Clinical trial NCT05654987: Perinatal Mental Health for Refugee Women
Official title: Perinatal Mental Health for Refugee Women. An International Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perinatal Depression
Keywords: post partum depression
post traumatic stress disorder
anxiety
birth trauma
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: University of Gdansk
name: Taras Shevchenko National University of Kyiv
First posted: 2022-12-16
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Depression Symptoms
timeFrame: baseline
measure: Generalized anxiety disorder screener GAD- 7
timeFrame: baseline
measure: Impact of Event Stress-Revise
timeFrame: baseline
measure: Ten-Item Personality Inventory
timeFrame: baseline
measure: City Birth Questionnaire
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Magdalena Chrzan-Dętkoś
city: Kiev
country: Ukraine
facility: Lyudmyla Krupelnytska
Study officials:
affiliation: UNED
name: Maria F. Rodriguez, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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