Evidence map›Paper›PMID 35907873›Full record

ArticleReproductive health2022

Toward an intravaginal device to detect risk of preterm labor: a user-centered design approach in Sub-Saharan Africa.

Emma Smith, Cecilia Milford, Kenneth Ngure, Sara Newmann, Nicholas B Thuo, Susana Berrios, Mags E Beksinska, Nelly Mugo, Larry Rand

Open access · goldAbstract read
In one paragraph

Article in Reproductive health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 49% of its field
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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
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

9 authors at 5 institutions in 3 countries.

Emma SmithDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
Cecilia MilfordMRU (MatCH Research Unit), Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa. cmilford@mru.ac.za.ORCID http://orcid.org/0000-0002-0026-7560
Kenneth NgureDepartment of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Sara NewmannDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
Nicholas B ThuoCenter for Clinical Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Susana BerriosUniversity of Illinois College of Medicine, Chicago, IL, USA.
Mags E BeksinskaMRU (MatCH Research Unit), Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.
Nelly MugoCenter for Clinical Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.
Larry RandDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
University of California, San Francisco · USKenya Medical Research Institute · KEUniversity of the Witwatersrand · ZAIllinois College · USJomo Kenyatta University of Agriculture and Technology · KE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrematurity and its complications are the leading cause of death and disability in children under five in Africa and North America, affecting as many as one in ten pregnancies. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. In parallel with early-stage U.S.-based testing of a novel self-placed intravaginal device to predict PTB risk, we elicited key stakeholder input from two sub-Saharan African countries to ensure local contextual factors inform future development of the device and its acceptability.

methodsA qualitative study was conducted in Kiambu County, Kenya and KwaZulu-Natal Province, South Africa. We conducted 26 focus group discussions with pregnant women (n = 132) and males from the community (n = 54); in-depth interviews with women who had a history of PTB (n = 10), healthcare providers (n = 16), and health system experts (n = 10). Interviews were transcribed and thematic analysis was performed using an iterative coding technique. In addition, we facilitated user-centered design sessions to generate prototype preferences.

resultsWomen with a personal history of PTB were almost unanimous in support of the proposed device, whereas those with no experience of PTB expressed the greatest degree of reservation. Healthcare providers anticipated that women with a history of PTB would accept the device. However, various potential challenges were identified, including potential discomfort with device insertion, hygiene, and sexual activity, as well as need for provider training, and attention to country-specific regulatory processes. Both community participants and providers expressed a preference for a provider inserted device. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal.

conclusionsUse of an intravaginal device to detect risk of PTB was generally acceptable, however stakeholders expressed a notable preference for insertion by providers. This reflects the significance of end-user consultation in device design and use. Recommended device modifications as well as educational messaging and provider technical assistance may facilitate utilization.

Indexed as

Obstetric Labor, PrematurePremature BirthChildFemaleHumansInfant, NewbornMalePregnancyPregnant PeopleSouth AfricaUser-Centered DesignMaternal healthMedical device developmentPreterm birthPreterm laborSub-Saharan Africa

Identifiers

PMID35907873
PMCPMC9338600
OpenAlexW4288748401

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.