Mental DisorderNCT06594952
Evaluation of Maternal Mental Health Following Ultrasonography Detection of Fetal Congenital Anomalies
An observational study of Mental Disorder, run by Assiut University.
Trial summary
The purpose of this study is to evaluate maternal mental health during antenatal and postnatal periods after Ultrasonography diagnosis of fetal anomalies. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Sep 2025
- How long will I take part?
- 4 Weeks
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women receiving obstetric care at our tertiary perinatal care
Who may be able to join
- Pregnant women with confirmed pregnancy with viable fetus (whether singleton or multiple)
- Fetal anomaly should be diagnosed with ultrasonography (whether minor or major) after 12 weeks of gestational age
Who cannot join
- Women with history of psychiatric disorders.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate maternal mental health during antenatal and postnatal periods after Ultrasonography diagnosis of fetal anomalies.
Read the detailed description
Fetal congenital anomalies are responsible for a great deal of abortions in desired pregnancies . In clinical practice, prenatal screening programs in 1st and 2nd trimester target both chromosomal and structural abnormalities. These congenital anomalies are classified as minor and major anomalies than may lead to death or stillbirth . Half of all anomalies are detectable during weeks 18-22 of pregnancy. Due to the advances occurring in Ultrasonography and screening paradigms, the rate of diagnosed anomalies is increasing dramatically which in turn leading to psychological distress in the pregnant mother. Receiving a diagnosis of fetal anomaly is a highly stressful and potentially traumatic event that can elicit immediate feelings of grief, loss, anger, depression, and anxiety. However, the foreknowledge of a fetal anomaly during pregnancy may enable the mother to prepare mentally resulting in reduced maternal stress after delivery. The American College of Medical Genetics recommends underscoring the importance of psychological assessment and substantive communication with parents facing a prenatal diagnosis of fetal anomaly. Despite the accessibility of establishing the significant symptoms of maternal psychological distress, the evidence on the definite nature of this distress in consideration to other life stressors and an accurate the prediction of women vulnerability in the critical period have not been clear yet due to many methodological issues. Identification of women at highest risk for poor adaptation to the diagnosis may allow for targeted psychological support services for those most vulnerable.
- Conditions
- Mental Disorder
- Being tested
- Questionnaire and Physical Exam
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Diagnosis of Anxiety using the state-trait anxiety inventory scale (STAI). Depression using Edinburgh Postnatal Depression Scale (EPDS)
- Coping using the Brief Coping Scale
- Socioeconomic using the Socioeconomic Scale of Egypt
- Personality using the short-form Eysenck Personality Questionnaire-Revised (EPQ-R)
- Behaviour using Impact of Erect Scale (IES-22)
| Study group | Role | What they receive |
|---|---|---|
| minor anomalies group | pregnant women with minor fetal structural anomaly detected by ultrasound. Receives: Other: Questionnaire and Physical Exam | |
| major anomalies group | pregnant women with major fetal structural anomaly detected by ultrasound Receives: Other: Questionnaire and Physical Exam | |
| Control Group | Pregnant women with normal ultrasound. Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in anxiety scores between the study groups
using the state-trait anxiety inventory scale (STAI).
Measured: 4 weeks
Secondary outcomes (1)
Difference in Depression scores between the study groups
Depression using Edinburgh Postnatal Depression Scale (EPDS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areej Abdalrahman Khamees, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594952
- Sponsor's protocol ID
- Maternal psychology on anomaly
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maternal Mental Health Following Ultrasonography Detection of Fetal Congenital Anomalies
- ClinicalTrials.gov ID
- NCT06594952
- Acronym / sponsor ID
- Maternal psychology on anomaly
- Conditions
- Mental Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (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 purpose of this study is to evaluate maternal mental health during antenatal and postnatal periods after Ultrasonography diagnosis of fetal anomalies.
Detailed description
Fetal congenital anomalies are responsible for a great deal of abortions in desired pregnancies . In clinical practice, prenatal screening programs in 1st and 2nd trimester target both chromosomal and structural abnormalities. These congenital anomalies are classified as minor and major anomalies than may lead to death or stillbirth . Half of all anomalies are detectable during weeks 18-22 of pregnancy. Due to the advances occurring in Ultrasonography and screening paradigms, the rate of diagnosed anomalies is increasing dramatically which in turn leading to psychological distress in the pregnant mother. Receiving a diagnosis of fetal anomaly is a highly stressful and potentially traumatic event that can elicit immediate feelings of grief, loss, anger, depression, and anxiety. However, the foreknowledge of a fetal anomaly during pregnancy may enable the mother to prepare mentally resulting in reduced maternal stress after delivery. The American College of Medical Genetics recommends underscoring the importance of psychological assessment and substantive communication with parents facing a prenatal diagnosis of fetal anomaly. Despite the accessibility of establishing the significant symptoms of maternal psychological distress, the evidence on the definite nature of this distress in consideration to other life stressors and an accurate the prediction of women vulnerability in the critical period have not been clear yet due to many methodological issues. Identification of women at highest risk for poor adaptation to the diagnosis may allow for targeted psychological support services for those most vulnerable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| minor anomalies group | – | Other: Questionnaire and Physical Exampregnant women with minor fetal structural anomaly detected by ultrasound. |
| major anomalies group | – | Other: Questionnaire and Physical Exampregnant women with major fetal structural anomaly detected by ultrasound |
| Control Group | – | Other: Questionnaire and Physical ExamPregnant women with normal ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women receiving obstetric care at our tertiary perinatal care
Key inclusion criteria (2 listed)
- Pregnant women with confirmed pregnancy with viable fetus (whether singleton or multiple)
- Fetal anomaly should be diagnosed with ultrasonography (whether minor or major) after 12 weeks of gestational age
Key exclusion criteria (1 listed)
- Women with history of psychiatric disorders.
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 |
|---|---|---|
| Questionnaire and Physical ExamDiagnosis of Anxiety using the state-trait anxiety inventory scale (STAI). Depression using Edinburgh Postnatal Depression Scale (EPDS) * Coping using the Brief Coping Scale * Socioeconomic using the Socioeconomic Scale of Egypt * Personality using the short-form Eysenck Personality Questionnaire-Revised (EPQ-R) * Behaviour using Impact of Erect Scale (IES-22) | Other | Control Group, major anomalies group, minor anomalies group |
Primary outcome
Difference in anxiety scores between the study groups
Time frame: 4 weeks
using the state-trait anxiety inventory scale (STAI).
1 secondary outcome
Difference in Depression scores between the study groups
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, run by Assiut University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abbas Professor, MD (+201003385183, ahmedabbas@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in anxiety scores between the study groups (time frame: 4 weeks). 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 19 Sep 2024.