NCT07551934

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 20, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

perinatal psychologymental healthreproductive behaviorpsychological traumaPTSDCB-PTSDpostpartum depressionpregnancysexual healthUkrainewar-affected population

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3 months, 6 months, and 12 months after enrolment.

Secondary Outcomes (13)

  • 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.

  • +8 more secondary outcomes

Other Outcomes (1)

  • Assessment, Care, and Trust in Pregnant and New Mothers

    Baseline, 3 months, 6 months, and 12 months after enrolment.

Study Arms (4)

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.

Diagnostic Test: Psychological AssessmentDiagnostic Test: Routine Clinical Data Collection

Pregnant women

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

Diagnostic Test: Psychological AssessmentDiagnostic Test: Routine Clinical Data Collection

Postpartum women

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

Diagnostic Test: Psychological AssessmentDiagnostic Test: Routine Clinical Data Collection

Partners

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

Diagnostic Test: Psychological Assessment

Interventions

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.

Non-pregnant womenPartnersPostpartum womenPregnant women

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.

Non-pregnant womenPostpartum womenPregnant women

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Reproductive BehaviorPsychological Well-BeingPsychological TraumaStress Disorders, Post-TraumaticDepression, Postpartum

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Study Officials

  • Liudmyla Krupelnytska, DSc

    Taras Shevchenko National University of Kyiv

    STUDY DIRECTOR

Central Study Contacts

Nazar Yatsenko, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
De-identified individual participant data and supporting documents will become available after publication of the primary study results and completion of data cleaning and de-identification procedures.
Access Criteria
Data may be shared through an open repository for fully anonymised datasets.
More information