Type: DissertationSubject: HealthcarePages: 80 , Double Spacing (275 words/page)Academic level: MasterSources: 60Style: HarvardOrder Description to investigate the impact of a change in protocol for t

Title 

To investigate the impact of a change in protocol for the medical management of a first trimester miscarriage.  

Introduction  

In recent years there have been changes in the way that first trimester miscarriage is managed and treated (Nielson et al 2013). Miscarriage is when a pregnancy ends before the fetus would be considered able to survive outside the uterus (National Institute of Health and Care Excellence [NICE] 2017. In the UK,  this is considered to be before 24 weeks' gestation and is more common in the first trimester, the first twelve weeks of pregnancy (Schreiber, Crenin, Alto et al 2018).  It is thought to occur in one in four pregnancies so therefore represents a large number of appreciable morbidity in both primary and secondary care (Lusink, Wong, De Vries et al 2018). Initial presentation to medical services is often associated with lower abdominal pain in early pregnancy, with or without vaginal bleeding (Schreiber, Crenin, Alto et al 2018). Vaginal bleeding and or abdominal pain in early pregnancy is the most common reason for women to attend emergency gynaecology departments and accounts for 50,000 inpatient episodes in the UK annually (Bourne 2015). It must be noted that not all patients that present with pain and or bleeding in early pregnancy experience a miscarriage. However, numbers quoted in most literature quote 25%, this is an average as miscarriage becomes increasingly more common with maternal age (Maconochie et al 2007, Nybo et al 2000).  Miscarriage is diagnosed by Ultrasound imaging and can described as either; threatened miscarriage, anembryonic pregnancy, inevitable, early fetal demise and incomplete miscarriage. Increased access to ultrasonography has likely improved diagnosis of miscarriage rather than increasing incidence of miscarriage (NICE 2017).

(see table 1)

It is argued that most miscarriages are likely to be due to chromosomal abnormalities, however, the cause of most miscarriages is unknown despite considerable research into fertility treatments and recurrent miscarriage (Schreiber, Crenin, Alto et al 2018).

Table 1 Types of Miscarriage

 (Jurvovic, Overton,Bender-Atik 2013)

Prior to the introduction of antiprogestogens and prostaglandins (Mifepristone and Misoprostol) for management of an incomplete miscarriage, the gold standard treatment was surgical suction evacuation under general anaesthetic (El Refaey H , Hinshaw, Henshaw 1992). Following the publication of the NICE guidance in 2012 this was changed to prostaglandin only treatment. This was subsequently followed up in a NICE routine surveillance paper in 2017; advice for further studies was noted. Options for treatment are currently either conservative management and await events, medical management with misoprostol only, moving away from surgical interventions and Mifepristone. NICE (2012) suggest that in 90% of women the use of prostaglandin only will be an effective treatment to complete miscarriage. The change in the treatment protocol is outlined in table 2.

Conservative management as described by NICE (2012) is to await events with open access to an appropriate emergency gynaecology unit or early pregnancy assessment unit (EPAU) should support be required. Miscarriage can take several days or sometimes weeks, especially if those patients that have remained symptomless (Lusink et al 2018). This is often not acceptable to women that want to have closure and carry on with normal activities (Furlund 2017).  The uncertainty of how long it will take to pass fetal tissue, and miscarriage event to be concluded, is often a reason for women to decide on intervention with medical or surgical managed miscarriage (Furnlund et al 2017).   

Surgical management of miscarriage, under general or local anaesthetic with electrical or manual vacuum suction minimises time for miscarriage to be completed but carries a small risk,1 in 1000, of complications (Royal College of Obstetricians and Gynaecologists 2019) These include perforation, cervical tear, intra-abdominal trauma, haemorrhage, infection, Ashermanns syndrome and risks associated with preterm birth (Lemmers et al 2016)

Medical management, under investigation in this paper, can be also take a number of days or weeks to conclude. This can also be unacceptable to some women (Lusink et al 2018). Medication prescribed for management of miscarriage was a combination of two drugs mifepristone and misoprostol (see table 2 ). Currently misoprostol only is prescribed for treatment of incomplete miscarriage. Prior the NICE Guideline published in 2012 a two-step approach to medical management was common practice. This was administering two drugs mifepristone and misoprostol 24-48 hours apart as remains current practice for termination of unintended pregnancy (Saraswat, Ashok and Matter 2014).

