Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial.

OBJECTIVE

To investigate whether psychological wellbeing of women with an intrauterine pregnancy of uncertain viability can be modified during the waiting period to final diagnosis, by offering predictive information regarding the likely outcome of the pregnancy (chance of ongoing viability).

METHODS

This was a single-center two-arm randomized controlled trial conducted over 18 months at a teaching hospital in London, UK. Consecutive eligible women attending the early pregnancy assessment unit with an interim ultrasound finding of intrauterine pregnancy of uncertain viability were recruited. All women were offered a follow-up ultrasound scan after 14 days. Participants were randomized to receive a prediction score for ongoing viability at 14 days or routine care (control). Anxiety, depression and worry symptoms were assessed using validated self-report questionnaires (hospital anxiety and depression scale (HADS), Penn state worry questionnaire (PSWQ)) prior to randomization and at two further timepoints during the waiting period preceding final diagnosis. The change in psychological scores over the study period was analyzed. The secondary outcome was the perceived value of the risk prediction tool reported by participants.

RESULTS

A total of 278 women participated in this study. After adjusting for baseline scores, no difference in anxiety, depression or worry scores was demonstrated between control and intervention groups at either timepoint. Subgroup analysis, first of women with high initial anxiety (HADS > 11) or worry (PSWQ ≥ 45), and second of women with a more favorable predicted prognosis (≥ 75% chance of ongoing viability), demonstrated no difference between intervention and control groups. Despite this, 76/110 (69.1% (95% CI, 60.5-78.4%)) women who provided feedback in the intervention group found it to be helpful and 97/110 (88.2% (95% CI, 81.0-93.7%)) reported that they would use the tool again.

CONCLUSION

Current prediction tools may be useful for healthcare professionals to guide management and optimize utilization of early pregnancy resources. However, in this study, implementation of an accurate tool did not result in an objective measurable benefit to patients in terms of reduction in anxiety, depression and worry symptoms experienced during the waiting period to final outcome compared with women who did not receive a prediction score. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.