Perinatal Mental Health Study (PMHS) India

University of Oxford

Status

Enrolling

Conditions

Suicidal Ideation

PTSD

Depression

Anxiety

Somatization

Treatments

Diagnostic Test: Screening tools for common mental disorders

Study type

Observational

Funder types

Other

Identifiers

NCT05485701

10-20

Details and patient eligibility

About

The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.

Full description

The purpose of this observational study is to assess the mental health of perinatal women living in two low-income settings in India. The first phase will explore women's awareness of mental illness and acceptability of screening for mental disorders. The second phase will be a validation study, during which the psychometric properties of screening tools will be assessed against a gold standard. The third stage will comprise a cohort study, during which the prevalence of and risk factors for mental disorders among perinatal and non-perinatal women will be established.

Enrollment

2,332 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For Phase 1 (qualitative study) and Phase 2 (validation study):

Pregnant women:

Aged 18 to 45 years
Currently pregnant (any trimester)
Willing and able to give informed consent

Post-partum women:

Aged 18 to 45 years
Currently post-partum (between 1-12 months postpartum)
Willing and able to give informed consent

Non-perinatal women:

Aged 18 to 45 years
Not currently pregnant and not given birth in the past 12 months
Willing and able to give informed consent

For Phase 3 (prospective cohort study):

Perinatal women:

Aged 18 to 45 years
In early pregnancy (estimated gestational age <20 weeks) at recruitment
Not planning to relocate for the duration of the study period
Willing and able to give informed consent
Expressed a willingness to continue to participate for the four planned visits

Non-perinatal women:

Aged 18 to 45 years
Not currently pregnant and not given birth in the last 12 months
Not planning to relocate for the duration of the study period
Willing and able to give informed consent
Expressed a willingness to continue to participate for the four planned visits

Exclusion criteria

The participant may not enter the study if:

They have an acutely severe psychiatric illness which impairs their ability to take part in the study
They are not willing or able to provide informed consent

Other than for current severe psychiatric illness which affects ability to participate in the study, we will not exclude any participant on the basis of current or prior physical, psychological or psychiatric co-morbidities so long as she is willing to participate, her ability to take part is not compromised and her ability to give informed consent is not impaired by these conditions.