Table 2 Medical Management of Miscarriage Treatment Protocols

Rational for study

The interest for this study relates to changes in the clinical practice protocol for management of miscarriage in 2013 following publication of the new NICE guidance in September 2012 which superseded the Royal College of Obstetricians and Gynaecologists green top guideline (2006).  In the unit where the study will occur both mifepristone and misoprostol were prescribed for incomplete miscarriage management.  Since this change in practice, anecdotal evidence suggests that locally, senior clinicians’ perceive there to be a noticeable increase in readmission of patients and numbers of patients requiring further medical or surgical treatment to complete a miscarriage.    

Aim of Study

To investigate the impact of a change in protocol for the medical management of a first trimester miscarriage.  

 Primary Objectives 

• To identify whether a change in protocol has increased the number of readmissions since implementation of the NICE guideline (2012).

Secondary Objectives

• To investigate if vaginal bleeding pretreatment is linked to treatment outcomes. 

• To explore numbers of patients requiring further medical or surgical treatment to complete the miscarriage

• To compare the two treatment protocols outlined in table 2 in terms of outcomes

Inclusion Criteria: 

• Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 15+6 weeks of pregnancy (this is the gestational age used as a cut off point in EPAU for obstetric care) that choose to have medical management of miscarriage; in two separate comparison years.

 Exclusion Criteria: 

• Women whom opted for alternative methods of miscarriage management initially (expectant or surgical) 

• Women experiencing retained products of conception following termination of ongoing unintended pregnancy. 

Research Method 

To investigate the impact of change in protocol for the medical management of a first trimester miscarriage, a retrospective clinical notes audit comparing two separate years of data will be carried out. . Clinical audit is a part of the continuous quality improvement process (Hexter 2013). It consists of measuring a clinical outcome or a process against well-defined standards, in this case an established body of evidence that validates the guidance from NICE in 2012.

It is intended to compare two separate years of data to compare outcomes of protocol A (prior to protocol change in 2013 ) and protocol B, current practice post protocol change (see table 2 )  

This study will employ a quantitative method to measure the numbers of patients requiring re admission and additional treatment following an incomplete miscarriage and any correlation in symptoms prior to diagnosis. In this study the comparison between clinical practice and the standard may lead to the formulation of a strategy, in order to improve care quality (Henkel and Shaw 2018).

Only information about miscarriage attendance will be accessed as part of the study and no other information will be identified including subsequent attendances.

Audit permission will be sought from the Trust Clinical Management Group (CMG) audit lead as part of organizational permissions; followed by hospital ethics approval and IRAS.

Data Collection

Anonymised data sets will be analysed for numbers of patients requiring re treatment to test the hypothesis.. Access to patient notes will be required which will be requested via the hospital’s internal electronic management system.  These clinical notes will be identified by the trust code for medical management of miscarriage and system numbers noted to enable them to be requested. This will identify women that have had a medically managed miscarriage during that year. The data analyst in the local trust will be contacted to ensure accurate selection of patients for the study as stated on the inclusion criteria, to safeguard only retrieving the required case notes. Case notes will be kept in a locked filing cabinet on the unit that the patient will have attended and returned to file as soon as the required information has been documented on a spreadsheet, which will be kept on a hospital password protected computer drive.

 A spreadsheet designed to answer the proposed question will document and record: 

• Expected gestational age at first attendance  

• Vaginal bleeding present at first attendance

• Retained products of conception, diagnosed via ultrasound report

• Gestational sac intact or not seen on ultrasound report

• Number of readmissions

• Required for re-treatment, medical or surgical

Patient information will be completely anonymised and non-identifiable in a spreadsheet following the extraction of the required information from the case notes. 

It must be noted that only information related to the study will be accessed.

