We are in the process of developing the protocol and study materials for Stage 2 of the OptiBreech study which will be a multi-centre prospective observational cohort study designed to support multiple trials of care for women with a breech pregnancy at term.
In the next phase of our study, we will begin to record outcomes for breech pregnancies and births from several more hospitals across England, Wales and Scotland, on a large database. Personal information, such as names and NHS numbers, will be kept separately from information on the outcomes of pregnancies, so that those who participate are not identified by anyone looking at the data. We will need to collect a lot of data and store it for a long time, so it’s important we get this right. We want to ensure we are providing information about the study in a way that is clear and ethical.
OptiBreech 2 will involve randomly allocating women to different care pathways, and creating a large scale database of term breech pregnancies for the purposes of 1) establishing safety outcomes in real-world settings and 2) conducting multiple nested trials to establish effectiveness of interventions in the breech care pathway.
Also, we will be asking some women to allow us to assign them by chance to one treatment or another; this is called ‘randomisation.’ Assigning people by chance enables us to be sure that any differences we see in outcomes are due to the treatment and not something else. For this reason, evidence obtained following random assignment is considered the highest quality evidence. We would like to know how you feel about this and how we are proposing to do it.
We would like to hear your views on the acceptability of randomisation as well as on the Participant information sheet and Consent forms (linked below).
We’ve created a Participant Information Sheet, with information about the study, and a Consent form, which we would need each participant to sign. We would like to ensure these are clear. And we invite you to tell us if you think we should be doing something differently.
The meeting will be held on Wednesday 16th June, 11:00–12:00 via Microsoft Teams.
We hope to see you there!
The OptiBreech Project 