Compliance with a guideline on outpatient medical management of miscarriage in a gynaecology ED

Over the course of the past 12 months, spurred on by the COVID-19 pandemic, the Gynaecology Emergency Department (GED) at Liverpool Women's NHS Foundation Trust made some adaptations to the care provided to pregnant women, in line with guidance from the Royal College of Obstetricians and Gynaecologists (RCOG) (2020). One of the adaptations made was to offer women who have had a missed miscarriage the option of having medical management as an outpatient. The Miscarriage Association (2022) defines a missed miscarriage as one where the fetus has not developed or has died, often with the woman displaying no signs or symptoms.

Guideline 2 on the management of miscarriage at Liverpool Women's NHS Foundation Trust was recently updated following new evidence from the MifeMiso trial by Chu et al (2020a). Previously, the Trust's Guideline 1 was implemented in 2018 to reflect the National Institute for Health and Care Excellence (NICE) (2021) guideline on the diagnosis and initial management of ectopic pregnancy and miscarriage. Prior to offering outpatient management, all women were admitted as an inpatient to the Gynaecology Unit. Not only was the updated guideline in line with current evidence, it offered women and their families greater autonomy and involvement in decision-making in their care, which is advocated by the RCOG (2016). As a result, it also avoided unnecessary hospital admissions and reduced footfall throughout the Trust; this was particularly important at a time when we were trying to reduce transmission of COVID-19. Due to changes in practice, it was therefore vital to ensure that standards of practice we being adhered to in order to provide safe and effective treatment to patients. The audit looked at the outcomes of this treatment and its potential cost-effectiveness in relation to avoiding hospital admissions.

Background

An early miscarriage is the loss of a pregnancy ≤13 weeks' gestation (NICE, 2021). This is usually diagnosed by a transvaginal/transabdominal pelvic ultrasound, often after a woman has experienced symptoms of abdominal pain and/or vaginal bleeding (Chu et al, 2020b). As per the NICE guideline (2021), a miscarriage is diagnosed when:

• The crown-rump length (CRL) is less than 7 mm without a fetal heartbeat
• The mean gestational sac diameter (MGSD) is less than 25 mm with no fetal pole
• There has been a lack of progression of growth on ultrasound over 10–14 days or there has been regression, for example, a previously seen fetal pole no longer present on repeat ultrasound.

According to Tommy's Charity (2023), an estimated 1 in 5 pregnancies ends in miscarriage, with the majority occuring in the first 12 weeks. In 2017, this equated to approximately 125 000 early miscarriages annually in the UK, accounting for around 50 000 hospital admissions (Chu et al, 2020b). There are three main ways in which a miscarriage can be treated/managed: expectantly (allowing the pregnancy to pass naturally without any treatment), medically (with misoprostol, or mifepristone combined with misoprostol), and surgically (NICE, 2021). Where not contraindicated, the patient should be given appropriate counselling on each management option, detailing the risks, benefits and the success rates. The woman should also be given adequate time to make her decision regarding her treatment (Chu et al, 2020b). The management of miscarriage should be a joint, informed decision between the patient and health professional, and individualised for the patient (Jurkovic et al, 2013).

Many factors influence a patient's choice of treatment, and often women want to initiate treatment as promptly as possible (Evans et al, 2002). This may mean that they choose to have outpatient medical management because this can be started on the day of diagnosis, meaning the patient does not have to wait for an admission date for surgery or to have inpatient medical management.

In 2020, the Trust updated its guidance, Guideline 2, on the medical management of miscarriage following the publication of the results of the MifeMiso Trial (Chu et al, 2020a). This was a large randomised, placebo-controlled, double-blind clinical trial of 711 women across 28 UK hospitals. It found that medical management of missed miscarriage is more effective when given over two stages. The first stage involved the administration of oral mifepristone 200 mg (progesterone receptor antagonist) and the second misoprostol (a synthetic prostaglandin analogue) 2 days later. The MifeMiso trial (Chu et al, 2020a) showed a significant reduction in the number of women who failed to pass the gestational sac in 7 days with mifepristone compared with the use of misoprostol alone: only 17% of the randomly assigned women who had both stages of treatment did not pass the gestation sac. A previous study by Schreiber et al (2018) based in the USA yielded similar results, proving the efficacy of pre-treatment with mifepristone. Both studies demonstrated that this treatment was safe, with each showing low rates of serious adverse events.

