Long-term health assessment of children following first trimester progesterone treatment in the PRISM trial (PRISM Follow-up)

The Data will be used for the purpose of a research project: Long-term health assessment of children following first trimester progesterone treatment in the PRISM trial (PRISM Follow-up).

The PRISM trial compared the health outcomes of children born to women who received progesterone during early pregnancy with those who were given a placebo. This study forms part of a follow-up to the PRISM trial (PROgesterone in early pregnancy bleeding).

The following is a summary of the aims of the PRISM Trial provided by the University of Birmingham:

- To compare the Health Utilities Index (HUI3) score between the progesterone and placebo groups.

- To compare the EQ-5D-y3L score between the progesterone and placebo groups.

- To compare the incidence of autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), dyslexia, dysgraphia, dyspraxia, dyscalculia, obsessive-compulsive disorder (OCD), anxiety, and depression between the progesterone and placebo groups.

University of Birmingham now want to contact participants regarding a follow-up study. To do this, they will be requesting NHS England (NHSE) Data to check the mortality status of the women and their child(ren) and confirm their most recent contact information. This is to mitigate the risk of attempts to contact women in inappropriate circumstances, for example, in the circumstance that they or their child(ren) have died.

Should the participant or child(ren) have died outside of the PRISM trial (and not otherwise known to the study team), follow-up communication would be upsetting. Use of the NHSE data will enable the study team to verify the mortality information of the participant and their child(ren) prior to contact by the study team. If, for any reason, the relevant information is unavailable and a change in the participant’s or their family’s circumstances comes to light, the Study Office will respond sensitively, ensure appropriate communication, and update the database to prevent any further contact.

The University of Birmingham will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth and a unique person ID) for the cohort to be linked with NHS England data.

NHSE will process the data provided by the University of Birmingham and use the Personal Demographics Service (PDS) data to identify deceased individuals, invalid records, and then generate a list of those who are contactable (mothers only). NHSE will then provide directly identifying details of the mothers who are contactable, including their names and full addresses. For mothers and children whose records are invalid and/or who are deceased, only the unique person ID will be provided.

The Data will not be transferred to any other location.

The Data will be stored on servers at the University of Birmingham.

The data will be backed up on a separate server at the University of Birmingham.

The Data will be accessed onsite at the premises of the University of Birmingham only.

The data will be used to update the follow-up PRISM database with a deceased marker where appropriate (alive/deceased). Contact details (name and full address) will be securely stored by the University of Birmingham on a separate server. Transfer of this information into the PRISM database will occur only if a response is received from the participant. In cases where no response is provided, all contact details will be securely destroyed within four months.

- An update to the PRISM participant database to verify the status of each mother and baby - identifying those who are deceased and therefore excluded from future follow-up and confirming those who are still living and can be contacted via their current postal address.

- The study sending a (re)consent package to the mother in order to ask for consent for the PRISM follow-up study. The consent covers both mother and child(ren) from the original PRISM consent.

The (re)consent packages will be sent to the relevant individual in question. For clarification, no clinical data is sent as an output but a consent package that asks the individual to consent on behalf of themselves and their child(ren).

The outputs will be communicated to relevant recipients through the following dissemination channels:

- A letter inviting participants to review the follow-up consent package regarding their, and their child's health, several years after receiving the progesterone treatment.

Collecting this data enables ongoing engagement with PRISM participants, contributing to a deeper understanding of the long-term health outcomes of children born to mothers who received progesterone treatment. At the same time, it ensures sensitivity by avoiding contact with participants who have passed away since recruitment.

Yielded Benefits is not a requirement for new applications.