Evidence map›Paper›PMID 34911726›Full record

ArticleBMJ open2021

Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England.

Emily J Hotton, Natalie S Blencowe, Erik Lenguerrand, Tim J Draycott, Joanna F Crofts, Julia Wade

Registry-linked trialAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06918509 (ASSIST Ethiopia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT06918509 nacompletednot on this mapstarted 2025, after this paper: background citation

ASSIST Ethiopia: Feasibility Clinical Investigation of Assisted Vaginal Birth With the Odonassist™ Medical Device

TypeinterventionalSponsorDoctors with Africa - CUAMMRan2025 to 2026Enrolled20ConditionsInstrumental Delivery, Medical Device, Feasibility Study, Acceptability StudyArmsOdonAssistTM
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

6 authors.

Emily J HottonTranslational Health Sciences, University of Bristol, Bristol, UK emily.hotton@nhs.net.ORCID 0000-0002-8570-9136
Natalie S BlencoweCentre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.ORCID 0000-0002-6111-2175
Erik LenguerrandTranslational Health Sciences, University of Bristol, Bristol, UK.
Tim J DraycottWomen's and Children's Research, North Bristol NHS Trust, Bristol, UK.
Joanna F CroftsWomen's and Children's Research, North Bristol NHS Trust, Bristol, UK.
Julia WadePopulation Health Sciences, Univeristy of Bristol, Bristol, UK.ORCID 0000-0001-6486-6477

Funding

Gates Foundation INV-010180Medical Research Council MR/S001751/1
6 · The paper itself

Abstract

objectiveTo investigate women's experiences of having a birth assisted by the Odon Device (an innovative device for assisted vaginal birth) and participation in intrapartum research.

designQualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study.

settingA tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019.

participantsEight women, four operators and 11 midwives participated with eight observations of the assisted vaginal birth, eight interviews with women in the postnatal period, 39 interviews/reflections with operators and 19 interviews with midwives. Women in the case study research were recruited from participants in the main ASSIST Study.

interventionThe Odon Device, an innovative device for assisted vaginal birth.

resultsThirty-nine case studies were undertaken. Triangulation of data sources (participant observation, interviews with women, operators and midwives) enabled the exploration of women's experiences of the Odon Device and recruitment in the intrapartum trial. Experiences were overwhelmingly positive. Women were motivated to take part by a wish for a kinder birth, and because they perceived both the recruitment and research processes (including observation) to be highly acceptable, regardless of whether the Odon-assisted birth was successful or not.

conclusionsInterviews and observations from multiple stakeholders enabled insight into women's experiences of an innovative device for assisted vaginal birth. Applying these qualitative methods more broadly may illuminate perspectives of key stakeholders in future intrapartum intervention research and beyond. TRIAL REGISTRATION NUMBER: ISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171.

Indexed as

Biomedical ResearchExtraction, ObstetricalPatient ParticipationEnglandFemaleHumansMidwiferyPregnancyQualitative ResearchState Medicinemedical education & trainingobstetricsqualitative research

Identifiers

PMID34911726
PMCPMC8679107

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Registered trials

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.