The use of the two-stage approach has also been shown to be cost-effective in studies by Nagendra et al (2020) and Okeke Ogwulu et al (2021). Providing a treatment to women who have miscarried that is both safe and cost-effective is paramount (Barnhart, 2020). The Trust's Guideline 1 had stated that patients would have mifepristone orally in the department then they were allowed to go home, and self-administer the misoprostol 2 days later either vaginally, orally or sublingually. The vaginal route was encouraged, however the choice was down to the patient's preference.

It is not uncommon for a clinician or NHS trust to move away from a NICE guideline because it is simply a guideline that can inform clinical practice and aid the clinician in decision-making – guidelines do not dictate a course of action. The NICE (2021) guideline on the management of miscarriage states, as do all its published guidelines, that health professionals must take the recommendations into account when exercising their judgement, alongside the individual needs and preferences of a patient. It is not mandatory to apply the guidelines and they do not override the clinician's responsibility to make decisions that are appropriate to the individual. Local adaptation of existing guidelines should only ever be changed if the supporting evidence has changed since the release of a guideline (Graham and Harrison, 2005). In this instance, the MifeMiso Trial (Chu et al, 2020a) supersedes the NICE guideline and the Trust, therefore, adapted its local guideline to follow the latest evidence.

Medical management

Advantages

• Avoidance of general anaesthetic and risks associated with surgery
• Faster completion compared to expectant management (Lusink et al, 2018)
• Medical management is known to be a cheaper option than surgical, with both having similar rates of infection (Petrou et al, 2006).

Disadvantages

• Pain and increased need for analgesia
• Trauma of passing pregnancy at home
• Increased duration of bleeding surgical management may still be required (Sur et al, 2009).

As described above, medical management of miscarriage is carried out in two stages, as per the Trust's local guideline. The two drugs given are mifepristone (a progesterone receptor antagonist) and misoprostol (a synthetic prostaglandin analogue). Misoprostol induces contractions in the myometrium (uterine contractions) to aid the expulsion of the pregnancy. Mifepristone is given prior to prime the myometrium prior to prostaglandin exposure (World Health Organization, 2018). Women often describe experiencing cramping-type pain, similar to that of strong period pain and sometimes as severe as labour pains, requiring strong analgesics, such as codeine phosphate.

Clinical audit aims and objections

The clinical audit had two main aims. The first aim was to analyse whether the care of patients receiving outpatient medical management of miscarriage followed the Trust's local clinical guideline on this.

The second was to determine the effectiveness of this method of treating a missed miscarriage by looking at the outcomes, for example, whether women went on to require further treatment or hospital admission. This enables us to determine whether it has been cost effective for the Trust.

The audit looked at all patients who had undergone outpatient medical management of miscarriage within the GED in the 3-month period between 1 November 2020 and 31 January 2021 to determine whether the standards had been met in each case.

Method

Approval for the audit was gained from the clinical audit and effectiveness department within the Trust. Request for permission to gain access to electronic patient notes was then sought from the Trust's information team and the two main IT systems in the Trust. These are Meditech and PENS, which are used to enter the casenotes of all patients who come through the GED, and the medications they are prescribed. The audit looked at the notes for patients who had been diagnosed with having a miscarriage between 1 November 2020 and 31 January 2021, who were eligible and had chosen to have outpatient medical management of miscarriage. This yielded 100 patients. The author (KM) then examined whether the standards within the guideline had been followed. The information was entered into an Microsoft Excel spreadsheet and the results collated. The data were anonymised for use within the data collection tool. General Data Protection Regulations (GDPR) under Data Protection Act 2018 were followed at all times.

Eligibility criteria for having an outpatient medical management of miscarriage included:

• Singleton pregnancy less than 9 weeks'+6 days' gestation by CRL and less that 13 weeks' gestation by dates. These dates were chosen at the Trust because it was considered prudent to admit anyone above this time span to hospital for monitoring in case of heavy vaginal bleeding
• Haemoglobin level of 90 g/L
• No contraindications for misoprostol
• If any ongoing medical problems or clotting disorders, must be discussed with ST3+ level doctor.

The audit standards measured are presented in Table 1.

Follow-up information

The miscarriage was considered as being complete if a patient had a negative urine pregnancy test, which she was asked to take at home 3 weeks following commencement of treatment as recommended by NICE guidelines (2021). A negative pregnancy test at 3 weeks would suggest all the pregnancy tissue has passed and the miscarriage is complete. Patients were advised to attend or contact the GED if they have a positive pregnancy test at 3 weeks and a pelvic ultrasound was arranged.

