Trial reportTrials2021
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.
Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02643108 (Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women), which is not on this map. Cited by 2 papers.
What it found
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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.
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.
Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women
Who cites it
2 citing papers in PubMed, 5 citations in OpenAlex.
- Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial.BMJ (Clinical research ed.) · 2024Trial
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformation 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).
methodsThis 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.
resultsThree 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.
conclusionsThe 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 registrationClinicalTrials.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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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.