Perinatal DepressionPMH-RWNCT05654987
Perinatal Mental Health for Refugee Women
An observational study of Perinatal Depression, run by Universidad Nacional de Educación a Distancia at 2 sites in 2 countries.
Trial summary
Since February 24th, 2022, the beginning of Russia's aggression against Ukraine, more than 80,000 women were expected to give birth. Therefore, understanding the impact of war on the perinatal health of women is an important requisite to improve perinatal care. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Depression
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2022to 1 Oct 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of women during the perinatal period. The rationale is to evaluate women throughout their pregnancy, and during 1 year after childbirth
The inclusion criteria at baseline are:
.Being pregnant or a biological mother of a child till twelve months of age or younger.
.Women 18 years of age or older.
.Being a war refugee from Ukraine (entrance to UE countries from 24.02.22) or staying in Ukraine after/during the war.
.Consenting to participate in the study.
The exclusion criteria are:
. Not being currently pregnant or not being the biological mother of a child 12 months of age or younger.
.Women younger than 18 years of age.
. Not consenting to participate in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site, 1 recruiting
- Recruiting
Magdalena Chrzan-Dętkoś
Gdansk
Magdalena Chrzan-Dętkoś, Professor, Magdalena Chrzan-Dętkoś <magdalena.chrzan-detkos@ug.edu.pl>
Ukraine1 site, 1 recruiting
- Recruiting
Lyudmyla Krupelnytska
Kiev
Lyudmyla Krupelnytska, Phd, krlyuda@gmail.com
About this study
Official title: Perinatal Mental Health for Refugee Women. An International Study
Since February 24th, 2022, the beginning of Russia's aggression against Ukraine, more than 80,000 women were expected to give birth. Therefore, understanding the impact of war on the perinatal health of women is an important requisite to improve perinatal care.
Read the detailed description
In general, even in non-war conditions, the perinatal period (from pregnancy to the first year after childbirth) is a vulnerable time. The onset and recurrence of mental disorders are high - it is estimated that 1 in 5 women would develop a perinatal mental disorder with perinatal depression, anxiety disorders, and posttraumatic stress disorder (PTSD) as the leading diagnoses. The experience of war and forced migration may double the risk for mothers and infants. It is highlighted that the experience of war or forced refuge and the associated stress, anxiety, and destabilization have various long-lasting negative consequences for mental health, with high prevalence rates of depression and post-traumatic stress disorder (PTSD). According to clinicians working with the refugee population, a group of pregnant women and new mothers is an especially vulnerable group of the migrant population "in a precarious situation in a foreign country, when the sense of inner homelessness can easily develop, the capacity for empathy and intuitive parenting can be weakened. This may destabilize the maternal/parental function". Studies conducted in war-affected Syria indicated a high percentage (28.2%) of women scoring higher on the postpartum depression scale . Also, according to other studies, high maternal anxiety is associated with a twofold increase in the risk of probable mental disorders in children. The war experience is also a risk factor for adverse, negative pregnancy and childbirth outcomes. It can result in premature birth and low birth weight, which is also observed in a population exposed to armed conflict. However, the rate of preterm births, stillbirths and miscarriages depends on direct exposure to conflict. For example, the adverse outcomes are often related to exposure to chemicals, radiation, exhaust fumes, contaminated water, or food during wartime.
The main aim of this prospective study is to investigate the impact of the war on perinatal mental health: depression, anxiety, post-traumatic stress and birth trauma symptoms on the course of the pregnancy and postpartum period. And also aim to assess the possible protective factors (such as personality traits, social support, sociodemographic characteristics, and access to medical/mental health services ). The research will focus on the two groups of war-affected women in the perinatal period: war refugees in European countries (external refugees) and women who decided to stay in Ukraine (in the same place of residence or as internal refugees).
