The psychological effects and patient acceptability of a test to predict viability in early pregnancy: a prospective randomised study

Objective: To establish if women obtain any measurable short term psychological benefit or perceived benefit from having a test to determine the probability of their pregnancy being on-going when this is uncertain on ultrasound examination. Study design: This was a prospective randomised controlled study conducted January 2012-June 2012 at the EPU of King's College Hospital. The study population was women who conceived spontaneously and had a single intrauterine gestational sac of <20 mm mean diameter, with no visible embryo on their first ultrasound scan. Eligible women were randomised to have a test to calculate the probability of viability (cases) or not (controls). Depression and anxiety levels were calculated using the Hospital Anxiety and Depression Score (HADS) and were performed prior to randomisation and seven days later. A repeat scan for pregnancy outcome was performed after one to two weeks as clinically indicated. A sample size of 69 in each group was calculated to have 80% power to detect a probability of 0.362 that an observation in the cases was less than an observation in controls using a Wilcoxon Mann-Whitney rank-sum test with a 0.05 two-sided significance. Results: At recruitment there was no significant difference in anxiety levels between cases and controls. After seven days anxiety levels were significantly lower in cases than controls (p = 0.04). Of those who received the probability score, 55/70 (78.6% 95% CI 67.5-86.7%) found it useful and 58/70(82.9% 95% CI 72.2-90.1) would choose to have the test in a future pregnancy if indicated. Conclusions: This study has demonstrated that there is evidence of psychological benefit from a simple blood test that gives women the likelihood that their pregnancy will be on-going at the next scan. (C) 2014 Elsevier Ireland Ltd. All rights reserved.