PREGNANCY OF UNKNOWN LOCATION (PUL) - CLINICAL GUIDELINE 1. Aim/Purpose of this Guideline

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1 PREGNANCY OF UNKNOWN LOCATION (PUL) - CLINICAL GUIDELINE 1. Aim/Purpose of this Guideline All clinical staff working in the Division of women, children & sexual health to provide evidence based guidance in the management of pregnancy of unknown location (PUL) 2. The Guidance Pregnancy of Unknown Location (PUL) The term pregnancy of unknown location is used whenever there is a positive pregnancy test and no ultrasonic evidence (on transvaginal scan) of an intra or extra uterine pregnancy. This occurs in up to 30% of early pregnancy scans (1) Prior to the scan a full history is taken and interpretation of the history and scan findings leads to the sonographer choosing one of the following diagnoses (on the viewpoint menu): PUL likely miscarriage (if a good history of heavy bleeding with clots and crampy pains) PUL possible early intrauterine pregnancy (if uncertain dates, minimal bleeding and homogenous echogenic thickening of endometrium) PUL possible ectopic (minimal bleeding, unilateral pain, thin endometrium with trilaminar appearance or some free fluid) Assessment Clinical assessment Serum βhcg FBC & Group and antibodies (if suspect ectopic) Management Expectant management of PUL has shown to be safe and reduces the need for unnecessary surgical intervention and is not associated with serious adverse outcome. However, multiple visits to the early pregnancy unit are often necessary before a diagnosis is made (2) If the woman is asymptomatic with a PUL and there is no ultrasound evidence of an ectopic pregnancy, she can be managed conservatively as an outpatient. She should be given the RCHT patient information leaflet No 988 entitled Pregnancy of unknown location and have open access to the Gynaecology ward (stated on discharge letter / Viewpoint USS report) Arrange repeat serum βhcg in EPU (or gynaecology ward at weekends) in 48 hours If the woman is symptomatic, refer to EGU / gynaecology ward for senior doctor review. Consider admission for observation pending serial bhcg or laparoscopy if clinical signs deteriorate Page 1 of 8

2 At repeat βhcg, follow PUL algorithm (Fig 1) Outcome The four possible outcomes of Pregnancy of Unknown location are: Failing PUL (Miscarriage or small ectopics that resolve spontaneously) - serial βhcg levels fall >50% Early intrauterine pregnancy (too small to visualise on initial scan) - serial βhcg levels rise >63%* Ectopic pregnancy - serial βhcg levels show suboptimal rise / fall** Persistent PUL (where no evidence of trophoblastic disease) - serial βhcgs fail to fall *There can be a suboptimal rise in βhcgs in early ongoing intrauterine pregnancies. The diagnosis of failing intrauterine pregnancy is made on USS NOT suboptimal rise of βhcg **13-21% of ectopic pregnancies can have a >63% rise in serial βhcg. Ensure a rescan is arranged when βhcg is >2000iu/l Serum βhcg and USS The defined level of βhcg above which a gestation sac of an intrauterine pregnancy can be seen on TVS (discriminatory zone) has been widely evaluated and there is a range of recommended values between iu/l. The variation depends upon hcg assay techniques, quality of USS equipment and operator experience. Moreover in multiple pregnancies the hcg levels should be interpreted with caution as they are higher. We use a cut off of 2000iu/l. Serial βhcgs The pattern of rise or fall of serial βhcg levels is useful in distinguishing between PULs that will develop into failing PULs from intrauterine and ectopic pregnancies. However they need to be interpreted with caution as the groups aren t mutually exclusive. Serial βhcgs that rise >63% suggest an intrauterine pregnancy, however 13-21% of ectopic pregnancies can have a >63% rise in serial βhcg. Suboptimal rise of βhcg suggest an ectopic pregnancy, however there can be a suboptimal rise in bhcgs in up to 15% early ongoing intrauterine pregnancies. Intervention for an hcg rise of less that 63% in 2 days (a practise previously supported by data) may result in the interruption of a viable pregnancy. The diagnosis of failing intrauterine pregnancy is made on USS NOT suboptimal rise of βhcg. If the βhcg level falls by at least 50% in 48 hours, the most likely outcome is a failing PUL. Failing PUL includes ectopic pregnancy and thus the βhcg levels must be repeated weekly until negative. Ruptured ectopic pregnancies can occur even with declining or very low βhcgs. Rupture has even been reported with negative levels of serum βhcg Page 2 of 8

