In accordance with the protocol at site set-up, all sites should:
- Provide the OptiBreech research team with a copy of your current guideline covering the management of breech presentation at term, including information provided to women.
- Provide us with materials used in mandatory training and any specialist site-specific training, or a brief description. For example, we are interested if your mandatory training uses an in-house package or is based on PROMPT or another training programme.
- Please answer: When a woman plans a vaginal breech birth, is it routine to put a plan in place to ensure she has experienced support at the birth, e.g. formal or informal on-call system? (Yes/No)
- Liaise with your research team to identify how you will deliver the anonymised data required in the protocol, outlined below.
- Make the OptiBreech training available to your staff members. The research team will provide further information on how to do this.
The data should cover all term singleton breech births (>37 weeks) occurring during the period beginning 2 years prior to the date of site opening. Thereafter, it should be returned monthly. We hope that this will be a fairly straightforward process once the electronic systems are set-up to download the data from your e-Health Records. If someone other than the PI will be providing this data (e.g. an audit or research midwife), please put the research team in touch with them.
Study Codes – to be maintained in site file only, in case of queries
- Site code
- Participant’s code, for use in case of queries
- Maternal NHS Number
- Maternal Hospital Medical Record Number
Anonymised cohort data to be obtained from electronic healthcare records
- Study participant (Yes / No)
- Study code
- Maternal parity
- Baby’s date of birth
- Gestation at birth (Weeks, days)
- ECV attempt? (Yes / No)
- Successful? (Yes / No)
- Planned mode of birth (Cephalic birth, vaginal breech birth, elective caesarean section)
- Actual mode of birth (Vaginal breech birth, instrumental breech delivery, elective caesarean section, emergency caesarean section, cephalic birth, cephalic instrumental delivery)
- Where birth occurred (OU, theatre, AMU, FMU, OOH)
- Maternal birth position (upright, supine, lateral, CS)
- Admission to neonatal unit? (Yes, No)
- Stillbirth or neonatal death (Yes, No)
The above information outlines the minimum required for sites who are participating in OptiBreech 1. For sites who are also intending to offer OptiBreech support for planned or unplanned breech births, these are the next steps.
- Invite your colleagues to express an interest in delivering OptiBreech care by completing the consent form and survey. This is linked from the top of the Information for Professionals page. (password is available from the protocol or research team)
- All staff members supporting OptiBreech births need to have completed the OptiBreech Training, also available from the Information for Professionals page. (password is available from the protocol or research team)
- On-line participant Information Sheets and Consent Forms are all linked from the Information for Women and Birthing People page. (password is available from the protocol or research team — the research team are happy to run through this process with you whenever you like, so do not hesitate to be in touch)
In this study, the following count as accruals:
- recruitment of women who are planning a vaginal breech birth with OptiBreech support;
- recruitment of women who have had an unplanned vaginal breech birth with support from the OptiBreech team;
- interviews with health care professionals who have been involved directly or indirectly with care for women recruited to the study.
Because of the importance of developing services slowly and carefully where vaginal breech births have been rare in the past couple of decades, we have enabled sites to access the enhanced training in exchange for anonymised, retrospective data only; however the return of this data will not count as an accrual. There is no minimum recruitment target, though we may seek to interview key staff about their feelings of readiness / willingness to support planned vaginal breech births or to develop a proficient team.