Analysis

It is intended to analyse the data in numbers of patients needing further treatment and whether they had symptoms, with comparison of numbers of patients having mifepristone, and analysing the data sets form each cohort. 

Data sets will be tested using chi square. It may be that rather than correlational, causal -comparative methods as the study is post event.

Dissemination of Findings

The audit data analysis will be disseminated for educational and learning purposes. Results will also be shared as part of the organisation’s audit group as required by hospital polic. In the event of key findings being of interest it could inform further research and the possibility of care improvement for patients moving forward. Effects of the change in treatment protocol may have differing variables that may require further studies.

References

BOURNE T (2015) A missed opportunity for Excellence: the NICE guideline on the diagnosis and initial management of ectopic pregnancy and miscarriage, Journal of Family Planning Reproductive Health Care, 41:13-19

BRADLEY E, HAMILTON-FAIRLY D (1998) Managing miscarriage in Early pregnancy assessment Units. Hospital Medicine (59) pp 451-456.

EL REFAEY H , HINSHAW K , HENSHAW R, SMITH R. TEMPLETON A (1992)

Medical management of missed abortion and anembryonic pregnancy. British Journal Medicine, 305:1399

FURNLAND A, JOKUBKIENNE L, SLADKEVICIUS P , VALENTINE L. (2017) Misoprostol vs expectant Management in women with early non-viable pregnancy and vaginal bleeding :a pragmatic randomised controlled trial . Ultrasound Obstetrics and gynaecology (51) pp24-32

HENKEL A, SHAW K. (2018) Advances in the Management of Early Pregnancy Loss. Current opinion Obstetrics and Gynaecology 30:419-424

HEXTER AT (2013) How to conduct a clinical audit : a guide for medical students. Manchester Royal Infirmary. National AMR

JURVOVIC D, OVERTON C, BENDER-ATIK R (2013) Diagnosis and Management of First Trimester Miscarriage. British Medical Journal 346:3676

LEMMERS M, VERSCHOOR MA, HOOKER AB , OPMEER BC, LIMPINS J, HUIRNE JA et al (2016) Dilation and curetage increases the risk of subsequent preterm Birth : a systematic review and meta-analysis. Human Reproductive Medicine. 31(1)

LUSINK V, WONG, DE VRIES B , LUDLOW J (2018) Medical management of miscarriage : Predictive factors of success . Australian and New Zealand Journal of obstetrics and gynaecology. (58) pp 590-593

MACONOCHIE N,DOYLE P, PRIOR S, SIMMONS R .(2007) Risk factors for first trimester miscarriage-results from a UK -population based case-control study. British Journal of obstetrics and Gynaecology 114:170-86

NEILSON J, HICKEY M, VAZQUEZ J (2006). "Medical treatment for early fetal death (less than 24 weeks)". Cochrane Database, Database of Systematic Reviews (3) [online] CD002253.

NICE (2012) Ectopic pregnancy and miscarriage: diagnosis and initial management

Clinical guideline [CG154] Published date: December 2012

NICE (2017) Ectopic pregnancy and miscarriage: diagnosis and initial management

Clinical guideline [CG154] 4 year Surveillance

NYBO ANDERSEN, A M et al. (2000) Maternal age and fetal loss: population based register linkage study, British Medical Journal, (Clinical research ed.) 320(7251) pp 1708-12.

ROYAL COLLEGE OF OBSTETRICIANS AND GYNAECOLOGISTS [ Online] Available at https://www.rcog.org.uk/globalassets/documents/patients/patient-information-leaflets/pregnancy/pi-early-miscarriage.pdf [accessed on 4/4/19]

SARASWAT L, ASHOK PW, MATHUR M (2014) Medical Management of Miscarriage. The Obstetrician and Gynaecologist. 16:79-85

SCHREIBER C, CREININ M, ATRIO J , SONALKAR S, RATCLIFFE J, BARNHART K (2018) Mifepristone Pre-treatment for the Medical Management of Early Pregnancy Loss. The New England Journal of Medicine, 378 (23)

SHIERS C.(2003) Abnormalities of early pregnancy. Myles' Textbook for Midwives. 14th Edition. Churchill Livingstone

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