Evidence map›Paper›PMID 42881416›Full record

Trial reportTrials2026

Considering the timing and appropriateness of trial consent during childbirth: a secondary analysis from the qualitative process evaluation of the ROTATE trial.

Eleanor Molloy, Jacqueline Nicholls, Dawn Parris, Rachel Plachinkski, Dimitrios Siassakos, Laura Jones, ROTATE Trial Group

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Eleanor MolloySchool of Health Sciences, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK. e.molloy@bham.ac.uk.ORCID http://orcid.org/0000-0002-4380-1006
Jacqueline NichollsEGA Institute for Women's Health, University College London, London, UK.
Dawn ParrisEGA Institute for Women's Health, University College London, London, UK.
Rachel PlachinkskiPatient and Public Contributor, NCT (National Childbirth Trust), Bristol, UK.
Dimitrios SiassakosEGA Institute for Women's Health, University College London, London, UK.
Laura JonesSchool of Health Sciences, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
ROTATE Trial Group

Funding

Health Technology Assessment Programme NIHR127818
6 · The paper itself

Abstract

backgroundThe ROTATE trial is a multi-centre randomised controlled trial of manual versus instrumental rotation of the fetal head in malposition at birth, to evaluate if manual compared with instrumental rotation reduces the risk of severe maternal perineal trauma, without increasing caesarean birth rates. ROTATE internal pilot phase ran from June 2022 to June 2023 with an embedded qualitative process evaluation (QPE). The QPE aimed to explore the feasibility, acceptability, and appropriateness of the trial for parents and healthcare professionals (HCPs). ROTATE had a two-stage consent process where verbal assent was sought prior to randomisation, and written consent was gained and recorded after the birth. This paper reports a secondary analysis of ROTATE QPE data focusing on gaining informed consent to trial entry in time-pressured maternity settings.

methodsSecondary analysis of data from semi-structured interviews with women (n = 9), their birth partners (n = 3), and HCPs (n = 11). Data were analysed using codebook thematic analysis.

resultsParents and HCP reported that offering a clinical trial at late-stage labour added additional complexities and challenges at a time-pressured period of their labour and birth. Using a layered approach to trial offering, where the trial information was shared prior to full eligibility, and discussed with multiple trusted HCPs, meant clinical trial approaches in late-stage labour can be anticipated. HCPs were concerned whether parents would recall conversations and decision-making about trial entry when they had been under physical and psychological stress in the second stage of labour. The two-stage consent process for ROTATE, using pre-randomisation verbal assent, with post-randomisation and post-birth written consent was considered acceptable to parents and pragmatic for HCPs delivering the trial. Gaining subsequent written consent, combined with appropriate birth partner support at the time of trial approach, was considered supportive of autonomous decision-making for women/birthing parents.

conclusionsClinical trial approaches in time-pressured maternity settings may be ethically challenging and add additional complexities at an already stressful time. A two-stage consent process, and early, layered information about the potential for participation in intrapartum clinical trials, supported informed consent and autonomous decision-making for women/birthing parents.

trial registrationISRCTN10193017. Registered on 24 November 2022.

Indexed as

Informed ConsentParturitionVersion, FetalAdultFeasibility StudiesFemaleHumansPregnancyQualitative ResearchTime FactorsChallenging clinical trialsInformed consentMaternity careMaternity settingsPilot trialQualitative process evaluationVerbal consentWritten consent

Identifiers

PMID42881416

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.