- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551934
Women's Reproductive Choices and Mental Health During Pregnancy and After Birth in Wartime Ukraine
Integrative Model of Factors Influencing Reproductive Behavior and Perinatal Mental Health of Women Amidst War
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nazar Yatsenko, MSc
- Phone Number: +380733700423
- Email: nazaryatsenko@knu.ua
Study Locations
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Kyiv, Ukraine
- Taras Shevchenko National University of Kyiv
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Contact:
- Nazar Yatsenko, MSc
- Phone Number: +380733700423
- Email: nazaryatsenko@knu.ua
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Principal Investigator:
- Liudmyla Krupelnytska, DSc
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Sub-Investigator:
- Volodymyr Artyomenko, DSc
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Sub-Investigator:
- Olha Morozova-Larina, PhD
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Sub-Investigator:
- Antonina Molotokas, PhD
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Sub-Investigator:
- Alona Vavilova, PhD
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Sub-Investigator:
- Stanislav Kazakov, PhD
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Sub-Investigator:
- Artem Baratiuk, MSc
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Sub-Investigator:
- Nazar Yatsenko, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- able and willing to provide informed consent;
- aged 18 years or older.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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.
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Pregnant women
Women with an ongoing pregnancy at the time of enrolment, regardless of gestational age.
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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.
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.
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Postpartum women
Women who have given birth and are within 12 months postpartum at the time of enrolment.
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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.
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.
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Partners
Partners of enrolled women who provide informed consent and participate in the study as a supplementary dyadic subgroup.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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World Health Organization - Five Well-Being Index
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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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.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Edinburgh Postnatal Depression Scale
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale (Cox et al., 1987).
The total score ranges from 0 to 30, with higher scores reflecting greater severity of depressive symptoms.
A score of 13 or above will be used as the cut-off for clinically significant depressive symptoms, in accordance with Cox et al. (1987) and Levis et al. (2020).
This measure applies to pregnant and postpartum women.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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The City Birth Trauma Scale
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
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Childbirth-related post-traumatic stress symptoms will be measured using the City Birth Trauma Scale (Ayers et al., 2018).
The symptom score ranges from 0 to 60, with higher scores reflecting greater severity of childbirth-related post-traumatic stress symptoms.
A score of 29 or above will be used as the cut-off for clinically significant symptoms, in accordance with Osório et al. (2020).
This measure applies to postpartum women.
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Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
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The City Birth Trauma Scale (Partner version)
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
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Childbirth-related post-traumatic stress symptoms among partners will be measured using the City Birth Trauma Scale, Partner Version (Webb et al., 2019).
The symptom score ranges from 0 to 60, with higher scores reflecting greater severity of childbirth-related post-traumatic stress symptoms.
No predefined cut-off score will be applied.
This measure applies to participating partners.
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Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
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The Birth Satisfaction Scale - Revised
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Satisfaction with the childbirth experience will be assessed using the Birth Satisfaction Scale - Revised (Martin & Martin, 2014).
The total score ranges from 0 to 40, with higher scores reflecting greater satisfaction with childbirth.
No predefined cut-off score will be applied.
This measure applies to postpartum women.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Desire to Avoid Pregnancy Scale
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Attitudes toward pregnancy avoidance will be measured using the Desire to Avoid Pregnancy Scale (Rocca et al., 2019).
The total score ranges from 0 to 4, with higher scores reflecting a stronger desire to avoid pregnancy.
A cut-point below 2 will be used for pregnancy prediction, in accordance with Hall et al. (2023).
This measure applies to non-pregnant women.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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London Measure of Unplanned Pregnancy
Time Frame: Baseline, 3 months, and 12 months after enrolment.
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Pregnancy intention will be measured using the London Measure of Unplanned Pregnancy (Barrett et al., 2004).
The total score ranges from 0 to 12, with higher scores reflecting greater pregnancy intention.
No predefined cut-off score will be applied.
This measure applies to pregnant and postpartum women.
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Baseline, 3 months, and 12 months after enrolment.
