Perinatal Mental Health for Refugee Women

NCT05654987 | Unknown

• 1 other identifier: 21-PSI-2022
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 2

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.

Conditions

Perinatal Depression

Keywords

post partum depression; post traumatic stress disorder; anxiety; birth trauma

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Magdalena Chrzan-Dętkoś

Gdansk, Poland

RECRUITING

Lyudmyla Krupelnytska

Kiev, Ukraine

RECRUITING

Related Publications (2)

• 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

  BACKGROUND

• Rodriguez-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.

  PMID: 36993880 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Stress Disorders, Post-Traumatic; Anxiety Disorders; Birth Injuries

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Maria F. Rodriguez, Professor

  UNED

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Estebanez, PhD

CONTACT

+34913987589; mestebanez@pas.uned.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 16, 2022
• Study Start: December 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: October 1, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); UA (1)