NCT04792671

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Keywords

womenmental health

Outcome Measures

Primary Outcomes (2)

  • measure the prevalence of DSM 5 psychiatric disorders in perinatal and postnatal

    through study completion, an average of 1 year

  • measure of risk factor of DSM 5 psychiatric disorders in perinatal and postnatal

    through study completion, an average of 1 year

Study Arms (2)

Perinatal group

females who are pregnancy

Behavioral: Sociodemographic variablesBehavioral: Family affluence scale (FAS)Behavioral: Edinburgh postnatal depression scale (EPDS)Behavioral: Symptom Checklist 90 "SCL 90":

postpartum group

female who get delivery(from day 1 up to 1 year)

Behavioral: Sociodemographic variablesBehavioral: Family affluence scale (FAS)Behavioral: Edinburgh postnatal depression scale (EPDS)Behavioral: Symptom Checklist 90 "SCL 90":

Interventions

age, residence, education of the mother and her husband, occupation of the mother and her husband, parity, gender, and age of the last baby.

Perinatal grouppostpartum group

a four-item measure of family wealth, has been developed in the WHO Health Behaviour in School-aged Children Study as an alternative measure.

Perinatal grouppostpartum group

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

Perinatal grouppostpartum group

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

Perinatal grouppostpartum group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This is study will take part in the Assiut government primary health centres in community

You may qualify if:

  • age 18 years -50 years.
  • No previous history of psychiatric, neurological or medical disease

You may not qualify if:

  • intelligence equation less than 80
  • have history of psychiatric, neurological or medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 30679296BACKGROUND
  • Sheffield KM, Woods-Giscombe 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.

  • 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.

MeSH Terms

Conditions

Wolman DiseasePsychological Well-Being

Interventions

Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Cholesterol Ester Storage DiseaseLipidosesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesInfant, Newborn, DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, resarcher OF Neurology and Psychiatry department

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share