We still don’t know enough about why some women experience multiple miscarriages. In addition, different hospitals have different standards of care for women who have had a miscarriage. For example, many couples will only be investigated after they have had three miscarriages. This system causes unimaginable, and unnecessary, pain for the women affected. Tommy’s Net is a database that will help us to collect and store information from hospitals and clinics, as well as access current medical records. This will allow the team to develop new methods to tell which women are at most risk of having a miscarriage.
We are also able to use this cohort of patients to test new treatments using a cohort multiple Randomised Controlled Trial (cmRCT) design. This is a relatively new trial design that simplifies the recruitment and conduct of trials compared with current RCTs. In this trial design, participants are asked to agree to participate in the control arm of any future trials that will be conducted by the research team.
Once a substantial cohort of participants has been established that have given their consent to participate in the cmRCT, one is able to conduct a trial by identifying and selecting a random sample of participants who will receive the intervention, and another group that will continue to receive standard care. Those patients that are allocated to the intervention will be invited to give their written, informed consent to participate in the intervention arm. However, those allocated to standard care (control arm), can continue to be followed up in the usual way with no additional contact required.
Relevant outcomes and other measures are taken on all patients in both arms as part of the regular follow-up process. A large benefit of this trial design is that the same cohort can be used for multiple interventions, so are large number of clinical trials can be conducted within the same core cohort of patients.
Project team
Contact details: bwh-tr.tommysclinic@nhs.net