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
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 randomiz...
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doaj-91529e0168ab489eaa3a4acc328a59442021-10-03T11:45:13ZengBMCTrials1745-62152021-09-012211710.1186/s13063-021-05624-8Women’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 studyJenny Ericson0Cecilia Anagrius1Agnes Rygaard2Lisa Guntram3Sophia Brismar Wendel4Susanne Hesselman5School of Education, Health and Social Studies, Dalarna UniversityDepartment of Gynecology and Obstetrics, Falu HospitalDepartment of Gynecology and Obstetrics, Falu HospitalDepartment of Thematic Studies - Technology and Social Change, Linköping UniversityDepartment of Clinical Sciences, Karolinska Institutet, Danderyd HospitalCenter for Clinical Research Dalarna, Uppsala UniversityAbstract 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 .https://doi.org/10.1186/s13063-021-05624-8EpisiotomyExperiencesInformed consentRandomized controlled trialVacuum-assisted delivery |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jenny Ericson Cecilia Anagrius Agnes Rygaard Lisa Guntram Sophia Brismar Wendel Susanne Hesselman |
spellingShingle |
Jenny Ericson Cecilia Anagrius Agnes Rygaard Lisa Guntram Sophia Brismar Wendel Susanne Hesselman 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 Trials Episiotomy Experiences Informed consent Randomized controlled trial Vacuum-assisted delivery |
author_facet |
Jenny Ericson Cecilia Anagrius Agnes Rygaard Lisa Guntram Sophia Brismar Wendel Susanne Hesselman |
author_sort |
Jenny Ericson |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-09-01 |
description |
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 . |
topic |
Episiotomy Experiences Informed consent Randomized controlled trial Vacuum-assisted delivery |
url |
https://doi.org/10.1186/s13063-021-05624-8 |
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