IMPROVE V3.0
Research type
Research Study
Full title
Implementation of a model for predicting early pregnancy outcome in women with initial pregnancy of uncertain viability: a 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, 1 days
Research summary
Intrauterine pregnancy of uncertain viability (IPUVI) affects 10-28% of women seen in the Early Pregnancy Unit (EPAU) setting. Such women have a pregnancy within the uterus but no visible embryonic heartbeat on scan. This finding may represent a normally developing (but early) pregnancy in 50% of affected women, but the remaining 50% go on to have a miscarriage. Following NICE Guideline 154(2012), women need a confirmatory ultrasound after two weeks. This 2-week interval between scans is a difficult time for patients. Studies have previously identified the negative impact on psychological health where early pregnancy complications arise. 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.
We have previously developed, validated and published a mathematical tool to predict pregnancy viability after diagnosis of IPUVI (549 women studied). We now wish to use this tool 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.
The study will recruit all eligible women with IPUVI through a single centre EPAU. Women will be randomised to one of two groups and asked to complete questionnaires related to symptoms of anxiety and emotional well-being at three defined time points during their care. Group I recruits will be randomised to receive the prediction tool. Group II will be randomised to not receive the prediction tool.
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.
REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/0550
Date of REC Opinion
18 May 2018
REC opinion
Further Information Favourable Opinion