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\begin{document}

\title{Exploring the reporting standards of RCTs involving invasive procedures
for assisted vaginal birth: a systematic review}



\author[1]{Emily Hotton}%
\author[1]{Sophie Renwick}%
\author[2]{Erik Lenguerrand}%
\author[2]{Julia Wade}%
\author[1]{Tim Draycott}%
\author[1]{Joanna Crofts}%
\author[2]{Natalie Blencowe}%
\affil[1]{North Bristol NHS Trust}%
\affil[2]{University of Bristol}%


\vspace{-1em}



  
  \date{May 15, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Background Assisted vaginal birth (AVB) is a complex intervention
involving medical devices, comprising multiple components. This
complexity creates difficulties when designing and conducting randomised
controlled trials (RCTs), in terms of describing, standardising and
monitoring the intervention, and accounting for differing clinician
expertise. Objectives This review examines the reporting standards of
complex interventions involving a medical device, in the context of AVB
RCTs. Search Strategy Searches were undertaken from the start of
indexing to November 2018, and limited to RCTs, feasibility and pilot
studies including at least one device for AVB. Selection Criteria RCTs
were selected if they included participants having an AVB with any
device, with or without a comparator group. Data Collection and Analysis
Reporting details were assessed according to the Consolidating Standards
of Reporting Trials extension for non-pharmacological treatments
(CONSORT-NPT), focusing on intervention descriptions, standardisation,
adherence and clinician expertise. Main Results Of 2,510 abstracts and
74 full-text articles, 36 papers were included, investigating 73
interventions. Twenty-eight different named devices were identified.
Intervention descriptions were provided in 20(56\%) papers with varying
levels of detail and none covered the entire procedure. Standardisation
of interventions was mentioned in 23 papers (64\%). Only seven(19\%)
papers reported any form of adherence to the intended procedure. Some
data regarding expertise were reported in 23(64\%) papers. Conclusions
Despite some compliance with reporting standards, there is a lack of
detail regarding intervention description, standardisation, adherence
and expertise in RCTs of AVB. This creates difficulties in understanding
how intervention delivery was intended and what actua%
\end{abstract}%



\sloppy


\textbf{Exploring the reporting standards of RCTs involving invasive
procedures for assisted vaginal birth: a systematic review}

Emily J Hotton\textsuperscript{1,2 *}, Sophie
Renwick\textsuperscript{2}, Erik Lenguerrand\textsuperscript{1,2}, Julia
Wade\textsuperscript{3}, Tim J Draycott\textsuperscript{2}, Joanna F
Crofts\textsuperscript{2}, Natalie S Blencowe\textsuperscript{4,5}

\textsuperscript{1} Translational Health Sciences, University of
Bristol, Bristol, UK

\textsuperscript{2} Southmead Hospital, North Bristol NHS Trust,
Bristol, UK

\textsuperscript{3} Population Health Sciences, University of Bristol,
Bristol, UK

\textsuperscript{4} Centre for Surgical Research, Population Health
Sciences, University of Bristol, Bristol, UK

\textsuperscript{5} University Hospitals Bristol NHS Foundation Trust,
Bristol, UK

\textbf{* Corresponding Author:}

Women and Children's Academic Research

The Chiltern's

Maternity Unit

Southmead Hospital

Bristol

United Kingdom

BS10 5NB

Tel: 0117 414 6764

Email: emily.hotton@nhs.net

\textbf{Running title:} Reporting standards for AVB: a systematic review

\textbf{Abstract word count:} 250

\textbf{Word count:} 3460

\textbf{ABSTRACT}

\textbf{Background}

Assisted vaginal birth (AVB) is a complex intervention involving medical
devices, comprising multiple components. This complexity creates
difficulties when designing and conducting randomised controlled trials
(RCTs), in terms of describing, standardising and monitoring the
intervention, and accounting for differing clinician expertise.

\textbf{Objectives}

This review examines the reporting standards of complex interventions
involving a medical device, in the context of AVB RCTs.

\textbf{Search Strategy}

Searches were undertaken from the start of indexing to November 2018,
and limited to RCTs, feasibility and pilot studies including at least
one device for AVB.

\textbf{Selection Criteria}

RCTs were selected if they included participants having an AVB with any
device, with or without a comparator group.

