PMH-RW: Perinatal Mental Health for Refugee Women

Sponsor
Universidad Nacional de Educación a Distancia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05654987
Collaborator
University of Gdansk (Other), Taras Shevchenko National University of Kyiv (Other)
600
2
10
300
30

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Perinatal Mental Health for Refugee Women. An International Study
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Jul 31, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Depression Symptoms [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

    2. Generalized anxiety disorder screener GAD- 7 [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

    3. Impact of Event Stress-Revise [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

    4. Ten-Item Personality Inventory [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

    5. City Birth Questionnaire [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Magdalena Chrzan-Dętkoś Gdańsk Poland
    2 Lyudmyla Krupelnytska Kiev Ukraine

    Sponsors and Collaborators

    • Universidad Nacional de Educación a Distancia
    • University of Gdansk
    • Taras Shevchenko National University of Kyiv

    Investigators

    • Principal Investigator: Maria F. Rodriguez, Professor, UNED

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Universidad Nacional de Educación a Distancia
    ClinicalTrials.gov Identifier:
    NCT05654987
    Other Study ID Numbers:
    • 21-PSI-2022
    First Posted:
    Dec 16, 2022
    Last Update Posted:
    Dec 16, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universidad Nacional de Educación a Distancia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2022