Understanding mental health in perinatal women in India
Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
This study looks at mental health issues in pregnant and new mothers in India to see how aware they are of these problems and to find out how common they are in low-income areas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2332 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 2 sites (Kangra, Himachal Pradesh and 1 other locations) |
| Trial ID | NCT05485701 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the understanding of mental health disorders among perinatal women in India. It consists of three phases: the first phase will assess women's awareness of mental illness and the acceptability of screening for mental disorders. The second phase will validate screening tools against a gold standard, while the third phase will establish the prevalence and risk factors for mental disorders among perinatal and non-perinatal women. The study focuses on low-income settings to address mental health challenges in these populations.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 to 45 years, post-partum women within 1-12 months after giving birth, and non-perinatal women aged 18 to 45 years.
Not a fit: Patients outside the age range of 18 to 45 years or those not currently pregnant or post-partum may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health screening and support for perinatal women in India.
How similar studies have performed: Other studies have shown success in addressing mental health in perinatal populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kangra, Himachal Pradesh and 1 other locations
- Dr Rajendra Prasad Government Medical College — Kangra, Himachal Pradesh, India (Recruiting)
- National Institute of Mental Health and Neuro Sciences — Bengaluru, Karnataka, India (Recruiting)
Study contacts
- Principal investigator: Gracia Fellmeth, DPhil — University of Oxford
- Study coordinator: Gracia Fellmeth, DPhil
- Email: gracia.fellmeth@ndph.ox.ac.uk
- Phone: 00441865289745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.