Evaluating screening tools for mental health in pregnant and postpartum women
Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools for Depression, Anxiety Disorders, Obsessive-compulsive Disorders and Posttraumatic Disorders in the Perinatal Period.
This study is trying to see if certain screening tools can help find mental health issues in pregnant and new moms so they can get the right support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 2 sites (Ghent, Oost-Vlaanderen and 1 other locations) |
| Trial ID | NCT05961306 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of a stepped screening protocol and its associated questionnaires for identifying mental health issues in women during the perinatal period. It focuses on conditions such as major depressive episodes, anxiety disorders, PTSD, and OCD, which often go undetected. The study will analyze the effectiveness of tools like the Edinburgh Postnatal Depression Scale and the Whooley questions in accurately identifying women at risk for these mental health challenges. By determining the sensitivity of these screening methods, the research seeks to improve referral processes for appropriate care.
Who should consider this trial
Good fit: Ideal candidates for this study are Dutch-speaking women aged 18 or older who are either in the antenatal period (20-24 weeks of pregnancy) or in the postnatal period (6 to 10 weeks after birth).
Not a fit: Patients who are under 18 years old, non-Dutch speaking, or outside the specified antenatal or postnatal periods will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and treatment of mental health issues in pregnant and postpartum women, enhancing their well-being and that of their families.
How similar studies have performed: Previous studies have shown promising results with similar screening approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older, antenatal period (20-24 th week of pregnancy) or postnatal period (6 to 10 weeks after birth) and Dutch-speaking. Exclusion Criteria: * \<18 years, non-Dutch speaking and outside the above mentioned period.
Where this trial is running
Ghent, Oost-Vlaanderen and 1 other locations
- AZ St Lucas — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, West-Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Gilbert MD Lemmens, Prof dr — University Hospital, Ghent
- Study coordinator: Rita RA Van Damme, Master
- Email: rita.vandamme@uzgent.be
- Phone: +32 9 3324394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.