The feasibility of team care for women seeking to plan a vaginal breech birth (OptiBreech 1): an observational implementation feasibility study in preparation for a pilot trial

Abstract

Background OptiBreech Care is a care pathway for breech presentation at term, including where chosen, physiological breech birth attended by professionals with advanced training and/or proficiency. We aimed to assess the feasibility of implementing OptiBreech team care prior to proceeding with a planned pilot randomised controlled trial. Methods Our design was an observational implementation feasibility assessment across England and Wales, January 2021–June 2022. Our objectives were to determine whether Trusts could provide attendants with advanced training (implementation feasibility), who deliver protocol-consistent care (fidelity), within existing resources (costs), while maintaining low neonatal admission rates (safety) and adequate recruitment rates (trial feasibility). Participants included women > 37 weeks pregnant with a breech-presenting foetus, requesting support for a vaginal breech birth following standard counselling, and staff involved in the study. No randomisation occurred in this first stage of feasibility work. Results Thirteen National Health Service sites were recruited. A total of 82 women planned births in the study. Sites with a breech specialist midwife recruited at double the rate of sites without (0.90/month, 95% CI 0.64–1.16 vs 0.40, 95% CI 0.12–0.68). Referrals into the study came from midwives (46%), obstetricians (34%) and women themselves (20%). Vaginal births were attended by staff with OptiBreech training at 87.5% (35/40, 95% CI 0.732–0.958) and by staff who met additional proficiency criteria at 67.5% (27/40, 95% CI 0.509–0.814). Fidelity criteria were more consistently met by staff who also met proficiency criteria. There were four neonatal admissions (4.9%, 4/82), including one serious adverse outcome (1.2%, 1/82). Conclusions A prospective observational cohort of OptiBreech collaborative care, which could potentially support nested or cluster randomisation, appears feasible in sites willing to establish a dedicated clinic and strategically develop further proficient members of staff, with back-up plans for supporting rapidly progressing births. Randomisation procedures remain to be feasibility tested. It is funded by the NIHR (NIHR300582).

Authors’ reply

“…Across three studies, one serious adverse neonatal outcome has been reported (0.5%). [3][4][5] This is very near to the rate of adverse outcomes observed among low-risk women planning cephalic (head-first) births in the UK. Neonatal admission rates have been below 5%, similar to rates for all term births in the UK.…”

“…The complex intervention being tested, OptiBreech collaborative care, has been built up from over a decade's worth of research into howin the current conditions you describepractitioners acquire VBB skill and experience. [3][4][5] As you say, the conditions that (arguably) enabled this in the past are now non-existent. Different times call for different thinking and different strategies.…”

How safe is it to plan a vaginal breech birth with OptiBreech collaborative care?: analysis of cumulative data within the OptiBreech Multiple Trials Cohort

“…The second evaluated the feasibility of implementing Opti-Breech collaborative team care for planned VBBs 18 . In this study, among 82 planned VBBs, one serious adverse outcome (same composite, 1.2%) occurred.…”

“…We feel our results so far are due to strong qualitative work to develop the programme theory for the OptiBreech collaborative care model. Our logic model was developed and refined through: frequent and meaningful PPIE activities; systematic reviews to establish background, questions and women's experiences 8,22,33 ; Delphi consensus methods, including clinicians and service users, on core competencies and important outcomes 4,16,24,25,34 ; grounded theory methods to describe how clinicians learn breech skills 2,3 ; feasibility work to prepare for a substantive clinical trial 1,18 ; and a pilot randomised trial 28 .…”

“…Due to substantial differences in clinical practices and the way services are delivered, OptiBreech care is expected to result in different safety outcomes from standard care. The current logic model and TIDieR checklist 17 for OptiBreech collaborative care have been reported in previous publications 1,18 . The OptiBreech training package has been described in detail in evaluation publications 14,15 .…”