Early Pregnancy Assessment Unit.docx



Canberra Hospital and Health ServicesClinical GuidelineEarly Pregnancy Assessment Unit (EPAU) Contents TOC \h \z \t "Heading 1,1,Heading 2,2" Contents PAGEREF _Toc503431070 \h 1Guideline Statement PAGEREF _Toc503431071 \h 2Scope PAGEREF _Toc503431072 \h 2Background PAGEREF _Toc503431073 \h 2Section 1 – EPAU Eligibility PAGEREF _Toc503431074 \h 2Section 2 – EPAU Referral Processes PAGEREF _Toc503431075 \h 3Section 2 – Methotrexate PAGEREF _Toc503431076 \h 4Section 3 – Misoprostol for the Medical Management of 1st Trimester Miscarriage PAGEREF _Toc503431077 \h 6Section 4 – Emotional Support PAGEREF _Toc503431078 \h 8Implementation PAGEREF _Toc503431079 \h 8Related Policies, Procedures, Guidelines and Legislation PAGEREF _Toc503431080 \h 8References PAGEREF _Toc503431081 \h 8Definition of Terms PAGEREF _Toc503431082 \h 9Search Terms PAGEREF _Toc503431083 \h 10Attachments PAGEREF _Toc503431084 \h 10Attachment 1 - EPAU Referral Process Flow Chart PAGEREF _Toc503431085 \h 11Attachment 2 – Early Pregnancy and Gynaecology Assessment PAGEREF _Toc503431086 \h 12Attachment 3 – Management of Methotrexate for Pregnancy Flow Chart PAGEREF _Toc503431087 \h 13Attachment 4 – Methotrexate in the treatment of ectopic pregnancy PAGEREF _Toc503431088 \h 14Attachment 5 - Diagnosing Viable Intrauterine Pregnancy PAGEREF _Toc503431089 \h 15Attachment 6 - Assessment of Pregnancy of Unknown Location (PUL) PAGEREF _Toc503431090 \h 16Attachment 7 - Misoprostol Management Pathway PAGEREF _Toc503431091 \h 17 Guideline StatementThis guideline describes the referral processes and the management of women requiring review in the Early Pregnancy Assessment Unit (EPAU).The EPAU is a referral service which operates by appointment only. Appointments are available 0900 to 1400 Monday to Friday (excluding public holidays) with Ultrasound appointments available between 0900 and 1030 only. ScopeThis document applies to the following staff working within their scope of practice:Medical OfficersMidwives and NursesStudent Midwives and Nurses under direct supervision.Back to Table of ContentsBackgroundThe EPAU is an appointment only outpatient service for women experiencing complications of pregnancy at < 20 weeks gestation.The EPAU is located in the Centenary Hospital for Women and Children (CHWC), Building 11, Level 2 of the Canberra Hospital campus. The EPAU is staffed Monday through Friday from 0800 to 1600 with appointments available between 0900 and 1400.Ultrasound appointments are available between 0900 and 1030 only. Back to Table of ContentsSection 1 – EPAU EligibilitySuitability criteria for referral to EPAU:Women with vaginal bleeding and/or mild abdominal pain with a positive βHCG and who are < 20 weeks gestationWomen with suspected Molar PregnancyWomen who have had an ultrasound (US) which confirms a miscarriage for discussion of management optionsWomen who have had an US which confirms retained products of conception with a recent pregnancy of < 20 weeks gestation who require further assessment and management.Women who are not eligible for EPAU assessment/management include:Women who are unwell and/or haemodynamically unstableWomen seeking a ‘routine’ US (e.g. dating, previous history of miscarriage, nuchal translucency etc.)Women seeking ‘routine’ early pregnancy or antenatal care Women with gynaecological indications (e.g. ovarian cysts, Poly Cystic Ovary Syndrome etc.)Women with non-pregnancy related conditions (e.g. back or musculoskeletal pain etc.)Women who are not pregnant Women whose pregnancy is > 20 weeks gestation.Women experiencing other problems in early pregnancy (vomiting, hyperemesis, back pain etc.) will be referred to the Emergency Department (ED) for assessment and management (+/- review in the ED by the On Call Gynaecology Registrar).Women whose pregnancy is ≥ 20 weeks will be referred to the Maternity Assessment Unit (MAU), Birth Suite, Foetal Medicine Unit (FMU) or ED as appropriate.Women who are seeking a ‘routine’ US, antenatal care or, women with a