration of reserve drugs. According to the results of scientific studies, Bacillus probiotics are an alternative for solving problems related to STIs and their outcomes. The innovative combination of the components of the drugs that contain the SirionProbioProtection probiotic formula helps to overcome such a problem as the resistance of STI pathogens to etiotropic antibiotic therapy. The use of alternative methods of exposure to STIs and their consequences add to success in providing obstetric and gynecological services. [ABSTRACT FROM AUTHOR]

The maternal mortality (MM) rate is considered an integrated indicator of women’s reproductive health, which reflects not only the state of general health, including reproductive one, the quality of medical care for pregnant women and the level of organizational work of maternity institutions, but also the combined interaction of these factors with economic, ecological, sanitary-cultural, social-hygienic and other ones. The objective: to highlight the current problem of MM in Ukraine and the world, finding its main factors and ways to solve it. Materials and methods. Bibliosemantic, analytical, statistical and conceptual methods were used. The research period is 2010–2022. Results. The MM rate is currently an extreme problem worldwide. The World Health Organization (WHO) emphasizes that MM is unacceptably high. In 2020, almost 287,000 women died during and after pregnancy and childbirth. Almost 95% of all maternal deaths in 2020 occurred in low-income and lower-middle-income countries, and most of them were preventable. Conclusions. In Ukraine, there is a negative wave-like situation with the MM indicator, that is fluctuations from decrease to increase. And even the decrease in the MM indicator does not reach its level in developed countries. In 2022, 19.3 per 100,000 live births were registered. The main reasons for the high rates of MM in Ukraine are: the imperfection of the health care system in relation to the formation of reproductive health in adolescents, the loss of the potential of the family planning system, the insufficient level of accessibility of Ukrainian women to reproductive health care services, the low level of organization of perinatal assistance and its effectiveness, lack of a monitoring system for compliance with quality criteria of clinical protocols, as well as an insufficient level of socio-economic support of the population. The implementation of measures of the WHO Global Strategy and goals for the prevention of maternal mortality by 2030 will contribute to the reduction of the MM indicator, namely, the increase in the availability and quality of medical and sanitary services in the health care system of adolescents, mothers and newborns, in reproductive health, for the prevention of maternal mortality, improving the efficiency of the health care system. [ABSTRACT FROM AUTHOR]

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