SEE U v1.0
Research type
Research Study
Full title
Surgical Evacuation with intraopErative Ultrasound: a pilot trial to assess feasibility
IRAS ID
253447
Contact name
Paul Smith
Contact email
ISRCTN Number
ISRCTN15586426
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Miscarriage is the failure of pregnancy before 23 weeks, which is common in early pregnancy occurring in around one in five pregnancies. Miscarriage can have a negative effect on both the physical and mental health of the woman and her partner. Sometimes it is necessary for doctors to suggest surgical treatment. Unfortunately, this can be associated with various problems such as causing a hole in the womb, infection, scarring and bleeding.
I have recently completed work looking to improve hysteroscopy (a camera test which looks inside the womb) services. Through this work I have come into contact with women who have suffered from scarring inside the womb following surgical treatment of miscarriage. This can cause problems with periods and decrease the chances of getting pregnant in the future.
One of the ways I have tried to improve gynaecological services is by increasing the number of procedures performed under direct vision using hysteroscopy, with the aim of improving treatment success rates and reducing complications. Applying similar principles to surgical treatment of miscarriage, the main aim of this work is to assess whether viewing the inside of the womb, with an ultrasound scan, during the surgical removal of the pregnancy tissue can help with the success of the procedure. We are also looking to see if performing the procedure in this way can reduce complications such as infection, bleeding and scarring.
To answer this question a multi-centre randomised controlled study with an associated health economic evaluation is required. To ensure the feasibility of a large expensive trial it is essential to perform a pilot study. Performing a pilot study prior to the main study can avoid trials that will fail and increase the likelihood of success of the main study.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
19/WM/0021
Date of REC Opinion
24 Apr 2019
REC opinion
Further Information Favourable Opinion