Additionally, although not a standard on the guidelines, the author examined whether the patient required any other treatment such as admission to hospital for observation (due to complications, pain or heavy bleeding) or if they required surgery to complete the miscarriage.

Ethical considerations

This study did not require ethical committee review because it was solely concerned with determining compliance with the published Trust clinical guideline.

Results

The aim of the audit was to determine whether local clinical guidelines (Table 2) were followed. The total number of patients identified as having outpatient medical management of miscarriage between the dates specified was 100.

There were high levels of compliance with standard 3 and standard 4 of Guideline 2, which in both cases was 100%. These standards relate to the prescribing and administration of mifepristone, and advising the patient on how and when to administer the misoprostol. As the mifepristone is a controlled drug within the Trust, and it is a key step in the process, it was unlikely that this would be missed. These were the only two standards that yielded 100% compliance rates.

Standard 2 had mixed levels of compliance because it comprises 3 parts. Of the 100 women, 98 were prescribed codeine phosphate, and the other 2 had allergies; all patients were prescribed misoprostol. However, in the case of only 1 of the 100 patients was it documented in the casenotes that paracetamol had been advised. One reason for this may be that the clinician assumed that the patient would know to take paracetamol since it is a readily available and commonly used analgesic and therefore did not consider that this needed to be advised and, because the clinician did not prescribe paracetamol, there was no need to document this. There is no evidence to suggest that paracetamol was advised and not documented, therefore, it is to be assumed that it was not advised. The fact that it was not documented by the doctor or nurse could be negated by the leaflet given to patients on outpatient medical management of miscarriage, which details what to expect during and following medical management of miscarriage at home. It explains what level of pain/bleeding is expected and when to contact/attend the GED. It recommends what analgesia to take and when to take the 3-week urine pregnancy test at home. The clinician may not have documented that they recommended paracetamol because they may have given the patient a leaflet, however this if often not documented and it is not known if the patient read this information. This leaflet is currently available in English only.

Standard 1 showed that 92 patients had a point of care haemoglobin test, with 15 requiring a full blood count; however, only 7 of the 15 had this done. A full blood count is required if haemoglobin levels are less than 100 g/L. As the treatment of mifepristone and misoprostol is to induce bleeding, it is therefore vital to ensure that there is a baseline haemoglobin test result and to detect any possible anaemia prior to starting treatment.

Against standard 6, it can be seen that 8 of the 100 patients had to receive a second dose of misoprostol because they did not experience any bleeding 24 hours after the first dose. The second dose was successful in obtaining a complete miscarriage. Lower levels of compliance were also found in the follow-up telephone call to check the wellbeing of the patient and to assess whether the treatment has been effective. During this phone call the clinician asks the patient if she has had any bleeding after the treatment and if she has not feel there was sufficient bleeding or there was no bleeding, they will be invited in for a repeat dose of misoprostol. The audit found that 13 of the 100 patients had not received a phone call 48 hours after the second part of the treatment. Of these 13, it was considered that 7 did not require a follow-up call. On further investigation, it was found that they did not need one for reasons such as the patient had phoned the GED prior to the call for advice or the patient had attended the GED prior to the call for reasons such as pain or bleeding. However, 8 of the 100 patients did require a further dose of misoprostol to induce adequate bleeding to complete the miscarriage.

Another aim of this audit was to show the outcomes of the outpatient medical management of miscarriage treatment. Out of the 100 patients included in the audit, 15 required further intervention such as surgery or admission to hospital for observation. Six of the 15 patients required surgical intervention for an incomplete miscarriage. The other 9 women were admitted for observation due to heavy vaginal bleeding and, when an ultrasound was performed, they had had a complete miscarriage and were discharged home the following day.

These patients were all admitted overnight when there is usually a very junior doctor on duty in the GED, and often little to no scanning facility. Had these patients presented during the day, they would most likely have been scanned in the GED and a complete miscarriage would have been diagnosed, which may have prevented the need for admission. In the MifeMiso Trial (Chu et al, 2020a), 17% of women who had a combination of mifepristone and misoprostol required surgical intervention to complete the miscarriage, so the Trust had expected to have some patients who would require further intervention such as surgery. This information is provided to patients on the consent form they sign prior to starting treatment.

There were no adverse events documented in the patient casenotes regarding the treatment and none of the patients required a blood transfusion.

Conclusion

This audit set out to assess compliance with the newly implemented local Trust guideline on the outpatient management of miscarriage. The guideline had been updated in line with current research carried out by Chu et al (2020a), which found that the two-stage approach for medical management of miscarriage, ie administering mifepristone and misoprostol, was more effective than the use of misoprostol alone.