non-pregnancyrelated or gynaecological condition will be referred to their GP or other antenatalcare provider as appropriateBack to Table of ContentsSection 2 – EPAU Referral ProcessesRefer to attachment 1 for referral process flow chart.Who can refer to EPAU:MidwivesGeneral PractitionersEmergency Department Medical OfficersObstetrics and Gynaecology RegistrarsOther wards or units within the CHWC (internal referrals)Other local and interstate hospitals and health service providers (external referrals) Private Obstetricians and Gynaecologists.How to refer to EPAU:Referrals should be faxed to the EAPU on (02) 6244 3154.These will be triaged by the EPAU Midwife and the woman will be contacted within one business day when an appropriately scheduled appointment and plan of care will be discussed and arranged.Please note the EPAU is unable to provide a ‘walk in’ service and appointments are required. The EPAU is staffed Monday through Friday (excluding public holidays) from 0800 to 1600.Appointments are available between 0900 and 1400.As ultrasound appointments are available between 0900 and 1030 only women requiring an ultrasound will be asked to attend a morning appointment.Women may self-refer to the ED as necessary and once triaged should be assessed by an ED Clinician using the ‘Early Pregnancy and Gynaecology Assessment’ ED Referral Clinical Pathway, which can be found on the clinical forms register (see Attachment 2).Women who meet the criteria for this pathway may then be referred to the EPAU (by faxing a referral letter and all relevant documents).The woman may then be discharged from the ED with a discharge summary/letter. The EPAU Midwife will contact the woman within one business day to arrange an appropriately timed appointment.Back to Table of ContentsSection 2 – Methotrexate Methotrexate is used in certain circumstances for the medical management of ectopic pregnancy. Within the Canberra Hospital and Health Service Methotrexate is only to be administered in the Oncology Outpatient Department by staff assessed as competent in the administration of chemotherapy using cytotoxic precautions.Indications and Criteria for management with methotrexate:Ectopic Pregnancy (adnexal mass < 4cm)Serum βHCG ≤ 5,000iU/LPersistent Pregnancy of Unknown Location (PUL)Acquired Arterio Venous Malformation (AVM)Persistent βHCG following salpingotomyClinically and haemodynamically stable patientCompliant patient willing to attend for monitoringNo free fluid/no foetal heartbeat seen on transvaginal ultrasoundSurgery is contraindicatedNormal haematological, renal and hepatic function.Contraindications:PainHaemodynamic instabilityHaemoperitoneum.Alert:Women with conditions such as Gestational Trophoblastic Disease (GTD) or unusual ectopic gestations (such as cervical, cornual or caesarean scar implantation) must be managed by a Specialist Gynaecologist, Gynaecology Oncology Consultant or Medical Oncologist.Management: Refer to Attachment 4 – Methotrexate Management Flow Chart.Obtain confirmation from the patient that she is willing to comply with attending for regular serum βHCG monitoring following administration of methotrexate.The Medical Officer should discuss the case with the on call Gynaecology Consultant and Early Pregnancy Assessment Midwife and, determine whether methotrexate administration needs to occur on that same day.The Medical Officer is to obtain written consent from the woman for the administration of methotrexate. The Medical Officer will also prescribe an antiemetic and analgesia order pre-methotrexate pathology and provide pathology forms for day 4 and day 7 post methotrexate blood collection, discharge instructions and a medical certificate if required.The methotrexate dose is calculated on the woman’s Body Surface Area (BSA) (rounded to the nearest 5mg) and is to be ordered on both a Medication Chart and Medical Oncology Chemotherapy Sheet.This is then faxed to the Oncology Pharmacist who will dispense the methotrexate to the Oncology Outpatients Department. The woman then attends