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Maternal and Partner Sex During Pregnancy Scales
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Pregnancy-related sexual attitudes will be measured using the Maternal and Partner Sex During Pregnancy Scales (Jawed-Wessel et al., 2016).
The global attitude score ranges from 1 to 6, with higher scores reflecting more positive attitudes toward sex during pregnancy.
No predefined cut-off score will be applied.
This measure applies to pregnant women and their partners.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Motivations Against Sex Questionnaire
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Motivations for sexual avoidance will be measured using the Motivations Against Sex Questionnaire (Patrick et al., 2011).
Subscale mean scores range from 1 to 5, with higher scores reflecting stronger endorsement of the respective motivation for not engaging in sexual behavior.
No predefined cut-off score will be applied.
This measure applies to all study cohorts.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Domestic Violence Myth Acceptance Scale
Time Frame: Baseline and 12 months after enrolment.
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Attitudes toward domestic violence will be measured using the Domestic Violence Myth Acceptance Scale (Peters et al., 2008).
The total mean score ranges from 1 to 7, with higher scores reflecting stronger endorsement of domestic violence myths.
No predefined cut-off score will be applied.
This measure applies to all study cohorts.
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Baseline and 12 months after enrolment.
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General Anxiety Disorder - 7
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Anxiety symptoms will be measured using the Generalized Anxiety Disorder - 7 (Spitzer et al., 2006).
The total score ranges from 0 to 21, with higher scores reflecting greater anxiety symptom severity.
A score of 7 or above will be used as the cut-off for clinically significant anxiety symptoms in the perinatal population, according to Gong et al. (2021) and Zhong et al. (2015); a score of 10 or above will be used for partners (Spitzer et al., 2006).
This measure applies to all study cohorts.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Impact of Events Scale - Revised
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Trauma-related distress will be measured using the Impact of Event Scale-Revised (Weiss & Marmar, 1997).
The total score ranges from 0 to 88, with higher scores reflecting greater severity of trauma-related symptoms.
A score of 30 or above will be used to indicate a high probability of trauma-related disorder (Krupelnytska et al., 2025).
This measure applies to all study cohorts.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Suicide Crisis Inventory - 2 Short Form
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Suicidal crisis symptoms will be measured using the Suicide Crisis Inventory - 2 Short Form (De Luca et al., 2024).
The total score ranges from 0 to 36, with higher scores reflecting greater severity of suicide crisis syndrome.
No predefined cut-off score will be applied.
This measure applies to all study cohorts.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Adverse Childhood Experiences Questionnaire
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Exposure to childhood adversity will be measured using the Adverse Childhood Experiences Questionnaire (Felitti et al., 1998).
The cumulative score ranges from 0 to 10, with higher scores reflecting exposure to a greater number of adverse childhood experiences before age 18.
This measure applies to all study cohorts.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment, Care, and Trust in Pregnant and New Mothers
Time Frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
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Demographic, reproductive, background, and war-related information will be collected using the Assessment, Care, and Trust in Pregnant and New Mothers questionnaire, developed by Rodríguez-Muñoz et al. (2023) for use in a Ukrainian sample.
The questionnaire was adapted for use across all study cohorts, including partners and non-pregnant women.
This measure is not scored as a scale; therefore, no minimum or maximum total score or better/worse score direction applies.
Item-level data will be used to describe the sample and as potential covariates in further analyses.
This measure applies to all study cohorts.
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Baseline, 3 months, 6 months, and 12 months after enrolment.
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Collaborators and Investigators
Investigators
- Study Director: Liudmyla Krupelnytska, DSc, Taras Shevchenko National University of Kyiv
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Urogenital Diseases
- Mental Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Mood Disorders
- Puerperal Disorders
- Stress Disorders, Traumatic
- Depressive Disorder
- Behavior
- Personal Satisfaction
- Psychological Trauma
- Depression, Postpartum
- Stress Disorders, Post-Traumatic
- Psychological Well-Being
- Reproductive Behavior
Other Study ID Numbers
- 26ГФ016-01
- 2025.07/0191 (Other Grant/Funding Number: The National Research Foundation of Ukraine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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