RecruitingNCT05485701
Perinatal Mental Health Study (PMHS) India
Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
Sponsor
University of Oxford
Enrollment
2,332 participants
Start Date
Sep 1, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria26
- 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 Criteria4
- 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.
Interventions
DIAGNOSTIC_TESTScreening tools for common mental disorders
A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05485701
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