About the SEE U trial

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.

 

Potential participants will be identified and approached by a member of the research team which will consist of doctors, research nurses and research midwives. All women undergoing a routine (low risk) surgical evacuation of products of conception will be considered for the trial. Their clinical notes will be screened in order to ascertain eligibility. Only a member of the patient’s existing clinical care team will have access to patient records in order to identify potential participants and check whether they meet the inclusion criteria or make the initial approach to patients.  It is expected that participants will mainly be identified in the early pregnancy units after ultrasound diagnosis of miscarriage and on the emergency gynaecology wards prior to surgical management of miscarriage.

The trial will be introduced through a comprehensive, evidence-based patient information sheet (PIS) that will be provided prior to the procedure.  Before deciding whether to enter the trial, the women will be given a chance to discuss the risks and benefits of surgical evacuation with or without intraoperative ultrasonography. Written consent will then be obtained prior to randomisation.

Once informed written consent is obtained, women will be randomised into the trial by a secure online randomisation system developed by the Birmingham Clinical Trials Unit (BCTU). Unique log-in usernames and passwords will be provided to those who are required to use the online system and/or who have been delegated the role of randomising participants into the study as detailed on the SEE U Trial Signature and Delegation Log. The online randomisation system will be available 24 hours a day, 7 days a week, apart from short periods of scheduled maintenance. A telephone toll-free randomisation service (0800 953 0274) is available Monday to Friday, 09:00 to 17:00 UK time, except for bank holidays and University of Birmingham closed days.

The study is designed to fit into the women’s usual care. In addition to usual care, those participating in study will receive a phone call from a member of the research team two weeks after the procedure to ask a few questions about their recovery. They will also be required to return to hospital four to eight weeks after the procedure for a follow-up hysteroscopy which will check that the surgical procedure has been successful.

Inclusion Criteria:

• Aged 16 years or over.
• Referred for surgical evacuation of products of conception.
• Willingness to be randomised between treatment modalities.
• Willingness to undergo office hysteroscopy 4-8 weeks following surgical management of miscarriage.
• Written informed consent obtained prior to surgical evacuation.

Exclusion Criteria:

• Incomplete or retained products of conception will be excluded from the trial as there are no widely used criteria for deciding which women should have surgical evacuation.
• Suspicion of malignant gestational disease.

Co-enrolment

Co-enrolment of participants into other trials will be permitted unless the trial is specifically looking into the surgical management of miscarriage.