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Набор скоро начнётся NCT07551934

Women's Reproductive Choices and Mental Health During Pregnancy and After Birth in Wartime Ukraine

— Наблюдательное Perinatal Mental Health Reproductive Behavior Women Cohort Studies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psychological Assessment, Routine Clinical Data Collection.
Кому может быть актуально
Состояния в реестре: Perinatal Mental Health, Reproductive Behavior, Women, Cohort Studies. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Украина
Следующий шаг
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Официальное название

Integrative Model of Factors Influencing Reproductive Behavior and Perinatal Mental Health of Women Amidst War

Обзор

The goal of this observational study is to learn how war affects reproductive decisions and perinatal mental health in Ukrainian women. The main questions it aims to answer are: (1) how are wartime stress and trauma related to women's decisions about pregnancy and childbirth?; (2) what mental health symptoms and psychological difficulties are experienced during the perinatal period under wartime conditions? (3) which demographic, obstetric, and psychological factors are linked to poorer mental health and childbirth experiences? Researchers will survey at least 300 women. Participants will: (1) complete questionnaires about their mental health and psychological well-being; (2) answer questions about their reproductive choices, pregnancy, and/or childbirth experiences; (3) report on the impact of war, social support, maternal care, and postpartum trauma; (4) provide demographic and obstetric information. The findings will be used to develop an evidence-based model of the factors influencing reproductive behavior and perinatal mental health during war.

Вмешательства

  • Диагностический тест Psychological Assessment
    A participant-completed questionnaire administered to eligible women and, where applicable, to partners included in the supplementary dyadic component. Question flow will be adapted through programmed routing logic so that participants are presented only with items relevant to their reproductive stage and experiences.
  • Диагностический тест Routine Clinical Data Collection
    Clinical data abstracted from routine medical records, including maternal, obstetric, fetal, delivery, and neonatal indicators relevant to the study. Data collection will be limited to information available in routine care and recorded only with participant consent.

Первичные конечные точки

  • World Health Organization - Five Well-Being Index [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
Вторичные конечные точки (12)
  • Edinburgh Postnatal Depression Scale [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • The City Birth Trauma Scale [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.]
  • The City Birth Trauma Scale (Partner version) [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.]
  • The Birth Satisfaction Scale - Revised [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • Desire to Avoid Pregnancy Scale [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • London Measure of Unplanned Pregnancy [Срок оценки: Baseline, 3 months, and 12 months after enrolment.]
  • Maternal and Partner Sex During Pregnancy Scales [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • Motivations Against Sex Questionnaire [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • Domestic Violence Myth Acceptance Scale [Срок оценки: Baseline and 12 months after enrolment.]
  • General Anxiety Disorder - 7 [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • Impact of Events Scale - Revised [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]
  • Suicide Crisis Inventory - 2 Short Form [Срок оценки: Baseline, 3 months, 6 months, and 12 months after enrolment.]

Критерии участия

Критерии включения

  • able and willing to provide informed consent;
  • aged 18 years or older.

Критерии исключения

  • younger than 18 years;
  • unable to provide informed consent;
  • do not have sufficient language proficiency to complete the study procedures;
  • at the time of recruitment, they have an acute medical or psychological condition that would make participation unsafe, inappropriate, or unduly burdensome (e.g., obstetric emergencies, immediate postoperative or critical care status, or severe acute distress requiring urgent clinical care);
  • participation or the handling of personal data could reasonably pose a risk to the safety of the participant or their family.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Украина · 1 центр
  • Taras Shevchenko National University of Kyiv — Kyiv

Публикации

  • Krupelnytska L, Yatsenko N, Molotokas A, Morozova-Larina O, Vavilova A, Baratiuk A, Kazakov S, Artyomenko V. Perinatal mental health and reproductive behavior among women in wartime Ukraine: a cohort study protocol. Front Psychiatry. 2026 Jul 6;17:1874060. doi: 10.3389/fpsyt.2026.1874060. eCollection 2026. PMID 42519206

Идентификаторы

NCT: NCT07551934 · 26ГФ016-01 · 2025.07/0191

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