- Conditions
- Perinatal Depression
- Keywords
- post partum depression, post traumatic stress disorder, anxiety, birth trauma
- Medical subject headings
- Depression, Postpartum, Stress Disorders, Post-Traumatic, Anxiety Disorders, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnat women | refugee internal or external pregnant women from Ukraine | |
| Post partum women | refugee internal or external women during postpartum period (one year after give birth) from Ukranie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms
The Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) This scale includes ten items which assess symptoms of sadness, anxiety and thoughts related to death. The scores range goes from 0 to 30. The cut-off values of 10 or higher and 13 or higher are most often used to identify women who might have depression. 13 has been shown the most useful cut off point established by reviews of international
Measured: baseline
Generalized anxiety disorder screener GAD- 7
Generalized anxiety disorder screener GAD- 7 (Spitzer, Kroenke, Williams, Löwe, 2006).
The GAD-7 total score ranges from 0 to 21. The scale's total score indicates the level of anxiety symptoms, with higher scores reflecting a greater anxiety severity. Scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety, respectivel. When screening for an anxiety disorder, a recommended cut-off point for referral for further evaluation is ten or greater
Measured: baseline
Impact of Event Stress-Revise
A revised version of the Impact of Event Stress-Revised by Weiss and Marmar (1997) The revised version of the Impact of Event Scale (IES-r) has seven additional questions and a scoring range of 0 to 88.
On this test, scores that exceed 24 can be quite meaningful. 24 or more - PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms. 33 and above - This represents the best cutoff for a probable diagnosis of PTSD 37 or more
Measured: baseline
Ten-Item Personality Inventory
Ten-Item Personality Inventory ( (Gosling, Rentfrow, and Swann Jr., 2003) The scores range for each scale is from 2 to 14 (two points on each scale; the scores range for each point is from 1 to 7
Measured: baseline
City Birth Questionnaire
City Birth Questionnaire (Ayers et al., 2018) aims to assess PTSD symptoms associated with childbirth according to DSM-5 criteria. It contains 29 items related to the DSM-5 diagnostic criteria, and the remaining two questions are related to the DSM-IV criteria. This questionnaire aims to determine the subjective feeling of discomfort related to a specific traumatic event. The scores range from 0 to 60. AS the authors has pointed out the scores for percentiles are: 25th = 3, 50th = 9, 75th = 18
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Dec 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gdansk, Taras Shevchenko National University of Kyiv
- Responsible party
- Sponsor
- Investigators
- Maria F. Rodriguez, Professor, Principal investigator, UNED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654987
- Sponsor's protocol ID
- 21-PSI-2022
- Acronym
- PMH-RW
- Status last verified
- Dec 2022
- First submitted
- 14 Nov 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chrzan-Dętkoś, M., Rodríguez-Muñoz, M. F., Krupelnytska, L., Morozova-Larina, O., Vavilova, A., López, H. G., Murawaska, N., and Radoš, S. N. (2022). Good Practices in Perinatal Mental Health for Women during Wars and Migrations: A Narrative Synthesis from the COST Action Riseup-PPD in the Context of the War in Ukraine. Clínica y Salud, 33(3), 127 - 135. https://doi.org/10.5093/clysa2022a14
Krupelnytska L, Yatsenko N, Chrzan-Detkos M, Murawska N, Vavilova A, Morozova-Larina O, Garcia Lopez HS, Rodriguez-Munoz MF. Bravery of giving birth in the homeland: pregnant women's and new mothers' decisions on staying in Ukraine during the war. BMC Public Health. 2026 Jun 17;26(1):2241. doi: 10.1186/s12889-026-28160-z.
PubMed 42310637Arguello-Gutierrez C, Rodriguez-Munoz MF, Chrzan-Detkos M, Costa R, Yatsenko N, Murawska N, Lockiewicz M, Nakic Rados S, Liakea I, Garcia-Lopez HS, Provencio M, Uka A, Krupelnytska L. Displacement and associated factors of childbirth-related posttraumatic stress disorder among Ukrainian perinatal women. Eur J Psychotraumatol. 2026 Dec;17(1):2652816. doi: 10.1080/20008066.2026.2652816. Epub 2026 Apr 22.