There is an expectation that each of the standards in the guideline will have a compliance rate of 100%. As mentioned in the results, the audit yielded mixed levels of compliance. Areas such as the prescribing and administering medication had the highest compliance levels. However, there were much lower levels of compliance in relation to carrying out the haemoglobin test and the follow-up telephone call. Possible reasons for low compliance levels could be the use of multiple systems to document treatments, assessments etc, report scans and prescribe. Going forward, the Trust is moving to a single system that would provide access to patient scan results, blood tests results, medication prescribing and patient record keeping, which should bring improvements.

The patients in this audit were all seen within a busy emergency department, alongside other follow-up clinic patients and emergency presentations who had either self-presented or been brought in by ambulance. Patients who have been diagnosed with having a missed miscarriage are referred to the GED from several areas including the imaging department, where they would have been sent for a routine ultrasound. However, most of these patients are referred from the Early Pregnancy Assessment Unit (EPAU) based within the GED. A study by Wendt et al (2014) found that having specifically allocated/dedicated staff to look after women in the ED who had suffered a miscarriage resulted in better patient/clinical outcomes. Other pressures in the department and human factors, such as such as poor communication between staff, heavy workloads, staffing deficits, and miscarriage patients being treated alongside emergency attendants with no dedicated staff for pregnancy loss patients, will play a large role in the lower compliance levels.

All patients who fitted the eligibility criteria for outpatient medical management of miscarriage were offered this option. To make a better assessment and clinical judgement on the clinical impact of the NICE guidelines, all diagnosed miscarriages under 13 weeks would need to be included.

Prior to offering outpatient medical management of miscarriage all patients would have been admitted to hospital to have inpatient management. As a result of offering outpatient management over the 3-month period covered by the audit has examined, the Trust has saved about £61 484. The costs include the 15 patients who required admission and 9 of those who required surgical intervention.

However, it is important to acknowledge the patient's experiences of having their treatment at home. During the follow-up phone call some patients reported that they found the experience distressing and, in hindsight, they would probably have preferred to have been admitted to hospital.

Recommendations for practice

The processes within the GED have been shown to be robust, with compliance levels at a reasonably high level with the guideline standards that were audited.

The results of this audit will be presented to nursing and medical staff of the GED to improve standards compliance. This will be added to the governance board in the GED and discussed in the weekly safety huddles. It will also be added to the GED updates on Microsoft Teams. A post-education audit would need to be carried out to measure any improvement.

Following the audit, the author has devised a checklist to ensure that all the standards within the guideline are being followed. This is to provide the clinician a prompt to carry out each of the standards correctly. The checklist will be in paper form and will kept in the patient's temporary paper records until completion of treatment, when it will be scanned into the electronic casenotes.

Although it is important to ensure that clinical standards are being followed and that they are effective, what this audit has not done is to consider the patients' experiences. It would therefore be beneficial to carry out further research, for example using focus groups, to identify common themes running through patients; experiences. The author would also recommend in-depth training on communication around the discussions that clinicians have with patients and their families about pregnancy loss and the management options available.

Because many miscarriages are diagnosed in the Early Pregnancy and Gynaecology Unit (EPAU), women would ideally not be referred to the GED for management. Going forward, the EPAU team plans to develop and introduce a dedicated team to counsel and provide treatment for a miscarriage. This should provide a better experience for the patient as they will no longer have to be seen alongside emergency attendances.

The outpatient medical management of miscarriage leaflet that is given to patients should also be made available in other languages.

A final recommendation would be to expand the gestation for outpatient medical management of miscarriage to 13 weeks' gestation in line with the findings of the MifeMiso Trial (Chu et al, 2020a).

KEY POINTS

• The results of this audit are on the whole positive and show that the Gynaecology Emergency Department has a robust process in place
• Miscarriage effects approximately 1 in 5 pregnancies
• Medical management of miscarriage is considered to be a safe and effective treatment option
• Most women will go on to have a healthy pregnancy following a miscarriage
• The administration of mifepristone prior to misoprostol is optimal for treating a missed miscarriage medically

CPD reflective questions

• How would you discuss outpatient medical management of miscarriage with your patients?
• What does your Trust offer in terms of treatment to women who have miscarried?
• Does your Trust follow the National Institute for Health and Care Excellence (2021) guidance, or does it reflect the results of the MifeMiso Trial (2020a)?