Postpartum DepressionNCT05997953
Screening of Postpartum Depression in Egyptian Women
An observational study of Postpartum Depression, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale as screening tool for Postpartum Depression among women delivering at Egyptian tertiary health care system, University Hospital, regarding Prevalence and risk factors. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Edinburgh Postnatal Depression Scale
- How many people
- 2,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: 2000 patients who underwent either vaginal birth or cesarean section at El-Hussien University Hospital and agreed for followup and participation in this study.
Who may be able to join
- All patients who underwent vaginal/cesarean delivery and reported for follow and willing to participate in the study.
Who cannot join
- Patients who were unwilling to participate in the study.
- Patients who are having difficulties comprehending the questionnaire of the study.
- Women who were on psychiatric medication during pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty od Medicine, Department of Obstetrics and Gynecology.
Cairo, Cairo Governorate
About this study
Official title: Assessment of the Edinburgh Postnatal Depression Scale as Screening Tool for Postpartum Depression Among Women Delivering at Egyptian Tertiary Care System University Hospital: Prevalence and Risk Factors Analysis
The goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale as screening tool for Postpartum Depression among women delivering at Egyptian tertiary health care system, University Hospital, regarding Prevalence and risk factors.
participants of this study with fill the Edinburgh Postnatal Depression Scale and their socio-demographic, obstetric and psychological data will be collected and analysed.
prevalence of postpartum depression in Egyptian women will be assessed as well as the associated risk factors
- Conditions
- Postpartum Depression
- Being tested
- Edinburgh Postnatal Depression Scale
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edinburgh Postnatal Depression ScaleOther
Edinburgh Postnatal Depression Scale used as screening tool for postpartum depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Number screening positive for possible postpartum depression by Arabic EPDS
Number of participants screening positive for possible postpartum depression, defined as a score of 13 or higher on the validated Arabic version of the Edinburgh Postnatal Depression Scale (EPDS) Participants with a positive screen (EPDS score ≥13) will be referred for psychiatric consultation for diagnostic confirmation and treatment of postpartum depression
Measured: 2 weeks postpartum
Secondary outcomes (1)
Sociodemographic, clinical, and psychosocial predictors of postpartum depression risk
Identification of sociodemographic, clinical, and psychosocial risk factors associated with screening positive for possible postpartum depression, as determined by bivariate and multivariate regression analyses of factors correlated with an Arabic EPDS score ≥13.
Sociodemographic factors will include maternal age, education level, occupation, socioeconomic status, etc.
Clinical factors will include obstetric history, delivery method, neonatal health status, etc.
Psychosocial factors will include social support, stress levels, family dynamics, etc.
Measured: At 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jul 2023
- Primary completion30 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997953
- Sponsor's protocol ID
- 520235
- Status last verified
- Feb 2025
- First submitted
- 3 Aug 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Edinburgh Postnatal Depression Scale as Screening Tool for Postpartum Depression Among Women Delivering at Egyptian Tertiary Care System University Hospital: Prevalence and Risk Factors Analysis
- ClinicalTrials.gov ID
- NCT05997953
- Acronym / sponsor ID
- 520235
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale as screening tool for Postpartum Depression among women delivering at Egyptian tertiary health care system, University Hospital, regarding Prevalence and risk factors.
participants of this study with fill the Edinburgh Postnatal Depression Scale and their socio-demographic, obstetric and psychological data will be collected and analysed.
prevalence of postpartum depression in Egyptian women will be assessed as well as the associated risk factors
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 2000 patients who underwent either vaginal birth or cesarean section at El-Hussien University Hospital and agreed for followup and participation in this study.
Key inclusion criteria (1 listed)
- All patients who underwent vaginal/cesarean delivery and reported for follow and willing to participate in the study.
Key exclusion criteria (3 listed)
- Patients who were unwilling to participate in the study.
- Patients who are having difficulties comprehending the questionnaire of the study.
- Women who were on psychiatric medication during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edinburgh Postnatal Depression ScaleEdinburgh Postnatal Depression Scale used as screening tool for postpartum depression | Other | – |
Primary outcome
Number screening positive for possible postpartum depression by Arabic EPDS
Time frame: 2 weeks postpartum
Number of participants screening positive for possible postpartum depression, defined as a score of 13 or higher on the validated Arabic version of the Edinburgh Postnatal Depression Scale (EPDS) Participants with a positive screen (EPDS score ≥13) will be referred for psychiatric consultation for diagnostic confirmation and treatment of postpartum depression
1 secondary outcome
Sociodemographic, clinical, and psychosocial predictors of postpartum depression risk
Time frame: At 2 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number screening positive for possible postpartum depression by Arabic EPDS (time frame: 2 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.