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“库沙尔妈妈”项目的效果评估:一项基于群组的移动健康互动教育及社会支持干预对孕产妇和新生儿健康结局的影响——印度一项多中心随机对照试验的研究方案

Effectiveness of Kushal Maa, a group-based mhealth interactive education and social support intervention for maternal and neonatal health outcomes: study protocol for a multisite randomised controlled trial in India.

作者信息

El Ayadi Alison M, Duggal Mona, Gopalakrishnan Lakshmi, Bagga Rashmi, Singh Pushpendra, Lin Tracy, Bhan Anant, Saunik Sujata, Verma Garima Singh, Ahuja Alka, Kaur Jasmeet, Tugnawat Deepak, Gujarathi Shailendrakumar, Singh Abhishek, Khan Azaz, Chandke Dinesh, Dhir Shashi Kant, Dhakne-Palwe Supriya, Kumar Praveen, Patil Mrunal, Kumar Sonam, Vasaikar Nitin, Weil Laura, Diamond-Smith Nadia

机构信息

Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, California, USA

Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.

出版信息

BMJ Open. 2025 Jun 27;15(6):e104213. doi: 10.1136/bmjopen-2025-104213.


DOI:10.1136/bmjopen-2025-104213
PMID:40578858
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12207183/
Abstract

INTRODUCTION: Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women's postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, ), confirming feasibility and acceptability and preliminary effectiveness. The current study seeks to estimate the effectiveness of the intervention compared with standard care on maternal and neonatal health-related behaviours and health, characterise the mechanisms of intervention impact and evaluate the cost-effectiveness of the intervention in improving postpartum maternal and neonatal health compared with the standard of care. METHODS AND ANALYSIS: We will conduct a prospective, parallel block-randomised controlled trial with a 1:1 allocation ratio among 2100 pregnant women across three geographically diverse Indian states. Inclusion criteria for women: aged 18+years of age at enrolment, in the last trimester of pregnancy (30-33 weeks of gestation), with any parity, carrying single or multiple gestation (1-2), with knowledge of site-specific local language and had access to a mobile phone. Participants will be block-randomised in groups of 15. Intervention participants will receive 28 tailored education and support sessions weekly via audio/video conference facilitated by trained moderators (four prenatal and 24 weekly postpartum sessions through 6 months) and will be engaged in WhatsApp groups for health education videos and peer discussion via text chat. Control participants receive the standard of care. Data will be collected at four points: 30-33 weeks of pregnancy (enrolment), 6 weeks, 3 months and 6 months postpartum (endline). Investigators, outcome assessors and data analysts will be blinded to group allocation. Primary outcomes will be measured at 6 weeks, 3 months and 6 months post partum and include: postpartum depression (using Edinburgh Postnatal Depression Scale), exclusive breastfeeding and met need for postpartum family planning. Secondary outcomes include other maternal and child health knowledge, outcomes and maternal and newborn healthcare use indicators. We will use intention-to-treat analysis. Mixed-effects models will account for clustering due to the group-oriented delivery of the intervention and repeated measures. ETHICS AND DISSEMINATION: This study has been approved by the Health Ministry Screening Committee, Government of India and approved by ethics boards at the Post-Graduate Institute for Medical Education and Research, Chandigarh (Ref:001208, IEC-06/2022-2471), Maharashtra University of Health Sciences (Ref: MUHS/EC/06/2024), Sangath (Ref: AB_2022_81) and the University of California, San Francisco (Ref: 21-35730). All research activities will be performed in accordance with the Declaration of Helsinki. On completion, findings will be disseminated to stakeholders through diverse strategies. Results will be published in academic journals and presented at conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05268588 Clinical Trials Registry - India: CTRI/2022/07/043889.

摘要

引言:整个围产期的连续护理对于优化母婴健康至关重要;然而,产后存在明显差距,由于重大的后勤和社会文化障碍,不到一半的印度母亲接受产后护理,特别是对于城市周边和农村居民而言。为了克服这些障碍并减少女性产后的孤立感,我们的国际母婴健康临床医生和研究团队开发并进行了一项针对特定文化的移动互动教育和支持小组干预措施(),证实了其可行性、可接受性及初步有效性。本研究旨在评估与标准护理相比,该干预措施对母婴健康相关行为和健康状况的有效性,确定干预影响的机制,并评估与标准护理相比,该干预措施在改善产后母婴健康方面的成本效益。 方法与分析:我们将在印度三个地理位置不同的邦对2100名孕妇进行一项前瞻性、平行分组随机对照试验,分配比例为1:1。女性的纳入标准:入组时年龄18岁及以上,处于妊娠晚期(妊娠30 - 33周),任何胎次,单胎或多胎妊娠(1 - 2胎),通晓当地特定语言且能使用手机。参与者将以15人一组进行分组随机化。干预组参与者将通过由经过培训的主持人主持的音频/视频会议每周接受28次量身定制的教育和支持课程(产前4次,产后24次,为期6个月),并将加入WhatsApp群组观看健康教育视频并通过文本聊天进行同伴讨论。对照组参与者接受标准护理。数据将在四个时间点收集:妊娠30 - 33周(入组时)、产后6周、3个月和6个月(终末点)。研究人员、结果评估人员和数据分析人员将对分组情况保持盲态。主要结局将在产后6周、3个月和6个月进行测量,包括:产后抑郁(使用爱丁堡产后抑郁量表)、纯母乳喂养以及满足产后计划生育需求。次要结局包括其他母婴健康知识、结局以及母婴医疗保健使用指标。我们将采用意向性分析。混合效应模型将考虑由于干预措施以小组形式实施以及重复测量导致的聚类情况。 伦理与传播:本研究已获得印度政府卫生部筛查委员会批准,并获得昌迪加尔医学教育与研究研究生学院伦理委员会(参考编号:001208,IEC - 06/2022 - 2471)、马哈拉施特拉邦卫生科学大学(参考编号:MUHS/EC/06/2024)、Sangath(参考编号:AB_2022_81)以及加利福尼亚大学旧金山分校(参考编号:21 - 35730)的批准。所有研究活动将按照《赫尔辛基宣言》进行。研究完成后,将通过多种策略向利益相关者传播研究结果。结果将发表在学术期刊上并在会议上展示。 试验注册号:ClinicalTrials.gov:NCT05268588;印度临床试验注册中心:CTRI/2022/07/043889

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/56b4/12207183/5e2e51fdb17c/bmjopen-15-6-g004.jpg
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本文引用的文献

[1]
Women's healthcare access: assessing the household, logistic and facility-level barriers in India.

BMC Health Serv Res. 2025-2-27

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Int J Environ Res Public Health. 2020-8-19

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