Second trimester loss: Estimating rates and understanding inequalities in loss - a retrospective cohort study in the CPRD database

Study type
Protocol
Date of Approval
Study reference ID
22_002359
Lay Summary

The loss of a baby between 13 and 23 weeks of pregnancy, often referred to as a second trimester, can be a devastating experience for parents with major effects on their health and well-being.
The number of families experiencing second trimester loss every year in the UK is not known as babies born showing no signs of life before 24 weeks of pregnancy are not officially registered. Research has emphasised parents “deserve recognition of their loss and reassurance that an accurate record of it will add to the global knowledge required to prevent future ones”. In the UK, high quality detailed data are available on registered stillbirths (loss from 24 weeks of pregnancy) and neonatal deaths, allowing robust monitoring of trends and targeted interventions. In comparison the lack of reliable robust national data on even the number of second trimester losses is surprising and extremely concerning. Limited regional research suggests 5,000-8,000 families experience second trimester losses every year in the UK (either spontaneously or following termination of pregnancy for fetal anomaly), up to three times the number of families experiencing stillbirth. Monitoring these second trimester losses is crucial for improving care in the future.
This study aims to assess the rate of pregnancies ending in second trimester loss, and find possible associations with sociodemographic factors such as socioeconomic deprivation and ethnicity. These findings will provide vital information on the number of people experiencing second trimester loss and related factors, since existing evidence in the UK is extremely limited.

Technical Summary

Second trimester pregnancy loss (13 to 23 weeks gestation) has major psychological and social impacts on parents. The absence of registration means second trimester losses go uncounted and unmonitored. Limited regional research from across several countries suggests up to three times the number of families experiencing second trimester loss compared to stillbirth. Monitoring loss is crucial for policymakers to improve perinatal outcomes.
This study aims to estimate the proportion of pregnant women who experience second trimester loss either spontaneously or following termination of pregnancy for fetal anomaly, and identify the potential key sociodemographic factors that have an impact on these rates. The cohort will include all people aged 11-49 who are pregnant from 13 weeks gestation between 01/01/2000 and 31/12/2021 identified using the CPRD Pregnancy Register based on CPRD GOLD and CPRD Aurum. This cohort will be divided into index cases who experience second trimester loss (a loss at 13 to 23 weeks of gestation) and those with a continuing pregnancy. Index cases will be the first pregnancy during the follow-up period and classified as a continuing pregnancy or a second trimester loss. Sociodemographic factors will be extracted based on the information available within CPRD-HES data. Using the CPRD Pregnancy Register and linked-primary secondary care data (HES) will offer detailed information on second trimester losses in this cohort. Evaluation of estimated rates of loss and sociodemographic factors associated with them will then be evaluated in our cohort using CPRD. This study will provide new evidence about second trimester loss and the sociodemographic factors associated with these rates. This will aid policymakers to improve perinatal outcomes by monitoring rates of loss and assessing sociodemographic inequalities to target care in the future.

Health Outcomes to be Measured

• Rate of pregnancies ending in second trimester loss (spontaneous or following termination of pregnancy for fetal anomaly) and trends over time
• Type of care provision for second trimester loss
• Association of second trimester loss with possible sociodemographic determinants such as maternal age, ethnicity, smoking status, alcohol intake, deprivation index, body mass index (BMI), and geographic area.

Collaborators

Lucy Smith - Chief Investigator - University of Leicester
Lucy Smith - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Elpida Vounzoulaki - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Megan McGovern - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of Leicester

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;CCG Pseudonyms;CPRD Aurum Pregnancy Register;CPRD GOLD Pregnancy Register