Guidelines on management of pregnancy of unknown location (PUL)
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1 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 1 Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Guidelines on management of pregnancy of unknown location (PUL) Contact Name and Job Title (author) Dr. Shilpa Deb Consultant Obstetrician and Gynaecologist Directorate & Speciality Family Health Obstetrics and Gynaecology Date of submission March 2016 Date on which guideline must be reviewed (this should be one to three years) Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) March 2021 Patients with an early pregnancy of 12 weeks Abstract This guideline is aimed at management of women with an early pregnancy when the location of pregnancy is not known. Key Words Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-5) 1a meta analysis of randomised controlled trials 1b at least one randomised controlled trial 2a at least one well-designed controlled study without randomisation 2b at least one other type of well-designed quasiexperimental study 3 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Consultation Process Ultrasound, early pregnancy, intra-uterine, ectopic, hcg Literature review, evidence ranging from 1 to 5. Peer-reviewed by the risk management group Risk Management Group Consultant Gynaecologists Ward Sisters Gynaecology Nurse Specialists Practice Development Matron
2 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 2 Target audience All the medical, nursing and admin staff involved with emergency gynaecology This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.
3 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 3 Introduction In the absence of either an intra- or extra-uterine pregnancy or retained products of conception in a woman with a positive pregnancy test, the pregnancy should be described as, pregnancy of unknown location. Even with expert use of TVS (Transvaginal Scanning) using agreed criteria, it may not be possible to confirm if a pregnancy is intrauterine or extra-uterine in 8 31% of cases at the first visit. These women should be classified as having a pregnancy of unknown location. In specialised scanning units, the overall incidence of pregnancy of unknown location is as low as 8 10%. In cases of known intrauterine pregnancy, viability will be uncertain in approximately 10% of women at their first EPAU (Early Pregnancy Assessment Unit) visit. The number of cases falling into these two groups can be kept to a minimum by using a thorough and critical approach to TVS in conjunction with strict diagnostic criteria. The sonographer should record whether an apparently empty sac is eccentrically placed in the fundus, whether it exhibits a double-ring pattern, and so on. These findings will help to delineate whether this is likely to be an intra- or extra-uterine pregnancy. At levels above 1500 iu/l, an ectopic pregnancy will usually be visualised with TVS. However, the importance of levels that plateau below 1000 iu/l must be recognised. In these cases, an ectopic pregnancy and miscarriage are both possible outcomes. The potential for rarer
4 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 4 diagnoses, such as gestational trophoblastic disease or cranial germ cell tumour, must be considered although, in these cases, serum hcg (Human Chorionic Gonadotropin) levels are likely to be greater than 1000 IU/l. With a history and TVS findings suggestive of complete miscarriage, a 5.9% incidence of ectopic pregnancy has been reported and therefore the importance of performing serial hcg. Anti D immunoglobulin should be administered when a surgical recourse (ERPC - Evacuation of Retained Products of Conception / laparoscopy) is taken to managing pregnancy of unknown location. Guidelines for management of Inconclusive Scan Result after the Initial Visit to EPU using Serum hcg and TVS hcg IU/L Ultrasound Pattern of change Of hcg level after 48 hours Management 1000 No intrauterine sac No Adnexal mass No fluid in POD No symptoms hcg rise > 66% or doubled If hcg>1000 repeat ultrasound or If hcg < 1000 repeat hcg >1000 No intrauterine sac 1. No adnexal mass No fluid POD No symptoms Repeat hcg and repeat ultrasound 2 days later A. Falling hcg Serial hcg levels until hcg <20 B. Rising Or Laparoscopy (if plateauing hcg symptomatic) Or x 3 Methotrexate (if Diagnosis: asymptomatic) Ectopic or PUL (refer to guidelines on ectopic pregnancy)
5 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 5 2. Suspicious adnexal mass <3.5cm No fluid POD Repeat hcg and repeat ultrasound 2 days later Asymptomatic A. Falling hcg Serial hcg levels until hcg <20 B. Rising/ plateauing hcg x 3 Laparoscopy +/-D&C or Methotrexate 3. Ad.Mass 3.5cm Or Fluid POD Or Symptomatic >2400 No intrauterine sac Adnexal findings +/- Asymptomatic Fluctuating x3 Diagnosis: Ectopic Or PUL Laparoscopy Laparoscopy or Methotrexate
6 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 6 Guidelines on management of pregnancy of unknown location (PUL) Positive Urine Pregnancy Test Transvaginal ultrasound scan PUL / Inconclusive scan Haemodynamically stable Pain free Haemodynamically stable In pain Haemodynamically unstable In pain Expectant management Admit and Serum hcg Serum hcg at 0 & 48 hrs Consider laparoscopy Consider laparotomy >66% increase in Serum hcg 0-48 hours <66% increase or <15% decrease in Serum hcg 0-48 hrs >15% decrease in Serum hcg 0-48 hrs? Intra Uterine Pregnancy? Ectopic pregnancy? Failing PUL Rescan in 1 week to confirm pregnancy location Serum hcg in 48 hrs. Rescan if hcg >1000 IU/L Repeat serum hcg in 1 week to confirm failing preg Early IUP Ectopic pregnancy PUL Rescan 2 weeks to confirm viability Management as clinically indicated Repeat hcg now and 48 hrs later Consider weekly hcg monitoring until < 25 IU/L If no pregnancy seen on repeat scan and suboptimal rise in hcg, consider methotrexate (refer to guidelines on medical management of ectopic pregnancy)
7 Emergency Gynaecology SSU_S.Deb Guidelines on Management of PUL 7 References Banerjee S, Aslam N, Woelfer B, Lawrence A. Elson J, Jurkovic D. Expectant management of pregnancies of unknown location:a prospective evaluation of methods to predict spontaneous resolution of pregnancy. BJOG 2001;108: Condous G, Okaro E, Bourne T. The conservative management of early pregnancy complications: a review of the literature. Ultrasound Obstet Gynecol 2003;22: Condous G, Okaro E, Khalid A, Bourne T. Do we need to follow up complete miscarriages with serum human chorionic gonadotrophin levels? BJOG 2005;112: Hahlin M, Thorburn J, Bryman I. The expectant management of early pregnancy of uncertain site.humreprod 1995;10: Jauniaux E, Johns J, Burton GJ. The role of ultrasound imaging in diagnosing and investigating early pregnancy failure. Ultrasound Obstet Gynecol 2005;25: NICE Guideline CG154, Ectopic pregnancy and miscarriage Diagnosis and initial management in early pregnancy of ectopic pregnancy and miscarriage. December Royal College of Obstetricians and Gynaecologists. Use of Anti-D Immunoglobulin for Rh Prophylaxis. Guideline No. 22. London: RCOG; Royal college of Obstetrician and Gynaecologist. The management of early pregnancy loss. Guideline No. 25, London: RCOG; Royal college of Obstetrician and Gynaecologist. The management of tubal pregnancy. Guideline No. 21, London: RCOG; 2004, reviewed 2010.
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