Evidence map›Paper›PMID 39871821›Full record

ArticleBJOG : an international journal of obstetrics and gynaecology2025

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

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 and 1 more

Abstract read
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In one paragraph

Article in BJOG : an international journal of obstetrics and gynaecology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Mridula ShankarGender and Women's Health Unit, Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia.ORCID https://orcid.org/0000-0002-4652-6396
Umesh CharantimathWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.
Ashwini DandappanavarWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.
Alya HazfiariniGender and Women's Health Unit, Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia.
Yeshita V PujarWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.
Manjunath S SomannavarWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.
Sara RushwanConcept Foundation, Geneva, Switzerland.
Joshua P VogelMaternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia.
A Metin GülmezogluConcept Foundation, Geneva, Switzerland.ORCID https://orcid.org/0000-0003-4674-0998
Shivaprasad S GoudarWomen's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.
Meghan A BohrenGender and Women's Health Unit, Nossal Institute for Global Health, School of Population and Global Health, University of Melbourne, Carlton, Victoria, Australia.

Funding

Merck & Co. Inc.
6 · The paper itself

Abstract

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

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

settingPrimary, 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.

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

resultsPregnant 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.

conclusionAnticipated 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.

Indexed as

Patient ParticipationPatient SelectionPregnant PeopleRandomized Controlled Trials as TopicAdultFemaleFocus GroupsHumansIndiaPregnancyQualitative Researchclinical trialsIndiamaternal healthpregnancyqualitative researchresearch participation

Identifiers

PMID39871821
PMCPMC11969915

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.