Evaluation of Maternal Mental Health Following Ultrasonography Detection of Fetal Congenital Anomalies

NCT ID: NCT06594952

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-09-01

Brief Summary

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.

Conditions

Mental Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

minor anomalies group

pregnant women with minor fetal structural anomaly detected by ultrasound.

Questionnaire and Physical Exam

Intervention Type: OTHER

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)

major anomalies group

pregnant women with major fetal structural anomaly detected by ultrasound

Questionnaire and Physical Exam

Intervention Type: OTHER

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)

Control Group

Pregnant women with normal ultrasound.

Questionnaire and Physical Exam

Intervention Type: OTHER

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)

Interventions

Questionnaire and Physical Exam

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Women with history of psychiatric disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Areej Abdalrahman Khamees

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Abbas Professor, MD

Role: CONTACT

ahmedabbas@aun.edu.eg

+201003385183

Other Identifiers

Maternal psychology on anomaly

Identifier Type: -

Identifier Source: org_study_id