\textbf{Data Collection and Analysis}

Reporting details were assessed according to the Consolidating Standards
of Reporting Trials extension for non-pharmacological treatments
(CONSORT-NPT), focusing on intervention descriptions, standardisation,
adherence and clinician expertise.

\textbf{Main Results}

Of 2,510 abstracts and 74 full-text articles, 36 papers were included,
investigating 73 interventions. Twenty-eight different named devices
were identified. Intervention descriptions were provided in 20(56\%)
papers with varying levels of detail and none covered the entire
procedure. Standardisation of interventions was mentioned in 23 papers
(64\%). Only seven(19\%) papers reported any form of adherence to the
intended procedure. Some data regarding expertise were reported in
23(64\%) papers.

\textbf{Conclusions}

Despite some compliance with reporting standards, there is a lack of
detail regarding intervention description, standardisation, adherence
and expertise in RCTs of AVB. This creates difficulties in understanding
how intervention delivery was intended and what actually occurred.
Clearer guidelines for the reporting of invasive procedures and devices
are required.

\textbf{Funding}

This study was supported by the Bill \& Melinda Gates Foundation
{[}grant number OPP1184825 / INV-010180{]}, the NIHR Biomedical Research
Centre at University Hospitals Bristol and Weston NHS Foundation Trust
and the University of Bristol. The views expressed are those of the
author(s) and not necessarily those of the NIHR or the Department of
Health and Social Care, and the MRC ConDuCT-II (Collaboration and
innovation for Difficult and Complex randomised controlled Trials In
Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1).

\textbf{Keywords}

Reporting standards; adherence; standardisation; complex interventions;
randomised controlled trials; assisted vaginal birth; ventouse; forceps;
Odon Device

\textbf{Tweetable abstract} : Reporting standards in assisted vaginal
birth RCTs lack detail \& transparency. Bespoke guidance for RCTs
involving devices may help address this problem

\textbf{INTRODUCTION}

Assisted vaginal birth (AVB) is an invasive procedure that, in skilled
hands, can markedly improve maternal and neonatal outcomes arising from
complications in the second stage of labour. Typically, AVB involves the
use of devices such as forceps or ventouse and, more recently, new
devices. Well-designed randomised controlled trials (RCTs) are essential
for assessing the effectiveness of invasive procedures such as AVB,
thereby enabling clinicians to make evidence-based decisions about
whether to introduce them in routine practice. Similarly, high-quality
reporting of RCTs is necessary to ensure that such procedures and
devices are adopted and implemented correctly. However, the design and
conduct of RCTs involving invasive procedures and devices (such as AVB)
can be challenging because of their complexity. Complex interventions
are defined as those with multiple interacting components that can act
independently or interdependently to influence outcomes. This complexity
can create difficulties in establishing how interventions should be
delivered (standardisation) and ascertaining whether they are actually
delivered as intended (adherence) within an RCT. Additional challenges
are that the delivery of complex interventions can be influenced by
clinicians' skill (expertise). There may also be repeated modifications
of new invasive procedures or devices during the developmental phase,
which may not be reported or accounted for in trial design, that may
influence trial outomes.

With accumulating numbers of reports citing complications associated
with new invasive procedures and devices, expert panels have suggested
that more rigorous clinical evaluation is required through improved RCT
design. The need for methodological rigour has also been acknowledged in
reporting guidance documents such as the Consolidating Standards of
Reporting Trials extension for non-pharmacological treatments
(CONSORT-NPT), which includes invasive procedures and devices such as
those used for AVB. CONSORT-NPT suggests that `precise details of the
experimental treatment', `details on whether and how the interventions
were standardised', `details of whether and how adherence of care
providers to the protocol was assessed', and `information about the
expertise of care providers' should all be described in trial reports.
As well as reducing bias and improving methodological quality, provision
of this information should help to contextualise trial findings, enable
successful interventions to be replicated in practice, and reduce
research waste.

The aim of this review was to assess the reporting standards in RCTs of
AVB according to CONSORT-NPT guidance, specifically focusing on
intervention description, standardisation, adherence and clinician
expertise.

\textbf{METHODS}

Full methods have been published previously and are summarised below.
Patient and public involvement was not sought for this systematic
review.

