Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2332 participants
OBSERVATIONAL
2022-09-01
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Perinatal women
Women will be recruited in their first trimester of pregnancy and followed-up until 6 months post-partum. This is the 'exposed' group.
Screening 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.
Non-perinatal women
Non-perinatal women will be recruited as the 'non-exposed' group and followed-up over the same duration as the perinatal group.
Screening 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.
Interventions
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Screening 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.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health and Neuro Sciences, India
OTHER
Dr. Rajendra Prasad Government Medical College
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Gracia Fellmeth, DPhil
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Dr Rajendra Prasad Government Medical College
Kangra, Himachal Pradesh, India
National Institute of Mental Health and Neuro Sciences
Bengaluru, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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Ashok Verma
Role: primary
M. Thomas Kishore
Role: primary
References
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Fellmeth G, Kishore MT, Verma A, Desai G, Bharti O, Kanwar P, Singh S, Thippeswamy H, Chandra PS, Kurinczuk JJ, Nair M, Alderdice F. Perinatal mental health in India: protocol for a validation and cohort study. J Public Health (Oxf). 2021 Oct 8;43(Suppl 2):ii35-ii42. doi: 10.1093/pubmed/fdab162.
Other Identifiers
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10-20
Identifier Type: -
Identifier Source: org_study_id