Surgical Evacuation with intraopErative Ultrasound: a pilot trial to assess feasibility
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Aim: To test the premise that intraoperative ultrasound can reduce the incidence of early and late complications following surgical removal of products of conception.
To obtain estimates for important aspects of the protocol to allow development of a substantive trial, specifically:
1. To derive real-time data on the design aspects of the study:
I. Proportion of eligible women of those screened.
II. Proportion of eligible women randomised.
III. Attrition rates (proportion of women followed-up at 2 to 4 and 4 to 8 weeks)
IV. Proportion of women switching treatments.
2. To derive a realistic understanding of trial processes, in particular:
I. Ascertain robustness of the data collection process during and after the surgical procedure.
II. Determine the support required in units to ensure successful recruitment.
III. Determine why patients decline participation or withdraw after randomisation.
Primary clinical outcome measure: A composite outcome of unsuccessful procedure or any of the following complications: intrauterine adhesions, infection, severe bleeding or damage to the genital tract.
Secondary clinical outcome measures: Rate of individual complications; rate of serious adverse events; need for additional surgical procedure(s) for miscarriage treatment; need for medical management of miscarriage.
NIHR HTA Funder Ref: PDF-2015-08-099
Sponsor Ref: RG_17-249
ISRCTN No.: 15586426
REC Ref: 19/WM/0021
IRAS No. : 253447
Sponsor: University of Birmingham
Chief Investigator: Dr Paul Smith
Coordinating Centre: Birmingham Clinical Trials Unit, University of Birmingham
This study is funded by the NIHR HTA.
The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.