3 PUL Algorithm Positive pregnancy test TVS PUL (no EP or IUP seen) Clinical Assessment Asymptomatic Symptomatic Expectant management as outpatient with open access Senior doctor review Admit to ward. Consider laparoscopy Serum bhcg at 0 and 48 hours * Falling >50% Likely failing PUL Urine pregnancy test 14 days. If positive for review Ectopic pregnancy visualised (see EP guideline) Rise <63% or fall <50%?ectopic pregnancy Serial bhcg until >2000 iu/l OR - 3 measurements showing suboptimal rise / fall or plateauing or fluctuating pattern Repeat TVS Negative TVS -?persisting PUL Discussion with consultant Consider MVA with follow up bhcgs or medical management (MT) Page 3 of 8 Rising >63% Likely IUP Intrauterinpregnancy Reassure, though warn still possibility of ectopic Repeat TVS 7-10 days or earlier if hcg >2000 Early IUP visualised No further action Key PUL pregnancy of unknown location IUP intrauterine pregnancy EP Ectopic pregnancy TVS transvaginal scan MT - methotrexate MVA manual evacuation uterus *Consider rescan at hours if PUL and initial serum bhcg >2000 iu/l

4 3. Monitoring compliance and effectiveness. Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Is the Diagnosis on USS findings box completed on the viewpoint database Outcome of PULs Miss Lisa Verity, Consultant O&G EGU / EPU databases Gynaecology dashboard Annually EGU / EPU MDT Dashboard Women s & Newborn Audit meeting EGU & EPU MDT Required changes to practice will be identified and actioned within 3 months. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 4 of 8

5 Appendix 1. Governance Information Document Title Date Issued/Approved: 13/06/2014 PREGNANCY OF UNKNOWN LOCATION (PUL) - CLINICAL GUIDELINE Date Valid From: 13/06/2014 Date Valid To: 13/06/2017 Directorate / Department responsible (author/owner): Miss Lisa Verity Consultant O&G Contact details: Brief summary of contents Suggested Keywords: Target Audience Executive Director responsible for Policy: All clinical staff working in the Division of women, children & sexual health to provide evidence based guidance in the management of pregnancies of unknown location PUL Pregnancy Unknown Location miscarriage ectopic RCHT PCH CFT KCCG Medical Director Date revised: 13/06/2014 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: New Document Obstetric & Gynaecology Directorate meeting Divisional Manager confirming approval processes Dr. Frances Keane Name and Post Title of additional signatories Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Not Required {Original Copy Signed} Internet & Intranet Clinical / Gynaecology Page 5 of 8 Intranet Only Ectopic pregnancy & miscarriage: Diagnosis and initial management in early pregnancy of ectopic pregnancy &

6 miscarriage. NICE clinical guideline 154. Dec 2012 Related Documents: Ectopic pregnancy & miscarriage: Diagnosis and initial management in early pregnancy of ectopic pregnancy & miscarriage. NICE clinical guideline 154. Dec 2012 List other guidelines & hyperlink guidelines in document library Training Need Identified? No Version Control Table Date Versio n No Summary of Changes Changes Made by (Name and Job Title) 10 Jun 14 V1.0 Initial Issue Lee Azancot Data Administrator [Please complete all boxes and delete help notes in blue italics including this note] All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 6 of 8

7 Appendix 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): PREGNANCY OF UNKNOWN LOCATION (PUL) - CLINICAL GUIDELINE Directorate and service area: Is this a new or existing Policy? Gynaecology New Name of individual completing Telephone: assessment: Miss Lisa Verity 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? 2. Policy Objectives* As above All clinical staff working in the Division of women, children & sexual health to provide evidence based guidance in the management of pregnancy of unknown location (PUL) 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? As above See section 3 All obs & gynae patients No b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Page 7 of 8

8 Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. Yes No x 9. If you are not recommending a Full Impact assessment please explain why. Signature of policy developer / lead manager / director Date of completion and submission Names and signatures of members carrying out the Screening Assessment 1. Miss Lisa Verity 2. Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date Page 8 of 8

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