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NCT Number: NCT06594952

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Difference in anxiety scores between the study groups

    Time frame: 4 weeks

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

Secondary outcomes

  1. Difference in Depression scores between the study groups

    Time frame: 4 weeks

    Depression using Edinburgh Postnatal Depression Scale (EPDS)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abbas Professor, MD

CONTACT

[email protected]

+201003385183

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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