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

NCT06594952 | Not Yet Recruiting

• 1 other identifier: Maternal psychology on anomaly
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate maternal mental health during antenatal and postnatal periods after Ultrasonography diagnosis of fetal anomalies.

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (1)

• Difference in anxiety scores between the study groups

  using the state-trait anxiety inventory scale (STAI).

  4 weeks

Secondary Outcomes (1)

• Difference in Depression scores between the study groups

  4 weeks

Study Arms (3)

minor anomalies group

pregnant women with minor fetal structural anomaly detected by ultrasound.

Other: Questionnaire and Physical Exam

major anomalies group

pregnant women with major fetal structural anomaly detected by ultrasound

Other: Questionnaire and Physical Exam

Control Group

Pregnant women with normal ultrasound.

Other: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam 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; major anomalies group; minor anomalies group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women receiving obstetric care at our tertiary perinatal care

You may qualify if:

• 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

You may not qualify if:

• \- Women with history of psychiatric disorders.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Surveys and Questionnaires; Restraint, Physical

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Ahmed Abbas Professor, MD

CONTACT

+201003385183; ahmedabbas@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share