Perinatal Mental Health for Refugee Women (NCT05654987) | Clinical Trial Compass
UnknownNot Applicable
Perinatal Mental Health for Refugee Women
Poland, Ukraine600 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression Symptoms
Timeframe: baseline
2
Generalized anxiety disorder screener GAD- 7
Timeframe: baseline
3
Impact of Event Stress-Revise
Timeframe: baseline
4
Ten-Item Personality Inventory
Timeframe: baseline
5
City Birth Questionnaire
Timeframe: baseline
Trial details
NCT IDNCT05654987
SponsorUniversidad Nacional de Educación a Distancia