Oncology Outpatients which is located on level 4, Building 19; The Canberra Region Cancer Centre (CRCC) for the administration of the methotrexate (see Attachment 5 - Pharmacy guidelines on the use of Methotrexate in ectopic pregnancy).The EPAU Midwife will liaise with the CRCC and the woman in regard to the timing and review for the woman on day 4 and day 7 post administration of methotrexate.Day zero is the day of administrationPre-methotrexate pathology required – serum βHCG, LFT’s, FBC, UEC and Blood GroupDay 4 pathology – serum quantitative βHCG level onlyDay 7 pathology – serum βHCG level plus repeat LFT’s, FBC and EUC.Note: It is not unusual for the serum βHCG level to rise between day 0 and day 4. The comparison is made from the day 4 serum βHCG and the day 7 serum βHCG levels where it is expected a 15% reduction in the serum βHCG level should occur.If the serum βHCG level does not fall sufficiently at day 7 a second dose of methotrexate is usually recommended.βHCG levels are to be monitored weekly until negative (note a serum βHCG level of < 5 is considered negative) with additional treatment to be considered if the fall is less than 15% over any one week period.Back to Table of ContentsSection 3 – Misoprostol for the Medical Management of 1st Trimester MiscarriageMedical Management with Misoprostol for 1st trimester miscarriage may be offered when a diagnosis of complete or incomplete miscarriage has been established by demonstrating:evidence of miscarriage based on history, examination and serial serum βHCG levels (minimum of 2 x levels 48 hours apart demonstrating a fall of approximately 50%) and a formal ultrasound report confirming non-viable intrauterine pregnancy.Any management for miscarriage should not commence until the site and non-viability of the pregnancy has been confirmed and the following criteria have been met:Crown Rump Length (CRL) of > 7mm with absent foetal heart motion (FHM) on transvaginal ultrasoundMean Sac Diameter (MSD) of > 25mm with no embryo present (an embryonic or blighted ovum) on transvaginal ultrasoundAbsence of embryo with FHM > 2 weeks after a previous ultrasound which showed an Intra Uterine Gestational Sac (IUGS) without a Yolk Sac (YS)Absence of embryo with heartbeat > 11 days after a previous ultrasound which showed an IUGS with no YS> 70 days confirmed gestation and the MSD >18mm with no embryo or an embryo with CRL > 3mm with no heart activity.Refer to Attachments 5 and 6 for flow charts Diagnosing Viable Intrauterine Pregnancy and Assessment of Pregnancy of Unknown Location (PUL).Process for medical management (refer to Attachment 7): Document evidence of the woman’s Blood Group including Rhesus D statusDocument evidence that the woman has been counselled by a medical officer including: being given information and advice regarding the risks and benefits of medical management for miscarriage what to expect once misoprostol has been administered and thepotential side effects of misoprostol (short term pyrexia, nausea, diarrhoea, GIT upset etc.)The woman provides written and informed consent for medical management and administration of misoprostolThe woman is willing to comply with follow up recommendationsThe Medical Officer will prescribe misoprostol on an ACT Health (inpatient) Medication Chart which is scanned to the hospital dispensary for the woman to collect ‘to take at home’ (within 24 hours)Dose: 800 mcgRoute: bucally, sub-lingually or per vagina.The EPAU Midwife will follow up the woman by phone 2 business days post administration of misoprostolAppropriate clinical review to be arranged (+/- further investigations) as necessaryWoman may present to her nearest ED if necessary for urgent clinical review if she experiences any concerning symptoms or adverse effects (such as syncope, haemorrhage, excessive pain, allergic reaction etc.) The woman is to be given a pathology request form for a follow up serum βHCG level to be done one month post misoprostol.A patient ID label is to be placed in the EPAU patient tracking diary to