Online psychosocial support for pregnant women after a fetal anomaly diagnosis
Official title: Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly: Randomised Controlled Trial
Run by Sakarya University · NCT07084103 · Data updated 2026-11-12
This study tests an online psychosocial support program to help pregnant women told their fetus may have an anomaly cope and protect their mental health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Sakarya University Academic / other |
| Locations | 1 site (Sakarya, Türkiye/Sakarya) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | September 30, 2025 |
| Study ends | March 31, 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT07084103 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women over age 18 with a high-risk dual/triple screening result or ultrasound findings suggesting fetal anomaly, who have decided to continue the pregnancy, have had at least one hospital visit after diagnosis, can communicate without major psychiatric disorders, and can use online services.
✕Probably not a fit
Women planning termination, those under 18, those with conditions that prevent expressing themselves, those without internet access, or anyone who does not meet the study's inclusion criteria are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project begins with qualitative interviews to identify the specific psychosocial support needs of pregnant women carrying fetuses at risk of anomaly, then uses those findings to develop a structured online support program. In a randomized controlled design, eligible women who choose to continue their pregnancy and have high-risk screening or ultrasound findings are assigned to the online program or to routine care. Mental health, coping, and quality-of-life outcomes will be measured with standardized tools to compare the groups. The trial is led by Sakarya University in Türkiye and delivered remotely through online modules.
Why it matters
Potential benefit: If successful, the intervention could reduce anxiety and improve coping and quality of life for pregnant women facing a fetal anomaly diagnosis.
How similar studies have gone: Prior in-person psychosocial interventions for prenatal anomaly diagnoses have shown reductions in distress, and early studies of online perinatal support programs have shown promising but mixed results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * In her current pregnancy, the results of the dual or triple screening test (a screening test result of 1:50 or 1:100 is considered a high risk for Down syndrome (Şirin, 2020) and/or ultrasound findings (physical/anatomical and congenital anomalies) indicate a high risk of foetal abnormalities, * Decision to continue the pregnancy, * Being over 18 years of age, * Having received hospital services at least once after the initial diagnosis (this criterion was added to enable the pregnant woman to evaluate the services she received from the hospital after the diagnosis and to express her expectations beyond the services provided) * No mental or psychological disorders that would make it difficult to express oneself, * Voluntary participation in the study. Exclusion Criteria: • Pregnant women who do not meet the inclusion criteria will be excluded from the sample.
Where it's running
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Sakarya University
Sakarya, Türkiye/Sakarya, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Semiha Ünkazan, Master of Licance
- Email: semihaunkazan@sakarya.edu.tr
- Phone: +905312052045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.