PEMPS Study
Research type
Research Study
Full title
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
IRAS ID
356805
Contact name
J Ross
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Early pregnancy loss, including miscarriage, is a common event that can cause significant distress for women. Many women experiencing pain or bleeding in early pregnancy attend Early Pregnancy Units (EPUs) for ultrasound scans to assess the viability of their pregnancy. We have developed miscarriage prediction model, which uses routine ultrasound measurements and maternal factors to estimate the likelihood of pregnancy continuing when an embryo with a heartbeat is seen. However, it is not yet known how providing women with their miscarriage prediction score impacts their psychological well-being and if the score is acceptable to them.
This study aims to evaluate the psychological impact of a miscarriage prediction model that was previously developed using data from over 5,400 early pregnancies. The model relies on routine clinical information, such as ultrasound findings and maternal characteristics, to estimate the risk of miscarriage.
Participants in this study will be randomly assigned to one of two groups. One group will receive their miscarriage prediction score, while the other will receive standard care without the score. All participants will continue to receive usual clinical care, including follow-up ultrasounds where necessary.
We will assess whether receiving a miscarriage prediction score affects anxiety, depression, and overall psychological well-being, using validated questionnaires. Additionally, we will explore whether women find the prediction model useful and acceptable in their care.
By understanding the emotional impact of miscarriage prediction models, this study will help inform whether such tools should be incorporated into routine care in EPUs. If effective and beneficial, these models could improve support and counseling for women experiencing uncertainty in early pregnancy.
REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0710
Date of REC Opinion
13 Jan 2026
REC opinion
Further Information Favourable Opinion