ensure this is checked by the EPAU Midwife. The midwife will arrange appropriate follow up if this level is not negative The medical officer is also to provide the woman with an external prescription for anti-emetics and analgesia.If medical management is successful the woman follows up with her Referring Doctor and/or General Practitioner (GP) and the EPAU will send advice letter accordingly.If medical management is not successful the woman is to be reviewed and offered further management:Surgical Management (Dilatation and Suction Curettage) with post-operative follow up by Referring Doctor and/or GP ORA second dose of misoprostol – 600 mcg (with follow up as per initial dose of misoprostol). The women will also be provided with:EPAU contact detailsan external prescription for anti-emetics and analgesia (to be filled at a private pharmacy at the patient’s own expense).Back to Table of ContentsSection 4 – Emotional SupportEach women’s psychological response to an early pregnancy loss will vary considerably. Every woman undergoing a pregnancy loss will be offered follow up information by the EPAU midwife or attending doctor on support services available and will have appropriate referrals arranged as required.Back to Table of ContentsImplementation This Clinical Guideline will be accessible to all relevant stakeholders via the electronic policy/ guideline register on SharePoint. Education on the implementation of the guideline will be provided at appropriate multidisciplinary education sessions. Back to Table of ContentsRelated Policies, Procedures, Guidelines and LegislationPoliciesConsent and Treatment PolicyWork Health and Safety Management PolicyWork Health and Safety PolicyProceduresAnti-D Administration procedure Chemotherapy care of the adult patient Admissions from the Emergency Department to Ward Procedure LegislationWork Health and Safety Act 2011Human Rights Act 2004Health Records (Privacy and Access) Act 1997Back to Table of ContentsReferencesAl-Memar M, Kirk E, Bourne T. (2015) The role of ultrasonography in the diagnosis and management of early pregnancy complications. The Obstetrician and Gynaecologist; 17: 173-81. Australasian College for Emergency Medicine (2013). Guidelines on the implementation of the Australasian Triage scale in Emergency departments, Document No: G24, version 3, Nov 2013. Bourne T. A (2015). Missed opportunity for excellence: the NICE guideline on the diagnosis and initial management of ectopic pregnancy and miscarriage. Journal of Family Planning and Reproductive Health Care; 41: 13-19.Lipscomb, G.H. (2007). Medical Therapy for Ectopic Pregnancy. Semin Reprod Med; 25(2): 93-98National Institute for Health and Care Excellence (NICE) (2018). Ectopic pregnancy and miscarriage: Diagnosis and initial management in early pregnancy of ectopic pregnancy and miscarriage, NICE guidelines (CG154).National Institute for Health and Care Excellence (NICE) Pathways (2012): Management of ectopic pregnancy Health (2012) Maternity-Management of Early Pregnancy Complications. SG, Perkins A, Gibbons K et al. (2013) Can we use a lower intravaginal dose of misoprostol in the medical management of miscarriage? A randomised controlled study. The Australian and New Zealand Journal of Obstetrics and Gynaecology 53: 64–73Priest J et al (2015). Defining safe criteria to diagnose miscarriage: prospective observational multicentre study. British Medical Journal;351:h 4579 Royal College of Physicians of Ireland (2013). Criteria for non-viable pregnancy in the first Trimester: N Engl Med; 1443-1451.Royal College of Physicians of Ireland and Directorate of Quality and Clinical Care, Health Service Executive (2010). Ultrasound Diagnosis of early Pregnancy Miscarriage. Prince Alfred Hospital (RPA) (2011). Early Pregnancy Assessment Service. Methotrexate protocol for the Medical Management of Ectopic Pregnancy. Royal Women’s Hospital Victoria (undated). Health information Ectopic pregnancy: management. of Terms HCG: Human chorionic gonadotrophinEPAU: Early Pregnancy Assessment UnitUS: