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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04792671
Other study ID # women mental health disorders
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2023

Study information

Verified date March 2021
Source Assiut University
Contact gellan Ahmed
Phone +201093663928
Email gillankaram@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. On the other hand, Depressive disorder in women mainly occurs during the first year after childbirth. It takes many forms according to the onset, severity, and duration of the symptoms including; Postpartum blues (PPB), Postpartum depression (PPD), and Postpartum psychosis (PPP). Lack of access to mental health services during the perinatal period is a significant public health concern that may worse outcome. So, we aimed to study prevalence of women mental health in Assiut governorate and evaluate possible risk factor for it


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - age 18 years -50 years. - No previous history of psychiatric, neurological or medical disease Exclusion Criteria: - intelligence equation less than 80 - have history of psychiatric, neurological or medical disease

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sociodemographic variables
age, residence, education of the mother and her husband, occupation of the mother and her husband, parity, gender, and age of the last baby.
Family affluence scale (FAS)
a four-item measure of family wealth, has been developed in the WHO Health Behaviour in School-aged Children Study as an alternative measure.
Edinburgh postnatal depression scale (EPDS)
s a questionnaire originally developed to assist in identifying possible symptoms of depression in the postnatal period. It also has adequate sensitivity and specificity to identify depressive symptoms in the antenatal period and is useful in identifying symptoms of anxiety. more than 9 is clinically diagnosed
Symptom Checklist 90 "SCL 90":
is a 90-item questionnaire used to assess psychological problems. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. More than 60 is considered clinically diagnosed

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Sambrook Smith M, Lawrence V, Sadler E, Easter A. Barriers to accessing mental health services for women with perinatal mental illness: systematic review and meta-synthesis of qualitative studies in the UK. BMJ Open. 2019 Jan 24;9(1):e024803. doi: 10.1136/bmjopen-2018-024803. — View Citation

Sharma V, Burt VK. DSM-V: modifying the postpartum-onset specifier to include hypomania. Arch Womens Ment Health. 2011 Feb;14(1):67-9. doi: 10.1007/s00737-010-0182-2. Epub 2010 Sep 25. — View Citation

Sheffield KM, Woods-Giscombé CL. Efficacy, Feasibility, and Acceptability of Perinatal Yoga on Women's Mental Health and Well-Being: A Systematic Literature Review. J Holist Nurs. 2016 Mar;34(1):64-79. doi: 10.1177/0898010115577976. Epub 2015 Apr 20. Revi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary measure the prevalence of DSM 5 psychiatric disorders in perinatal and postnatal through study completion, an average of 1 year
Primary measure of risk factor of DSM 5 psychiatric disorders in perinatal and postnatal through study completion, an average of 1 year
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