PubMed 42018470Rodriguez-Munoz MF, Chrzan-Detkos M, Uka A, Garcia-Lopez HS, Krupelnytska L, Morozova-Larina O, Vavilova A, Molotokas A, Murawska N, Le HN. The impact of the war in Ukraine on the perinatal period: Perinatal mental health for refugee women (pmh-rw) protocol. Front Psychol. 2023 Mar 13;14:1152478. doi: 10.3389/fpsyg.2023.1152478. eCollection 2023.
PubMed 36993880
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Mental Health for Refugee Women. An International Study
- ClinicalTrials.gov ID
- NCT05654987
- Acronym / sponsor ID
- PMH-RW / 21-PSI-2022
- Conditions
- Perinatal Depression
- Keywords
- post partum depression, post traumatic stress disorder, anxiety, birth trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Collaborators
- University of Gdansk, Taras Shevchenko National University of Kyiv
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 16 Dec 2022 (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.
Since February 24th, 2022, the beginning of Russia's aggression against Ukraine, more than 80,000 women were expected to give birth. Therefore, understanding the impact of war on the perinatal health of women is an important requisite to improve perinatal care.
Detailed description
In general, even in non-war conditions, the perinatal period (from pregnancy to the first year after childbirth) is a vulnerable time. The onset and recurrence of mental disorders are high - it is estimated that 1 in 5 women would develop a perinatal mental disorder with perinatal depression, anxiety disorders, and posttraumatic stress disorder (PTSD) as the leading diagnoses. The experience of war and forced migration may double the risk for mothers and infants. It is highlighted that the experience of war or forced refuge and the associated stress, anxiety, and destabilization have various long-lasting negative consequences for mental health, with high prevalence rates of depression and post-traumatic stress disorder (PTSD). According to clinicians working with the refugee population, a group of pregnant women and new mothers is an especially vulnerable group of the migrant population "in a precarious situation in a foreign country, when the sense of inner homelessness can easily develop, the capacity for empathy and intuitive parenting can be weakened. This may destabilize the maternal/parental function". Studies conducted in war-affected Syria indicated a high percentage (28.2%) of women scoring higher on the postpartum depression scale . Also, according to other studies, high maternal anxiety is associated with a twofold increase in the risk of probable mental disorders in children. The war experience is also a risk factor for adverse, negative pregnancy and childbirth outcomes. It can result in premature birth and low birth weight, which is also observed in a population exposed to armed conflict. However, the rate of preterm births, stillbirths and miscarriages depends on direct exposure to conflict. For example, the adverse outcomes are often related to exposure to chemicals, radiation, exhaust fumes, contaminated water, or food during wartime.
