IMPROVE V1.0
Research type
Research Study
Full title
Introduction of a new model for predicting early pregnancy outcome in women with initial pregnancy of uncertain viability: a Tablet App and psychological impact study.
IRAS ID
232277
Contact name
Kim Lawson
Contact email
Sponsor organisation
Chelsea and Westminster Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Intrauterine pregnancy of uncertain viability (IPUVI) affects 30% of women seen in the Early Pregnancy Unit (EPAU). Such women have a pregnancy within the uterus but no visible embryonic heartbeat on scan. The finding may represent a normally developing (but early) pregnancy (50%) but the remaining 50% of women go on to have a miscarriage. Following NICE Guideline 154(2012), women need a confirmatory ultrasound after two weeks. This interval is particularly distressing for women and diagnostic uncertainty in early pregnancy is associated with heightened levels of anxiety/depression. NICE Evidence Update 71(2014) suggested that provision of more information about the likely outcome of the pregnancy (prior to repeat ultrasound) may benefit psychological health.
IPUVI is a common problem causing anxiety for women and high resource requirements for follow-up ultrasound scans. We have previously developed, validated and published a mathematical model to predict pregnancy viability after diagnosis of IPUVI (1435 women studied). We now wish to use this to test the hypothesis that the adverse psychological effect of diagnostic uncertainty in early pregnancy can be modified in women who are given an individualised prediction of their pregnancy outcome.
Recruited participants in the EPAU at a single centre will be given an individualised prediction of their pregnancy outcome (using visual depiction on an App) at the time of diagnosis of IPUVI. The participants will be invited to complete anxiety symptom questionnaires at three defined points.
Although the prediction model cannot change pregnancy outcome, establishing that it is psychologically beneficial (and not harmful) may help up to 30% of the EPAU population. Furthermore, we plan to use the App to pilot a study identifying women at “low risk” for miscarriage in whom we can prevent unnecessary further scans, while “high risk” women would continue to be offered closer follow-up.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0362
Date of REC Opinion
2 Oct 2017
REC opinion
Unfavourable Opinion