Factors Influencing Pregnant Women's Participation in Randomised Clinical Trials in India: A Qualitative Study

IF 4.3 1区医学 Q1 OBSTETRICS & GYNECOLOGY Bjog-An International Journal of Obstetrics and Gynaecology Pub Date : 2025-01-28 DOI:10.1111/1471-0528.18074

Mridula Shankar, Umesh Charantimath, Ashwini Dandappanavar, Alya Hazfiarini, Yeshita V. Pujar, Manjunath S. Somannavar, Sara Rushwan, Joshua P. Vogel, A. Metin Gülmezoglu, Shivaprasad S. Goudar, Meghan A. Bohren

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Abstract

Objective

To explore factors affecting participation of pregnant women in randomised clinical trials in Belagavi, Karnataka, India.

Design

A qualitative study using semi-structured in-depth interviews and focus group discussions as data collection methods.

Setting

Primary, secondary and tertiary health facilities and their community catchment areas in Belagavi district.

Sample

Thirty-three in-depth interviews with health workers and previous participants of a pregnancy-focused trial, and 12 focus group discussions with currently pregnant women who had not previously participated in a clinical trial, family and community members, and accredited social health activists.

Methods

Inductive thematic analysis with a team-based approach to interpretation in the study context.

Results

Pregnant women were often unable to distinguish between maternal health programmes and trial interventions. Among previous trial participants, expectations of higher quality care were a key motivation for trial participation. Household gendered power relations and trust in the health workforce influenced decisional dynamics regarding participation. Health workers vouched for trial safety, once they assessed the intervention as acceptable. Trial Implementation by the health workforce required understanding and navigating pregnancy-related beliefs and practices in communities.

Conclusion

Anticipated health benefits, improved healthcare access, and trust in health workers are facilitators of trial participation. Engaging primary decision-makers is essential due to household gender dynamics. Trials must integrate strategies that clarify the distinct goals of research versus clinical care.

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影响印度孕妇参与随机临床试验的因素：一项定性研究

目的：探讨影响印度卡纳塔克邦Belagavi地区孕妇参与随机临床试验的因素。设计：采用半结构化深度访谈和焦点小组讨论作为数据收集方法的定性研究。环境：贝拉加维地区的初级、二级和三级保健设施及其社区集水区。样本：对卫生工作者和以前参加过以怀孕为重点的试验的人进行33次深入访谈，并与以前没有参加过临床试验的目前怀孕的妇女、家庭和社区成员以及经认可的社会卫生活动家进行12次焦点小组讨论。方法：采用归纳主题分析方法，运用团队分析方法对研究语境进行解读。结果：孕妇往往无法区分产妇保健方案和试验干预措施。在先前的试验参与者中，对更高质量护理的期望是参与试验的主要动机。家庭性别权力关系和对卫生工作人员的信任影响了有关参与的决策动态。卫生工作者一旦评估干预措施是可接受的，就会保证试验的安全性。卫生工作人员的试验实施需要了解和引导社区中与怀孕有关的信仰和做法。结论：预期的健康效益、改善的医疗服务可及性和对卫生工作者的信任是促进试验参与的因素。由于家庭性别动态，主要决策者的参与至关重要。试验必须整合策略，明确研究与临床护理的不同目标。

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来源期刊

Bjog-An International Journal of Obstetrics and Gynaecology 医学-妇产科学

CiteScore

10.90

自引率

5.20%

发文量

345

审稿时长

3-6 weeks

期刊介绍： BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.

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