跳至主要内容
临床试验/NCT07551934
NCT07551934招募中不适用

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

Taras Shevchenko National University of Kyiv2 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2026年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
328
试验地点
2
主要终点
World Health Organization - Five Well-Being Index, WHO-5

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Partners

Partners of enrolled women who provide informed consent and participate in the study as a supplementary dyadic subgroup.

干预措施: Psychological Assessment (Diagnostic Test)

Postpartum women

Women who have given birth and are within 12 months postpartum at the time of enrolment.

干预措施: Psychological Assessment (Diagnostic Test)

Non-pregnant women

Women who are not pregnant at the time of enrollment and who either report an intention to become pregnant or report that they are not currently planning pregnancy.

干预措施: Routine Clinical Data Collection (Diagnostic Test)

Non-pregnant women

Women who are not pregnant at the time of enrollment and who either report an intention to become pregnant or report that they are not currently planning pregnancy.

干预措施: Psychological Assessment (Diagnostic Test)

Pregnant women

Women with an ongoing pregnancy at the time of enrolment, regardless of gestational age.

干预措施: Routine Clinical Data Collection (Diagnostic Test)

Postpartum women

Women who have given birth and are within 12 months postpartum at the time of enrolment.

干预措施: Routine Clinical Data Collection (Diagnostic Test)

Pregnant women

Women with an ongoing pregnancy at the time of enrolment, regardless of gestational age.

干预措施: Psychological Assessment (Diagnostic Test)

结局指标

主要结局

World Health Organization - Five Well-Being Index, WHO-5

时间窗: Baseline, 3 months, 6 months, and 12 months after enrolment

World Health Organization - Five Well-Being Index

时间窗: Baseline, 3 months, 6 months, and 12 months after enrolment.

Subjective well-being will be measured using the World Health Organization-Five Well-Being Index (World Health Organization, 1998). The total score ranges from 0 to 100, with higher scores reflecting higher levels of well-being. A score of 50 or below will be used as the cut-off for clinically significant decrease in well-being, in accordance with Topp et al. (2015). This measure applies to all study cohorts.

次要结局

  • Assessment, Care, and Trust in Pregnant and New Mothers, ACT-PNM(Baseline, 3 months, 6 months, and 12 months after enrolment)
  • Edinburgh Postnatal Depression Scale, EPDS(Baseline, 3 months, 6 months, and 12 months after enrolment)
  • The City Birth Trauma Scale, City BiTS(Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable)
  • The City Birth Trauma Scale Partner Version, City BiTS Partner Version(Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable)
  • Desire to Avoid Pregnancy Scale, DAP(Baseline, 3 months, 6 months, and 12 months after enrolment)
  • Suicide Crisis Inventory-2 Short Form, SCI-2-SF(Baseline and follow-up assessments up to 12 months after enrolment)
  • London Measure of Unplanned Pregnancy, LMUP(Baseline, 3 months, and 12 months after enrolment, where applicable)
  • Swedish Pregnancy Planning Scale, SPPS(Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable)
  • The Birth Satisfaction Scale-Revised, BSS-R(Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable)
  • Domestic Violence Myth Acceptance Scale, DVMAS(Baseline and follow-up assessments up to 12 months after enrolment)
  • General Anxiety Disorder-7, GAD-7(Baseline and follow-up assessments up to 12 months after enrolment)
  • Impact of Events Scale-Revised, IES-R(Baseline and follow-up assessments up to 12 months after enrolment)
  • Edinburgh Postnatal Depression Scale(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • The City Birth Trauma Scale(Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.)
  • The City Birth Trauma Scale (Partner version)(Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.)
  • The Birth Satisfaction Scale - Revised(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • Desire to Avoid Pregnancy Scale(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • London Measure of Unplanned Pregnancy(Baseline, 3 months, and 12 months after enrolment.)
  • Maternal and Partner Sex During Pregnancy Scales(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • Motivations Against Sex Questionnaire(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • Domestic Violence Myth Acceptance Scale(Baseline and 12 months after enrolment.)
  • General Anxiety Disorder - 7(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • Impact of Events Scale - Revised(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • Suicide Crisis Inventory - 2 Short Form(Baseline, 3 months, 6 months, and 12 months after enrolment.)
  • Adverse Childhood Experiences Questionnaire(Baseline, 3 months, 6 months, and 12 months after enrolment.)

研究者

发起方
Taras Shevchenko National University of Kyiv
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazar Yatsenko

Asst Prof

Taras Shevchenko National University of Kyiv

研究点 (2)

Loading locations...

相似试验