To ensure the feasibility of a large multi–centred trial, the SEE U trial will assess various aspects of the trial design, management and attrition rates. Although it will not be able to determine the relative effectiveness of intraoperative ultrasound during surgical removal of products of conception from the results, it will provide great insight for a larger powered trial in the future.
Trial design: A prospective, pilot, two arm, multicentre, randomised, open clinical trial.
Setting: Early pregnancy units and gynaecology departments.
Participant Population and Sample Size: Women aged 16 years or over that are referred for surgical management of miscarriage. The required sample size is 90 patients (30 participants recruited from at least 3 sites)
Intervention: Surgical evacuation of products of conception with intraoperative ultrasonography, compared to surgical evacuation of products of conception without intraoperative ultrasonography (standard care).
Duration of recruitment: 1 year
Randomisation: Randomisation will be provided by a secure online randomisation system developed by Birmingham Clinical Trials Unit (BCTU), accessible to recruiting staff at each trial site. Participants will be randomised at the level of the individual in a 1:1 ratio between the two arms. A “minimisation” procedure using a computer-based algorithm will be used to avoid chance imbalances in the following variables: Proposed anaesthesia type (none/local vs general) and randomising site.