\textbf{Search strategy}

Searches of Medline, EMBASE, The Cochrane Library (Cochrane Database of
Systematic Reviews, Cochrane Central Register of Controlled Trials
(CENTRAL), Cochrane Methodology Register, Cumulative Index of Nursing
and Allied Health Literature (CINAHL) and ClinicalTrials.gov were
undertaken from the start of indexing to 30\textsuperscript{th} November
2018. Searches were limited to RCTs, feasibility and pilot studies
including at least one intervention or device used for AVB (Table S1).

\textbf{Inclusion of papers}

RCTs, pilot and feasibility studies (with or without a comparator group)
were included. Retrospective studies (e.g. case-control or cohort
studies) were excluded because CONSORT-NPT guidance focuses on reporting
standards in RCTs. Simulation and animal studies were included if they
otherwise met the inclusion criteria. There were no language
restrictions. AVB devices were not limited to a single type or
manufacturer. Any type of comparator was included (i.e. spontaneous
vaginal birth (SVB), Caesarean section or another AVB device).

After removal of duplicate records, titles and abstracts of citations
were screened for eligibility by two researchers (EJH and SR) using
predetermined selection criteria. Reference lists of retrieved articles
were manually searched for additional references, including published
protocols for included studies. Each abstract was independently read by
at least two authors and full-text articles meeting the inclusion
criteria analysed by at least two authors (EJH, SR or NSB).
Discrepancies were resolved by discussion with NSB.

\textbf{Data extraction}

Data were extracted in the following categories: general study
information, intervention description, standardisation, adherence, and
clinician expertise. The methodological quality of all included studies
was assessed. Where available, information from citations to protocols
or supporting material (such as pictures, videos or intervention
manuals) was used to supplement data extraction.

General study information

General study details including year of publication, study country of
origin, study design, the number of participating centres and the total
number of participants, were recorded.

Intervention description (CONSORT-NPT items 5 and 5a)

Reporting of details about the interventions was assessed by recording
verbatim descriptions of the operative components and steps of the
procedure (item 5a). A description was deemed to have been provided if
anything more than the name of the intervention or device was reported.
For example, a study reporting that `women had their birth assisted
using forceps' would not constitute a description, whereas information
about how to apply the device to the fetal head would be considered as a
description of the intervention. Although CONSORT-NPT requires `precise
details' of the intervention to be provided, this is not defined (item
5). Items 5 and 5a further stipulate the reporting of
the\emph{`sufficient details to allow replication'} and of
\emph{`different components of the intervention'.} We therefore defined
`precise details' of an intervention as provision of a description for
each component of an AVB: device application, creation of a vacuum
(ventouse only), device traction and device removal. Descriptions of
co-interventions (defined as `naturally accompanying or associated
elements to the intervention itself') such as provision of analgesia was
also recorded. Reporting of whether an intervention was described as
novel was also recorded to understand whether `new' interventions had
better reporting details.

Intervention standardisation (CONSORT-NPT item 5b)

Standardisation was defined as the process of making an intervention
conform to a standard (i.e. falling into an accepted range of quality).
Reporting of standardisation (of both interventions and
co-interventions) was assessed by recording i) specific details about
the criteria for using the device and ii) whether there was any
permitted flexibility in this standardisation, in terms of whether the
operative components or steps were described as mandatory, prohibited,
optional or flexible.

Intervention adherence (CONSORT-NPT item 5d)

Adherence was defined as the degree to which an intervention was
conducted according to the protocol or outlined by its designers. Any
reporting of adherence to intervention or co-interventions was recorded,
including details of how this was measured. Details about crossover from
one intervention group to another were also recorded.

Clinician expertise (CONSORT-NPT item 15)

Provision of information about clinician qualifications, grade, number
of AVBs previously undertaken (including those using the device under
evaluation) and total number of births annually in the unit, were
recorded. The number of clinicians undertaking AVBs in each trial group
was documented, including whether they performed AVBs within one or more
trial group. Information about study entry criteria for clinicians was
extracted (e.g. supervision, eligibility or completion of pre-study
training materials). Any descriptions or references to clinician
learning curves were extracted verbatim.

Study quality

The Cochrane Risk of Bias tool was used to evaluate bias in all included
RCTs. Non-randomised pilot and feasibility studies were assessed by
evaluating bias related to the process of trial recruitment,
documentation of protocol non-adherence, reporting of a primary outcome,
description of clear objectives and description of clear progression
criteria.