UltrasoundGP: General PractitionerBMI: Body Mass IndexLFT’s: Liver Function TestsFBC: Full blood CountUEC: Urea Electrolyte and CreatinineBack to Table of ContentsSearch Terms Maternity, Early pregnancy assessment unit, EPAU, Miscarriage, Emergency, Pregnancy, Mistoprostol, methotrexateBack to Table of ContentsAttachmentsAttachment 1 -EPAU Referral Process Flow ChartAttachment 2 -Early Pregnancy and Gynaecology AssessmentAttachment 3 -Management of Methotrexate for Ectopic Pregnancy Flow ChartAttachment 4 - Pharmacy Department Guidelines for the use of Methotrexate in the treatment of ectopic pregnancyAttachment 5 - Diagnosing Viable Intrauterine PregnancyAttachment 6 - Assessment of Pregnancy of Unknown Location (PUL)Attachment 7 - Misoprostol Management PathwayDisclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.Policy Team ONLY to complete the following:Date AmendedSection AmendedDivisional ApprovalFinal Approval 24 January 2018Complete ReviewWendy Alder, WY&CCHHS Policy CommitteeThis document supersedes the following: Document NumberDocument NameCHHS15/105Early Pregnancy Assessment Unit Referral ProcessCHHS13/547Maternity: Methotrexate for Ectopic PregnancyAttachment 1 - EPAU Referral Process Flow ChartAttachment 2 – Early Pregnancy and Gynaecology AssessmentThis form is used within the Emergency department as a referral pathway to EPAU, it can be found on the Clinical Records Forms Register on the ACT Health Intranet. Attachment 3 – Management of Methotrexate for Pregnancy Flow ChartAttachment 4 – Methotrexate in the treatment of ectopic pregnancyScope: CHHS pharmacy staff checking and preparing methotrexate for patients treated at CHHS and ordered by a doctor working for CHHS Dose: 50mg/m2 given by IM injection as a single dose. The body surface area (BSA) is calculated using BSA (m2) = √( [Height(cm) x Weight(kg) ]/ 3600 )? with the height in cm and the weight in kg. BSA is capped at 2m2The dose is rounded to the nearest 5mg. Rounding down is preferable to rounding up to limit any toxicities.Prescription requirements:Must be ordered on an approved CHHS chemotherapy inpatient form. All patient details and the dose should be very clearly written to avoid errors and delays in manufacturingThe height, weight and BSA must be clearly documented on the drug chart.Contact details or where the delivery is to be sent and when it is required should be clearly written on the order.Ordering Methotrexate from pharmacy:Oncology Pharmacy keep a stock of Methotrexate pre-filled syringes in the following strengths: 10mg, 25mg, 50mg and 80mg.A pharmacist will double check the calculations before the drug is supplied.All doses are to be rounded to the nearest 5mg.The drug chart must be faxed to the oncology pharmacy (bld 19, L3) during working hours Monday to Friday (9am to 4.30pm) – excluding public holidays. Fax: 6244 3516.Any requests for treatment at a weekend or public holiday must be scanned or faxed to the main pharmacy on Fax: 62444624 where the senior pharmacist on duty will assist with coordinating supply of the required dose.Any out of hour’s requests should be directed to the on-call pharmacist via the after-hours Clinical Nurse Consultant.During working hours oncology pharmacy will call an urgent courier to deliver the product to the nominated area. Outside these hours and on public holidays, collection from main pharmacy will be needed References:Eloson CJ, Salim R, Potdar N, Chetty M, Ross JA, Kirk EJ on behalf of the Royal College of Obstetricians and Gynaecologists (2016). Diagnosis and management of ectopic pregnancy. BJOG;123:e15-e55. New South Wales Health (2016). Methotrexate for ectopic pregnancy. Local Operating Procedure 5 - Diagnosing Viable Intrauterine Pregnancy(adapted from NICE guideline 2018)Attachment 6 - Assessment of Pregnancy of Unknown Location (PUL)(adapted from NICE guideline 2018 ) *ALERT: WOMEN WITH A PUL COULD HAVE AN ECTOPIC PREGNANCYAttachment 7 - Misoprostol Management Pathway ................
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