Abstract
Preconception care is a vital part of maternal and child health that is currently underserved in the healthcare system of India. Before implementing an intervention, it is first important to understand the need, and then provide an opportunity to meet those needs in a compelling way to improve a mutually beneficial outcome, such as a healthy mother and baby in case of preconception care. The study is intended to be conducted in 10 villages in rural central India to test the feasibility of a preconception care package in a community-based setting. The RE-AIM framework guided study will be implemented through a Social Franchising approach in collaboration with the Department of Community Medicine of a tertiary care hospital. The Franchisor will be providing technical support using its existing staff, while the Franchisee, the respective village council, will provide minimal resources required to implement such initiatives at the village level. Auxiliary Nurse Midwives would be primary package providers, and social workers would be needed to present the idea. The trial aims to determine the 'felt need,' feasibility of implementation, and community acceptance of preconception care in a rural Indian context, and will guide future implementation trials on community-based delivery of preconception care to ensure that women enter pregnancy in good health.
Trial registration: CTRI/2022/07/044407.
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Not applicable.
Abbreviations
- ANM:
-
Auxiliary nurse midwife
- P4P:
-
Prepare for pregnancy
- PCC:
-
Preconception care
- RE-AIM:
-
Reach, effectiveness, adoption, implementation, maintenance
- WHO:
-
World health organization
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Acknowledgements
Thanks to Dr. Sophiya K, Dr. Radhika Sharma, Dr. Anuj Mundra, Dr. Arjun Kumar Jakasania, Dr. Amey Dhatrak, and Dr. Ashwini Kalantri for providing inputs during the draft development and reviewing the final edited version of the protocol. Collaborators Pre-conception Health Group: Sophiya K, Radhika Sharma, Anuj Mundra, Arjun Kumar Jakasania, Amey Dhatrak, Ashwini Kalantri: Department of Community Medicine, MGIMS, Sevagram, Maharashtra, India. Poonam Shivkumar (PS): Department of Obstetrics and Gynecology, MGIMS, Sevagram, Maharashtra, India.
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RK developed the initial trial protocol and trial intervention; RA contributed to the initial trial protocol and design; AR is the principal investigator and conceived the study, designed and contributed to the first and subsequent draft of the manuscript; CM, SG, and BG provided expertise in refining the study’s design and reviewed the final version of the manuscript. The final manuscript has been read and approved by all authors.
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Ethics Approval and Consent to Participate
The protocol for the study has been approved by the Institutional Ethics Committee (IEC) for Research on Human Subjects, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram (Ref MGIMS/IEC/COMMED/108/2022, Dated:11/06/2022) and the feasibility trial has been registered in CTRI (CTRI/2022/07/044407). The participant will be given a consent form in their preferred language that details the study procedures. Consent forms have been approved by the Institutional Ethics Committee, and participants will be required to read or have the document read to them. The study nurses will explain the research study to the participants and answer any questions that may arise. Before any study-related assessments, the participant will sign the informed consent document. Before agreeing to participate in the study, participants will be allowed to discuss it with their families or think about it. They will have the right to withdraw their consent at any time during the study. Participants will be given a copy of the signed informed consent form for their records. The rights and welfare of the participants will be protected by emphasizing to them that their clinical care will not suffer if they decline to participate in this study. The consent procedure will be recorded in the research log.
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Collaborators Pre-conception Health Group members are listed in acknowledgement section.
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Kolhe, R.S., Aggarwal, R., Raut, A.V. et al. Optimizing Health Before Pregnancy: Evaluating the Feasibility of Community-Based Preconception Care Package in Rural Central India. Glob Implement Res Appl 4, 24–39 (2024). https://doi.org/10.1007/s43477-023-00102-6
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DOI: https://doi.org/10.1007/s43477-023-00102-6