\textbf{Funding}

This study was supported by the Bill \& Melinda Gates Foundation
{[}grant number OPP1184825 / INV-010180{]}, the NIHR Biomedical Research
Centre at University Hospitals Bristol and Weston NHS Foundation Trust
and the University of Bristol. The views expressed are those of the
author(s) and not necessarily those of the NIHR or the Department of
Health and Social Care, and the MRC ConDuCT-II (Collaboration and
innovation for Difficult and Complex randomised controlled Trials In
Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1).

\textbf{RESULTS}

Titles and abstracts of 2510 articles were identified, 74 full text
papers obtained and 34 eligible papers finally included. Two additional
papers were identified from hand searching reference lists of included
studies (Figure 1).

Study design and details

The 36 articles included 35 RCTs and one pilot study, published between
1964 and 2018, across 21 different countries and included 8,285 births
from 8,285 women and 8,285 babies. Twenty-nine (81\%) were single-centre
studies. Details about the type of AVBs evaluated in the studies is
provided in Table 1. There were a total of 73 interventions and
comparators (36 device intervention groups, 33 device comparator groups
and four SVB comparator groups). Half of the papers (n=18, 50\%)
compared different types or techniques of ventouse devices. There were
no studies with a Caesarean section comparator group.

Twenty-nine papers (81\%) had two arms, each investigating a different
device. A further two papers had three arms (ventouse-ventouse-forceps
and ventouse-forceps-SVB). Four papers compared a device to SVB and the
final paper was a single arm pilot study investigating the Odon Device.

Two of the RCTs (6\%) referenced earlier preliminary work and two
further papers (6\%) referenced study protocols. One of these provided
further detail about adherence, but none provided additional information
about intervention descriptions, standardisation or expertise.

Intervention description (CONSORT-NPT items 5 and 5b)

Of the 69 device intervention and comparator groups across the 36
studies, specific device name(s) were provided in 61 (32 intervention,
29 comparator), within which there were different brands of forceps
(n=11), ventouse (n=16), and the Odon Device. The remaining eight stated
only that `forceps' (n=4) or `ventouse' (n=4) were used.

Two papers provided a single sentence related to device use but these
did not constitute intervention descriptions: \emph{`hospital guidelines
for instrumental delivery were followed for all patients\ldots{}'.} ,
`\emph{for outlet forceps deliveries, we used classic
instruments\ldots{}and standard techniques and classification\ldots{}'.}

Eighteen papers (50\%) provided some form of description of how to
deliver at least one of the interventions; all but two relating to the
ventouse. Descriptions were heterogeneous, with no papers providing
`precise details' for any included intervention. In terms of the
components, some description was provided for device application (n=2),
creating a vacuum (n=17), device traction (n=10) and no information was
provided about device removal (Table 2). No papers provided intervention
descriptions for forceps devices. The paper reporting on the Odon Device
provided both narrative and pictorial descriptions of how to use it
However, not all components were included and therefore the description
was not considered as precise. This paper was one of only three that
explicitly stated that the device or device technique was new. Of the
other two, one referenced previous work on the new device and another
provided detailed description of intervention delivery, discussing the
majority (but not all) of the components.

Co-interventions were described in six papers (17\%) and consisted of:
bladder care prior to device use (n=4), maternal position (n=2) and use
of analgesia (n=3) (Table 2).

Interventions standardisation (CONSORT-NPT item 5b)

Conditions for device use were reported in 35 papers (97\%) although in
21 (66\%) it was not clear whether these were the same across all study
arms.

Information about any mandatory, flexible and optional operative
components or steps was provided in 23 papers (64\%). All except three
related to ventouse, even when forceps were the intervention rather than
the comparator (Table 3). \emph{\textsuperscript{,}}

Seventeen papers (42\%) reported flexibility in the devices clinicians
were permitted to use, relating to the comparator group (n=12),
intervention (n=1) and both intervention and comparator (n=4). Five of
the papers described flexibility in the specific brand of device that
could be used, (ventouse = 4, forceps = 1), stating that the choice was
left to the clinician. In a further study, women were randomised by
clinician preference, `\emph{Decision for forceps delivery or ventouse
extraction was of consultant and the choice of method was dependent
entirely on his/her judgement'.}

Standardisation was also reported for co-interventions in 11 papers
(31\%) and related to the provision of analgesia (\emph{n} =4) and use
of episiotomy (\emph{n} =9) (Table 2).

