Development of a Pregnancy Register in the CPRD Aurum database.

Study type
Protocol
Date of Approval
Study reference ID
21_000373
Lay Summary

Electronic Health Record Databases such as the Clinical Practice Research Datalink (CPRD) play an important role in post market safety monitoring of drugs and vaccines given in pregnancy. However, it can often be difficult to pinpoint the start and end of a woman’s pregnancy in such data. Registers such as the CPRD/LSHTM GOLD Pregnancy Register offer a useful tool to make studies looking at pregnancy easier for researchers. Currently no equivalent register exists in the CPRD Aurum database which is larger than CPRD GOLD and has more currently contributing patients. This study aims to ascertain all sources of pregnancy data in the CPRD Aurum database and apply the same algorithm rules used to generate the CPRD GOLD register to this data, adapted where necessary to accommodate changes in data structure. The resulting Pregnancy Register will be compared to evidence of pregnancy in the linked Hospital Episode Statistics data. When the Mother Baby Link for CPRD Aurum becomes available we will also consider evidence in the linked baby’s record as evidence of pregnancy in the woman.
The register will also be compared to the existing CPRD GOLD Pregnancy Register by measures such as distribution of pregnancy outcome type, rate of pregnancies by calendar year, and mean length of pregnancy episodes. The CPRD Aurum Pregnancy Register will be made available to users of CPRD data wishing to study pregnancy. The larger size of the data will make it easier for researchers to look at new or rare exposures.

Technical Summary

Primary care electronic health records such as the Clinical Practice Research Datalink (CPRD) GOLD and Aurum provide an excellent resource for post market safety monitoring drugs and vaccines given in pregnancy. However, ascertaining exposure status and timing is challenging. The CPRD/LSHTM GOLD pregnancy register is an extremely useful tool for researchers wishing to study pregnancy. It provides a list of all pregnancies in the database, including details such as start and end dates, trimester dates and outcome. However, there is currently no equivalent register in CPRD Aurum.
This study aims to generate a pregnancy register in CPRD Aurum . We will ascertain and characterise all sources of pregnancy data in CPRD Aurum, and adapt the algorithm used to generate the CPRD GOLD pregnancy register to create a system-agnostic version of the algorithm. We will apply the algorithm to the CPRD Aurum data to try to generate a register of all pregnancies within the database.
The resulting register will be validated at the patient level, using pregnancy records in Hospital Episode Statistics Admitted Patient Care data (HES APC). We will establish concordance between the timing of these records and those in the primary care CPRD Aurum Pregnancy Register. When the Mother Baby Link for CPRD Aurum becomes available we will also consider evidence in the linked baby’s record as evidence of pregnancy in the woman. We will compare the resulting CPRD Aurum pregnancy register to the CPRD GOLD pregnancy register, and examine the distribution of outcome types, rate of pregnancies by calendar year and age, number of pregnancy episodes per woman and the mean length of pregnancy episodes. The CPRD Aurum register will be made available to CPRD users making it easier for researchers to study new and rare pregnancy exposures in CPRD data.

Health Outcomes to be Measured

Pregnancies and their associated outcomes in CPRD Aurum.

Collaborators

Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Hilary Shepherd - Collaborator - CPRD
Jessie Oyinlola - Collaborator - CPRD
Namir Oues - Collaborator - CPRD
Rhys Barnett - Collaborator - CPRD
Stephen Welburn - Collaborator - CPRD

Linkages

CPRD Mother-Baby Link;HES Admitted Patient Care;Pregnancy Register