Perinatal Mental Health for Refugee Women

Perinatal Depression Clinical Trial

— PMH-RW  

Official title:

Perinatal Mental Health for Refugee Women. An International Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654987
• Other study ID #: 21-PSI-2022
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2022
• Source: Universidad Nacional de Educación a Distancia
• Contact: Elisa Estebanez, PhD
• Phone: +34913987589
• Email: mestebanez[@]pas.uned.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 1, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Perinatal Depression

Locations

Country	Name	City	State
Poland	Magdalena Chrzan-Detkos	Gdansk
Ukraine	Lyudmyla Krupelnytska	Kiev

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Nacional de Educación a Distancia	Taras Shevchenko National University of Kyiv, University of Gdansk

Countries where clinical trial is conducted

Poland,  Ukraine, 

References & Publications (1)

Chrzan-Detkos, 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Primary	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	baseline
Primary	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	baseline
Primary	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	baseline
Primary	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	baseline