Intervention adherence (CONSORT-NPT item 5d)

Seven papers (19\%) reported any form of adherence to the intended
procedure. Of these, six stated that procedural details were documented
by the clinician after the assisted birth; however, it was unclear
whether this information related to details of how the procedure was
undertaken or to maternal and neonatal outcomes following birth. One
paper provided further information: \selectlanguage{ngerman}\emph{`participants in the first
phase were asked for written consent to {[}video{]} tape the application
of the Odón device. These tapes were made available to the DSMB for
safety evaluation purposes.'} However, no clarification was provided
about who analysed the videos and the standards to which they were
assessed.

Of the 35 papers with more than one trial group, 24 (69\%) stated the
number of women crossing over to another group. In a further eight
(23\%), it was unclear whether crossovers had occurred and in the
remaining three (9\%) there was no mention of crossovers.

Clinician expertise (CONSORT-NPT item 15)

Some data were provided about the expertise of clinicians performing AVB
in 23 papers (64\%). None of the papers explicitly outlined the
clinicians' qualifications although their grade was reported in 22
papers (61\%). One paper stated that `\emph{trained registrars or
specialist obstetricians performed all deliveries'} but there was no
clarification of the nature of this training. A further paper reported
the number of AVBs previously undertaken by each clinician and grouped
them according to whether they had performed fewer or greater than 20
procedures however, it was not clear if they used the intervention or
comparator to determine the grouping. Only eight papers (22\%) reported
the number of AVB performed per year in the trial centres. Although 15
(42\%) reported the number of clinicians performing AVB in the study,
none explicitly stated that the same clinicians performed interventions
across all trial arms.

Descriptions of the supervision of clinicians was provided in eight
papers (22\%); in the majority (\emph{n=} 7) this referred to trainees
being supported by senior clinicians. The one pilot study stated
that\emph{`all applications of the device were supervised, and assisted
as required, by another obstetrician trained in the use of the device'}
but did not specify what this training entailed. Clinician eligibility
criteria was mentioned in two papers (6\%) \emph{`obstetric registrars
(year 2 to year 4) trained in the use of the vacuum extractor' and `each
operator was classified according to prior experience with each
instrument {[}vacuum extractor and forceps{]}'.} None of the papers
required clinicians to have completed a certain number of AVBs prior to
joining the study. Some information about pre-study training was
reported in three papers (8\%): \emph{`opportunity to watch a training
video'} , \emph{`\ldots{}verbal and written advice' and
`\ldots{}instructed in the use of both methods\ldots{}'} . An additional
paper clarified that \emph{`clinicians had no specific training in the
use of the disposable cup before the trial'} despite the authors
acknowledging that this was a new device.

Eight papers (22\%) made reference to clinicians' learning curve, two of
which were in relation to devices that were described as new. Of these
eight studies, two accounted for the learning curve by comparing event
rates across two time periods. The remaining six papers acknowledged
that the learning curve may impact on study findings but did not adjust
for this.

Assessment of study quality

The majority of studies were judged to be `unclear' across all domains
of bias except `random sequence generation and allocation concealment'
which had equal `unclear' and `low-risk' judgements (Table S2).

\textbf{DISCUSSION}

Main Findings

This systematic review summarised reporting standards of AVB in RCTs.
Although the majority of the interventions or comparators were named,
only half of the studies provided any description of how the
interventions should be delivered and none were considered to be
`precise'. The majority of papers did not discuss intervention
standardisation, focusing instead on criteria for device use (such as
gestation or presentation of baby) rather than how the device should be
used. Information regarding adherence was similarly poorly reported.
Two-thirds of papers provided data regarding clinician expertise;
however, this often was not detailed or specific. The overall lack of
detail in the studies makes it hard to know exactly how procedures were
intended to be performed and actually delivered, creating difficulties
in interpreting results or replicating procedures in routine clinical
practice.

