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Not yet recruiting NCT06594952

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

Observational Mental Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire and Physical Exam.
Who it may be relevant to
Registry conditions: Mental Disorder. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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)

Primary outcome measures

  • Difference in anxiety scores between the study groups [Time frame: 4 weeks]
Secondary outcome measures (1)
  • Difference in Depression scores between the study groups [Time frame: 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06594952 · Maternal psychology on anomaly

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