Title: Surgical evacuation of miscarriage with and without intraoperative ultrasound: a programme of research
Funder: Department of Health and Social Care

Abstract: Background An estimated 140,000 women per year suffer from miscarriage costing the NHS over 350 million/year. It is thought that 15-20% of all pregnancies will end in miscarriage1 and this can have psychological and medical impacts on both women and their partners25. Surgical treatment of miscarriage was performed 61,912 times in in England between 2012 and 20136. Currently, the standard practice is to perform the procedure blindly. During a miscarriage the uterus is enlarged so it is more prone to trauma, which can result in bleeding and perforation. Some of the tissues of conception may be retained and infection can be introduced into the uterine cavity. Both trauma and infection are implicated in the formation of intrauterine adhesions (Asherman's syndrome), which are associated with pain, amenorrhoea, placental implantation problems and decreased fertility7.Intraoperative abdominal ultrasound allows the visualisation of instruments while they are in the uterine cavity and this has already been shown to reduce the incidence of uterine perforation in second trimester abortions8. Furthermore, intraoperative abdominal ultrasound may ensure more complete removal of products of conception with more gentle instrumentation and the smallest number of uterine cavity insertions. Thus, we hypothesise that simultaneous abdominal ultrasound during surgical evacuation of the uterus may increase complete removal of products of conception, decrease infection rates, reduce trauma, reduce bleeding and reduce the formation of the scar tissue in the uterine cavity.A high quality randomised controlled trial, with economic evaluation, is clearly needed to address these questions. However, before embarking on a large scale project, we aim to perform a feasibility study.Furthermore, we aim to develop core outcome measures for the surgical management of miscarriage. Core outcomes measures are an agreed, standardised set of outcomes based on what clinicians and service users (patients and carers) consider to be the important outcomes in the management of a condition9. These outcomes are disease specific and take into account both the potential benefits and harms of interventions. Aims 1 To perform a systematic review of the use of ultrasound during the surgical management of miscarriage and/or termination of pregnancy. 2 To develop core outcome measures for the surgical management of miscarriage. 3 To conduct a feasibility study to find out if an appropriately powered randomised controlled trial can realistically be undertaken.4 To use the results of the pilot study to design and apply for funding of a larger multicentre study. Plan of investigation and research questions Systematic review What is the evidence in the literature on the impact of intraoperative ultrasound on surgical management of miscarriage and/or termination of pregnancy? Randomised controlled feasibility study Are women willing to be randomised? What support is needed in units to ensure recruitment? Are outcome measurement tools and processes acceptable and adequate? What are the confidence intervals for outcomes, in particular intrauterine adhesions at 6 weeks follow-up? What are the follow-up and response rates to questionnaires? Potential benefits to NHS and patients Miscarriage can cause considerable psychological and physical stress. Complications can cause extra burden during an already delicate and distressing time. Optimisation of the surgical management for miscarriage has the potential to minimise this stress to women and their partners. Furthermore, improved patient care and reduced complications could reduce the number of bed days, increasing health service capacity and reducing costs.The development of an agreed, standardised set of outcomes for trials involving surgical management of miscarriage will help patients by ensuring that important outcomes with good measurement properties are incorporated and reported in all future studies in miscarriage. This will allow synthesis of results in meta-analysis and help preventing selective reporting.

Lay abstract: 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. The first stage of the project will be to look at all other work on the use of ultrasound scans during surgical management of miscarriage and termination of pregnancy. This will give me an opportunity to build on my skills in conducting a thorough review and report of existing research on a particular subject, which will be important for my future work. Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw conclusions when a group of studies is looked at as a whole. Increasingly, it is being realised that what is needed is an agreed standardised collection of outcomes a core outcomes set' for all trials in a specific area. I will review the literature for all the reported outcomes and ask patients and partners about outcomes important to them. Once I created a list of all the outcomes I will then survey clinicians, patients, partners, charities and support groups to identify the most important ones in miscarriage that can be used in all future research in the area.Most of my work will involve designing and running a study to see if performing a scan during the surgical procedure will help ensure complete removal of tissue and reduce the problems associated with surgical management of miscarriage. Women who have agreed to have surgical management of miscarriage will be approached and if they consent will be randomly allocated to treatment with or without a simultaneous scan of the womb. Data will be collected about the procedure and any subsequent visits to hospital related to the miscarriage. The women will also have a hysteroscopy (camera test of the womb) 6 weeks after the procedure to identify any scar tissue in the womb. To develop the research project I will be working closely with a team who are dedicated to running clinical trials. This will ensure that the project is conducted to the highest standards and provide me with the support to take on a leadership role within research.The hands on experience with this trial and other trials will be supported by formal teaching in how to conduct research trials and leadership. The final part of the work will involve analysing the results. The results from the study will be used to determine if a larger trial is needed and if any changes are needed in how the study was run. Depending on the results I will use some of the time to apply for funding for a bigger trial in more hospitals.

Research activity codes: 6.4 SURGERY
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH