Perinatal Mental HealthNCT07551934
Women's Reproductive Choices and Mental Health During Pregnancy and After Birth in Wartime Ukraine
An observational study of Perinatal Mental Health and Reproductive Behavior, run by Taras Shevchenko National University of Kyiv at 1 site in Ukraine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perinatal Mental Health, Reproductive Behavior, Women
- What is being tested?
- Psychological Assessment and Routine Clinical Data Collection
- How many people
- 328 participants
- Where
- 1 siteUkraine
- Study dates
- 7 Jul 2026to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women will be recruited in Ukraine from healthcare settings providing reproductive, gynecological, pregnancy-planning, antenatal, childbirth, and postpartum care. The source population includes women across the reproductive continuum, including those not currently planning pregnancy, those planning pregnancy, those with an ongoing pregnancy, and those within 12 months after childbirth. Where feasible, consenting partners of enrolled women will also be included.
Who may be able to join
- able and willing to provide informed consent;
- aged 18 years or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
Taras Shevchenko National University of Kyiv
Kyiv
Nazar Yatsenko, MSc, +380733700423, nazaryatsenko@knu.ua
Liudmyla Krupelnytska, DSc
About this study
Official title: 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?
Read more
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.
- Conditions
- Perinatal Mental Health, Reproductive Behavior, Women, Cohort Studies
- Being tested
- Psychological Assessment, Routine Clinical Data Collection
- Keywords
- perinatal psychology, mental health, reproductive behavior, psychological trauma, PTSD, CB-PTSD, postpartum depression, pregnancy, sexual health, Ukraine, war-affected population
- Medical subject headings
- Reproductive Behavior, Psychological Well-Being, Psychological Trauma, Stress Disorders, Post-Traumatic, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological AssessmentDiagnostic test
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.
Routine Clinical Data CollectionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Psychological Assessment; Diagnostic Test: Routine Clinical Data Collection | |
| Pregnant women | Women with an ongoing pregnancy at the time of enrolment, regardless of gestational age. Receives: Diagnostic Test: Psychological Assessment; Diagnostic Test: Routine Clinical Data Collection | |
| Postpartum women | Women who have given birth and are within 12 months postpartum at the time of enrolment. Receives: Diagnostic Test: Psychological Assessment; Diagnostic Test: Routine Clinical Data Collection | |
| Partners | Partners of enrolled women who provide informed consent and participate in the study as a supplementary dyadic subgroup. Receives: Diagnostic Test: Psychological Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization - Five Well-Being Index
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Secondary outcomes (13)
Edinburgh Postnatal Depression Scale
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
The City Birth Trauma Scale
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
The City Birth Trauma Scale (Partner version)
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
The Birth Satisfaction Scale - Revised
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Desire to Avoid Pregnancy Scale
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
London Measure of Unplanned Pregnancy
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.
Measured: Baseline, 3 months, and 12 months after enrolment.
Maternal and Partner Sex During Pregnancy Scales
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Motivations Against Sex Questionnaire
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Domestic Violence Myth Acceptance Scale
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.
Measured: Baseline and 12 months after enrolment.
General Anxiety Disorder - 7
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Impact of Events Scale - Revised
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Suicide Crisis Inventory - 2 Short Form
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Adverse Childhood Experiences Questionnaire
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.
Measured: Baseline, 3 months, 6 months, and 12 months after enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start7 Jul 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taras Shevchenko National University of Kyiv
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazar Yatsenko, Taras Shevchenko National University of Kyiv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551934
- Sponsor's protocol ID
- 26ГФ016-01
- Other IDs
- 2025.07/0191
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications from this study will be made available. Shared data may include questionnaire-derived variables, selected longitudinal outcome measures, and other study variables contained in the final anonymized analytic dataset. Direct identifiers will not be shared. Variables that could create a meaningful risk of re-identification, including information used for follow-up administration or dyadic linkage, will be removed, aggregated, or otherwise protected before data sharing. Data shared with external researchers will be limited to the minimum necessary for the approved purpose and in accordance with applicable ethical, legal, and data protection requirements.
Publications
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.
PubMed 42519206
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Model of Factors Influencing Reproductive Behavior and Perinatal Mental Health of Women Amidst War
- ClinicalTrials.gov ID
- NCT07551934
- Acronym / sponsor ID
- 26ГФ016-01
- Conditions
- Perinatal Mental Health, Reproductive Behavior, Women, Cohort Studies
- Keywords
- perinatal psychology, mental health, reproductive behavior, psychological trauma, PTSD, CB-PTSD, postpartum depression, pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Taras Shevchenko National University of KyivUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant women | – | Diagnostic Test: Psychological Assessment, Diagnostic Test: Routine Clinical Data CollectionWomen 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. |
| Pregnant women | – | Diagnostic Test: Psychological Assessment, Diagnostic Test: Routine Clinical Data CollectionWomen with an ongoing pregnancy at the time of enrolment, regardless of gestational age. |
| Postpartum women | – | Diagnostic Test: Psychological Assessment, Diagnostic Test: Routine Clinical Data CollectionWomen who have given birth and are within 12 months postpartum at the time of enrolment. |
| Partners | – | Diagnostic Test: Psychological AssessmentPartners of enrolled women who provide informed consent and participate in the study as a supplementary dyadic subgroup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women will be recruited in Ukraine from healthcare settings providing reproductive, gynecological, pregnancy-planning, antenatal, childbirth, and postpartum care. The source population includes women across the reproductive continuum, including those not currently planning pregnancy, those planning pregnancy, those with an ongoing pregnancy, and those within 12 months after childbirth. Where feasible, consenting partners of enrolled women will also be included.
Key inclusion criteria (2 listed)
- able and willing to provide informed consent;
- aged 18 years or older.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological AssessmentA 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. | Diagnostic test | Non-pregnant women, Partners, Postpartum women, Pregnant women |
| Routine Clinical Data CollectionClinical 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. | Diagnostic test | Non-pregnant women, Postpartum women, Pregnant women |
Primary outcome
World Health Organization - Five Well-Being Index
Time frame: 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.
13 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
The City Birth Trauma Scale
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
The City Birth Trauma Scale (Partner version)
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment, where applicable.
The Birth Satisfaction Scale - Revised
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Desire to Avoid Pregnancy Scale
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
London Measure of Unplanned Pregnancy
Time frame: Baseline, 3 months, and 12 months after enrolment.
Maternal and Partner Sex During Pregnancy Scales
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Motivations Against Sex Questionnaire
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Domestic Violence Myth Acceptance Scale
Time frame: Baseline and 12 months after enrolment.
General Anxiety Disorder - 7
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Impact of Events Scale - Revised
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Suicide Crisis Inventory - 2 Short Form
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Adverse Childhood Experiences Questionnaire
Time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 42519206Krupelnytska 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications from this study will be made available. Shared data may include questionnaire-derived variables, selected longitudinal outcome measures, and other study variables contained in the final anonymized analytic dataset. Direct identifiers will not be shared. Variables that could create a meaningful risk of re-identification, including information used for follow-up administration or dyadic linkage, will be removed, aggregated, or otherwise protected before data sharing. Data shared with external researchers will be limited to the minimum necessary for the approved purpose and in accordance with applicable ethical, legal, and data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Mental Health and Reproductive Behavior, run by Taras Shevchenko National University of Kyiv at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazar Yatsenko, MSc (+380733700423, nazaryatsenko@knu.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization - Five Well-Being Index (time frame: Baseline, 3 months, 6 months, and 12 months after enrolment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.