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

Not yet recruiting

• Conditions: Mental Disorder
• Interventions: Other: Questionnaire and Physical Exam

• Registration Number: NCT06594952
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Study Start: 2024-10-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
minor anomalies group	Questionnaire and Physical Exam	pregnant women with minor fetal structural anomaly detected by ultrasound.
major anomalies group	Questionnaire and Physical Exam	pregnant women with major fetal structural anomaly detected by ultrasound
Control Group	Questionnaire and Physical Exam	Pregnant women with normal ultrasound.

Primary Outcome Measures

Name	Time	Method
Difference in anxiety scores between the study groups	4 weeks	using the state-trait anxiety inventory scale (STAI).

Secondary Outcome Measures

Name	Time	Method
Difference in Depression scores between the study groups	4 weeks	Depression using Edinburgh Postnatal Depression Scale (EPDS)