Surgical evacuation with intraoperative ultrasound (SEE U): A randomised controlled trial

Paul P Smith; Versha Cheed; Lee Middleton; Adam J Devall; Feras Izzat; T Justin Clark

doi:10.1016/j.ejogrb.2024.04.004

Surgical evacuation with intraoperative ultrasound (SEE U): A randomised controlled trial

Eur J Obstet Gynecol Reprod Biol. 2024 Apr 8:298:6-11. doi: 10.1016/j.ejogrb.2024.04.004. Online ahead of print.

Authors

Paul P Smith¹, Versha Cheed², Lee Middleton², Adam J Devall³, Feras Izzat⁴, T Justin Clark⁵

Affiliations

¹ Birmingham Women's & Children's Hospital and University of Birmingham, Birmingham, UK. Electronic address: paul.smith@doctors.net.uk.
² Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
³ Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁴ University Hospitals Coventry and Warwickshire, Coventry, UK.
⁵ Birmingham Women's & Children's Hospital and University of Birmingham, Birmingham, UK.

PMID: 38705012
DOI: 10.1016/j.ejogrb.2024.04.004

Abstract

Objectives: To test whether intraoperative ultrasound can reduce the incidence of early and late complications following surgical removal of products of conception.

Design: This was a prospective, multicentre, randomised, open clinical trial to assess feasibility. It was performed in two University Teaching hospitals in the West Midlands, England. The population consisted of women aged 16 years or over who were referred for surgical management of miscarriage. Patients were randomised to surgical management of miscarriage with either continuous intraoperative ultrasound or without intraoperative ultrasound. Process outcomes included the proportion of eligible women screened and proportion of eligible women randomised, attrition rates, evaluation of outcome measurement tools and acceptability. The primary clinical outcome was a composite outcome of unsuccessful procedure or a complication.

Results: Fifty-nine women requiring surgical management of miscarriage were randomised. The conversion rate for entry into the trial was 59/79(75 %; 95 %CI = 64-84 %). The composite clinical outcome was attained in 5/27(19 %) patients who had surgery without ultrasound and 7/28(25 %) patients who had surgery with ultrasound (RR = 0.74;95 %CI = 0.26, 2.10). When we excluded the patients that could not attend their hysteroscopy appointment, due to COVID-19 pandemic, 5/27(19 %) of patients who had surgery without ultrasound and 5/25(20 %) of patients who had surgery with ultrasound attained the composite clinical outcome (RR = 0.93;95 %CI = 0.30, 2.90).

Conclusions: This multicentre pilot study showed that a large RCT comparing surgical management of miscarriage with and without intraoperative ultrasound is feasible.

Keywords: Evacuation of retained products of conception; Miscarriage; Surgical management of miscarriage; Ultrasound.