Although this is the first study exploring reporting standards in RCTs
of interventions for AVB, there have been several similar systematic
reviews in RCTs of other invasive procedures (e.g. surgery).
Predominantly, these concluded that reporting standards were poor and
surmised that this could be related to both a lack of uptake of
CONSORT-NPT and a degree of ambiguity in the language used to define
descriptions, standardisation and adhernece. It was particularly noted
that despite provision of some intervention descriptions, they were
often ambiguous and descriptions of all operative components were rarely
included. Moreover, it may not always be practical or desirable to
provide `precise' details of intervention delivery. In a multicentre
pragmatic trial, for example, it may be very difficult to achieve
standardisation of every procedural component and step, and this is
unlikely to reflect the heterogeneity of routine clinical practice. In
reality, there may need to be a reasonable compromise between the level
of detail and the flexibility permitted during procedural components, as
complex interventions are influenced by patient, operator, device and
centre-specific factors that may alter the way in which interventions
can be delivered.

Strengths and Limitations

This review is the first published report detailing reporting standards
relating to intervention description, standardisation, adherence and
expertise in AVB trials. The search strategy was wide and RCTs with a
non-device comparator arm were also included. The review therefore
provides a detailed inspection of reporting standards to provide an
informative narrative to explain the reporting quality. Despite this,
however, there are limitations. We only retrieved protocols or
associated documents from authors specifically mentioning or referencing
these within the trial report, so some may have been missed.
Additionally, the majority of papers lacked methodological robustness,
making it hard to relate positive findings to the wider research
community. Finally, only eight papers were published after the release
of the CONSORT-NPT guidelines in 2008. This is a key limitation as we
were comparing papers to standards that were not available to the
majority of authors at the time of publication. The present review
however does highlight that the poor quality of reporting standards is
constant, with no noticeable overall change in reporting quality since
the introduction of these guidelines. The reasons for the lack of
guideline adoption is likely to be multifactorial, relating to unclear,
non-specific definitions and instructions, a lack of awareness amongst
clinicians and trialists, and the lack of specificity of these
guidelines towards interventions involving the use of devices.

Interpretation

This review has highlighted the need for greater effort in the way
devices are described, standardised and monitored in trial reports for
AVB studies. This is likely to be the case for any device RCT, across
all specialties. Trial protocols and reports should have greater
consideration of the required details so that device use standards are
clear enabling replication in routine practice.

\textbf{Conclusion}

This paper presents a methodological review of reporting standards
relating to intervention description, standardisation, adherence and
expertise for RCTs in AVB, comparing them with CONSORT-NPT guidance.
Reporting standards in AVB trials are currently vague, lack
transparency, detail and clarity, especially surrounding adherence.
Although tools such as the CONSORT-NPT guidance attempt to address this
issue, consideration of the details required specifically for
interventions involving the use of devices is required. Such tools need
to provide unambiguous and accessible detail by providing definitions of
the key terms, such as standardisation and adherence. Bespoke guidance
for RCTs involving devices may help address this problem by describing
and defining standards for trialists and clinicians, to improve
methodological standards, facilitate replication of successful
interventions in clinical practice, and reduce research waste.

\textbf{Disclosure of Interests}

EJH, SR, JFC, TJD are employees of North Bristol NHS Trust, which
receives funding from PROMPT Maternity Foundation (PMF) to pay part of
their salaries. PMF has received funds from Becton Dickinson,
manufacturer of the Odon Device to run simulation studies on the device.
EL is an employee of the University of Bristol, which receives funding
from PMF to pay part of EL's salary. NSB is an MRC Clinician Scientist.

\textbf{Contribution to Authorship}

EJH and NSB initiated and designed the study with methodological input
from EL, JW, TJD and JFC. EJH, SR and NSB undertook data collection. EJH
and NSB drafted the manuscript. All authors approved the final version
of the manuscript.

\textbf{Details of Ethics Approval}

Not applicable.

\textbf{Funding statement}

This study was supported by the Bill \& Melinda Gates Foundation
{[}grant number OPP1184825 / INV-010180{]}, the NIHR Biomedical Research
Centre at University Hospitals Bristol and Weston NHS Foundation Trust
and the University of Bristol. The views expressed are those of the
author(s) and not necessarily those of the NIHR or the Department of
Health and Social Care, and the MRC ConDuCT-II (Collaboration and
innovation for Difficult and Complex randomised controlled Trials In
Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1).

\textbf{REFERENCES}

Table/Figure Caption List

Figure 1 Flow diagram of papers throughout the systematic review,
according to PRISMA criteria

Table 1 Intervention descriptions relating to the use of ventouse, by
component

Table 2 Descriptions and standardisation of the co-interventions

Table 3 Details of device use standardisation for ventouse interventions

\selectlanguage{english}
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