Women’s experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study

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Abstract

Background

Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous women’s experiences of receiving an invitation to participate in a randomized controlled trial (RCT) of lateral episiotomy versus no episiotomy in vacuum-assisted delivery (EVA trial).

Methods

This qualitative study was nested in the ongoing EVA trial. Data were collected through semistructured telephone interviews with 23 women regarding their experiences of the information and invitation to participate in the EVA trial. Interviews were audio-recorded and transcribed verbatim. A qualitative content analysis was used to analyse the interview contents.

Results

Three main experience categories were identified among the participants. “Timing of trial information and understanding” revealed that women preferred to obtain information about the trial early on during pregnancy. “Reasons to consent to or decline participation in the trial” encompassed a variety of reasons for women to consent, such as goodwill for science or personal benefits, or to decline, such as not wanting to be randomized or fear of increased risk of having a vacuum-assisted delivery. “Thoughts evoked regarding childbirth” were diverse, ranging from not being affected at all to having increased anxiety.

Conclusions

The women’s experience of receiving an invitation to participate in an RCT of episiotomy in vacuum-assisted delivery varied widely, from immediately giving consent without further worries to increased anxiety or declining participation. Early and personal information with time for reflection was considered most satisfactory.

Trial registration

ClinicalTrials.gov NCT02643108. Registered on December 28, 2015. The Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women (EVA) trial was registered at www.clinicaltrials.gov.

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Most cited references 25

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The qualitative content analysis process.

Satu Elo, Helvi Kyngäs (2008)

This paper is a description of inductive and deductive content analysis. Content analysis is a method that may be used with either qualitative or quantitative data and in an inductive or deductive way. Qualitative content analysis is commonly used in nursing studies but little has been published on the analysis process and many research books generally only provide a short description of this method. When using content analysis, the aim was to build a model to describe the phenomenon in a conceptual form. Both inductive and deductive analysis processes are represented as three main phases: preparation, organizing and reporting. The preparation phase is similar in both approaches. The concepts are derived from the data in inductive content analysis. Deductive content analysis is used when the structure of analysis is operationalized on the basis of previous knowledge. Inductive content analysis is used in cases where there are no previous studies dealing with the phenomenon or when it is fragmented. A deductive approach is useful if the general aim was to test a previous theory in a different situation or to compare categories at different time periods.

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Thematic Analysis

Nancy Moules, Deborah White, Jill M Norris … (2017)

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A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

Ben G O Sully, Steven A Julious, Jon Nicholl … (2013)

Background Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded trials fail to reach their target sample size. This study seeks to assess the current state of recruitment success and grant extensions in trials funded by the Health Technology Assessment (HTA) program and the UK Medical Research Council (MRC). Methods Data were gathered from two sources: the National Institute for Health Research (NIHR) HTA Journal Archive and the MRC subset of the International Standard Randomised Controlled Trial Number (ISRCTN) register. A total of 440 trials recruiting between 2002 and 2008 were assessed for eligibility, of which 73 met the inclusion criteria. Where data were unavailable from the reports, members of the trial team were contacted to ensure completeness. Results Over half (55%) of trials recruited their originally specified target sample size, with over three-quarters (78%) recruiting 80% of their target. There was no evidence of this improving over the time of the assessment. Nearly half (45%) of trials received an extension of some kind. Those that did were no more likely to successfully recruit. Trials with 80% power were less likely to successfully recruit compared to studies with 90% power. Conclusions While recruitment appears to have improved since 1994 to 2002, publicly-funded trials in the UK still struggle to recruit to their target sample size, and both time and financial extensions are often requested. Strategies to cope with such problems should be more widely applied. It is recommended that where possible studies are planned with 90% power.

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Author and article information

Contributors

Jenny Ericson:

ORCID: http://orcid.org/0000-0002-3460-7500

jenny.ericson@regiondalarna.se

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 26 September 2021

Publication date PMC-release: 26 September 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 658

Affiliations

[1 ]GRID grid.411953.b, ISNI 0000 0001 0304 6002, School of Education, Health and Social Studies, , Dalarna University, ; Falun, Sweden

[2 ]GRID grid.8993.b, ISNI 0000 0004 1936 9457, Center for Clinical Research Dalarna, , Uppsala University, ; Falun, Sweden

[3 ]GRID grid.414744.6, ISNI 0000 0004 0624 1040, Department of Pediatrics, , Falu Hospital, ; Falun, Sweden

[4 ]GRID grid.414744.6, ISNI 0000 0004 0624 1040, Department of Gynecology and Obstetrics, , Falu Hospital, ; Falun, Sweden

[5 ]GRID grid.5640.7, ISNI 0000 0001 2162 9922, Department of Thematic Studies - Technology and Social Change, , Linköping University, ; Linköping, Sweden

[6 ]GRID grid.412154.7, ISNI 0000 0004 0636 5158, Department of Clinical Sciences, Karolinska Institutet, , Danderyd Hospital, ; Stockholm, Sweden

[7 ]GRID grid.8993.b, ISNI 0000 0004 1936 9457, Department of Women’s and Children’s Health, , Uppsala University, ; Uppsala, Sweden

Author information

Jenny Ericson http://orcid.org/0000-0002-3460-7500

Article

Publisher ID: 5624

DOI: 10.1186/s13063-021-05624-8

PMC ID: 8474868

PubMed ID: 34565424

SO-VID: 765b4019-a70b-4c13-97b6-a8428ca088be

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 21 October 2020

Date accepted : 14 September 2021

Funding

Funded by: Dalarna University

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: episiotomy,experiences,informed consent,randomized controlled trial,vacuum-assisted delivery

Data availability:

ScienceOpen disciplines: Medicine

Keywords: episiotomy, experiences, informed consent, randomized controlled trial, vacuum-assisted delivery

Women’s experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study

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Abstract

Background

Methods

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Conclusions

Trial registration

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Most cited references 25

The qualitative content analysis process.

Thematic Analysis

A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

Author and article information

Contributors

Journal

Affiliations

Author information

Article

History

Funding

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