The main aim of this prospective study is to investigate the impact of the war on perinatal mental health: depression, anxiety, post-traumatic stress and birth trauma symptoms on the course of the pregnancy and postpartum period. And also aim to assess the possible protective factors (such as personality traits, social support, sociodemographic characteristics, and access to medical/mental health services ). The research will focus on the two groups of war-affected women in the perinatal period: war refugees in European countries (external refugees) and women who decided to stay in Ukraine (in the same place of residence or as internal refugees).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnat women | – | –refugee internal or external pregnant women from Ukraine |
| Post partum women | – | –refugee internal or external women during postpartum period (one year after give birth) from Ukranie |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of women during the perinatal period. The rationale is to evaluate women throughout their pregnancy, and during 1 year after childbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression Symptoms
Time frame: baseline
The Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) This scale includes ten items which assess symptoms of sadness, anxiety and thoughts related to death. The scores range goes from 0 to 30. The cut-off values of 10 or higher and 13 or higher are most often used to identify women who might have depression. 13 has been shown the most useful cut off point established by reviews of international
Generalized anxiety disorder screener GAD- 7
Time frame: baseline
Generalized anxiety disorder screener GAD- 7 (Spitzer, Kroenke, Williams, Löwe, 2006). The GAD-7 total score ranges from 0 to 21. The scale's total score indicates the level of anxiety symptoms, with higher scores reflecting a greater anxiety severity. Scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety, respectivel. When screening for an anxiety disorder, a recommended cut-off point for referral for further evaluation is ten or greater
Impact of Event Stress-Revise
Time frame: baseline
A revised version of the Impact of Event Stress-Revised by Weiss and Marmar (1997) The revised version of the Impact of Event Scale (IES-r) has seven additional questions and a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. 24 or more - PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms. 33 and above - This represents the best cutoff for a probable diagnosis of PTSD 37 or more
Ten-Item Personality Inventory
Time frame: baseline
Ten-Item Personality Inventory ( (Gosling, Rentfrow, and Swann Jr., 2003) The scores range for each scale is from 2 to 14 (two points on each scale; the scores range for each point is from 1 to 7
City Birth Questionnaire
Time frame: baseline
City Birth Questionnaire (Ayers et al., 2018) aims to assess PTSD symptoms associated with childbirth according to DSM-5 criteria. It contains 29 items related to the DSM-5 diagnostic criteria, and the remaining two questions are related to the DSM-IV criteria. This questionnaire aims to determine the subjective feeling of discomfort related to a specific traumatic event. The scores range from 0 to 60. AS the authors has pointed out the scores for percentiles are: 25th = 3, 50th = 9, 75th = 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- BackgroundChrzan-Dętkoś, M., Rodríguez-Muñoz, M. F., Krupelnytska, L., Morozova-Larina, O., Vavilova, A., López, H. G., Murawaska, N., and Radoš, S. N. (2022). Good Practices in Perinatal Mental Health for Women during Wars and Migrations: A Narrative Synthesis from the COST Action Riseup-PPD in the Context of the War in Ukraine. Clínica y Salud, 33(3), 127 - 135. https://doi.org/10.5093/clysa2022a14
- Derived from this study: PubMed 42310637Krupelnytska L, Yatsenko N, Chrzan-Detkos M, Murawska N, Vavilova A, Morozova-Larina O, Garcia Lopez HS, Rodriguez-Munoz MF. Bravery of giving birth in the homeland: pregnant women's and new mothers' decisions on staying in Ukraine during the war. BMC Public Health. 2026 Jun 17;26(1):2241. doi: 10.1186/s12889-026-28160-z.
- Derived from this study: PubMed 42018470Arguello-Gutierrez C, Rodriguez-Munoz MF, Chrzan-Detkos M, Costa R, Yatsenko N, Murawska N, Lockiewicz M, Nakic Rados S, Liakea I, Garcia-Lopez HS, Provencio M, Uka A, Krupelnytska L. Displacement and associated factors of childbirth-related posttraumatic stress disorder among Ukrainian perinatal women. Eur J Psychotraumatol. 2026 Dec;17(1):2652816. doi: 10.1080/20008066.2026.2652816. Epub 2026 Apr 22.
- Derived from this study: PubMed 36993880Rodriguez-Munoz MF, Chrzan-Detkos M, Uka A, Garcia-Lopez HS, Krupelnytska L, Morozova-Larina O, Vavilova A, Molotokas A, Murawska N, Le HN. The impact of the war in Ukraine on the perinatal period: Perinatal mental health for refugee women (pmh-rw) protocol. Front Psychol. 2023 Mar 13;14:1152478. doi: 10.3389/fpsyg.2023.1152478. eCollection 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maria F. Rodriguez, Professor principal investigator
UNED
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Depression, run by Universidad Nacional de Educación a Distancia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Estebanez, PhD (+34913987589, mestebanez@pas.uned.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Symptoms (time frame: baseline). The study lists 5 primary outcomes in all. 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 NCT05654987, which also lists 4 linked publications.
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 16 Dec 2022.