Introduction Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study.
Methods and analysis Relevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed.
Ethics and dissemination Ethical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.
- assisted vaginal birth
- complex interventions
- intervention standardisation
- intervention fidelity
- randomised controlled trials
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Contributors EJH and NSB initiated and designed the study with methodology inputs from EL, JW, TD and JFC. EJH and SR performed the data collection. KB performed database searches. EJH and NSB drafted the manuscript with inputs from SR, KB, EL, JW and JFC. All authors contributed to revisions of the manuscript and approved the final version.
Funding This work was supported by the Bill & Melinda Gates Foundation [grant number OPP1184825]. EJH, SR, JFC and TD are employees of the North Bristol NHS Trust, which receives funding from PROMPT Maternity Foundation (PMF) to pay part of their salaries. PMF has received funds from BD, manufacturer of the Odon 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 NIHR Clinical Lecturer. This study is being supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol, 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).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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