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Search / Trial NCT05485701

Perinatal Mental Health Study (PMHS) India

Launched by UNIVERSITY OF OXFORD · Aug 1, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Perinatal Post Partum Antenatal Low And Middle Income Country India Common Mental Disorders Screening Validation Prevalence Risk Factor

ClinConnect Summary

The Perinatal Mental Health Study (PMHS) in India is looking to learn more about mental health issues like depression, anxiety, and PTSD in women during and after pregnancy. This study aims to understand how these conditions affect women in India, with the hope of improving support and treatment options for them.

To participate in this study, women aged 18 to 45 who are either currently pregnant, have given birth within the last year, or are not currently pregnant can apply. Participants will need to attend four scheduled visits and provide their consent to take part in the study. It’s important to note that women with severe mental health issues that could prevent them from participating will not be included. Overall, this study is an opportunity for women to share their experiences and contribute to important research that could help others in the future.

Gender

FEMALE

Eligibility 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.

About University Of Oxford

The University of Oxford, a prestigious institution renowned for its excellence in research and education, serves as a leading clinical trial sponsor dedicated to advancing medical science and improving patient care. With a rich history of innovation and a multidisciplinary approach, the university leverages its extensive expertise in various fields, including medicine, public health, and biomedical research, to conduct rigorous clinical trials. Collaborating with healthcare professionals, industry partners, and regulatory bodies, the University of Oxford aims to translate groundbreaking research findings into effective therapies and interventions, contributing to the global effort of enhancing health outcomes.

Locations

Kangra, Himachal Pradesh, India

Bengaluru, Karnataka, India

Patients applied

0 patients applied

Trial Officials

Gracia Fellmeth, DPhil

Principal Investigator

University of Oxford

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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