ISUOG Practice Guidelines: point‐of‐care ultrasound in obstetrics and gynecology

Abstract

The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) is a scientific organization that encourages sound clinical practice, and high-quality teaching and research, related to diagnostic imaging in women's healthcare. The ISUOG Clinical Standards Committee (CSC) has the remit to develop Practice Guidelines and Consensus Statements as educational recommendations that provide healthcare practitioners with a consensus-based approach, from experts, for diagnostic imaging. They are intended to reflect what is considered by ISUOG to be the best practice at the time at which they are issued. Although ISUOG has made every effort to ensure that Guidelines are accurate when issued, neither the Society nor any of its employees or members accepts any liability for the consequences of any inaccurate or misleading data, opinions or statements issued by the CSC. The ISUOG CSC documents are not intended to establish a legal standard of care because interpretation of the evidence that underpins them may be influenced by individual circumstances, local protocol and available resources. Approved Guidelines can be distributed freely with the permission of ISUOG ([email protected]). The integration of point-of-care ultrasound (PoCUS) has transformed clinical practice by offering an affordable, portable and directly accessible diagnostic tool for bedside use. Unlike screening, targeted or referral ultrasound1-3, PoCUS focuses on answering specific clinical questions or guiding procedures in real time4. PoCUS has been widely adopted in emergency medicine5-7, and its use has expanded to various specialties, including obstetrics and gynecology (Ob/Gyn), in which rapid assessment is critical for effective patient care. Initially introduced in the 1980s with portable machines, PoCUS has proved particularly valuable in low-resource settings8-12, where access to advanced equipment and highly trained operators is limited. Although well-designed studies on the effectiveness of PoCUS in Ob/Gyn are scarce, interest in its use has grown in high-income countries due to its potential to expedite care, improve provider confidence and reduce patient anxiety13, 14. Unlike conventional ultrasound examination performed by a sonographer or other specialist, PoCUS is a readily accessible tool for all providers involved in the care of patients with Ob/Gyn emergencies15, 16, including emergency physicians5-7, family physicians11, residents12 and midwives10. Despite its advantages, PoCUS is not a replacement for comprehensive ultrasound examination performed by a specialist, but rather a complementary tool for addressing Ob/Gyn emergencies, guiding procedures and enhancing clinical decision-making. However, international guidelines are needed to standardize its applications and clarify its benefits and limitations in Ob/Gyn, ensuring optimal patient outcomes across different healthcare settings worldwide. The objective of this Guideline is to provide recommendations regarding the appropriate use of PoCUS in Ob/Gyn in various clinical scenarios encountered by different healthcare professionals (e.g. emergency physicians, obstetrician-gynecologists, midwives, residents and family physicians). The target population consists of patients with Ob/Gyn complications or those needing an interventional procedure for which an immediate bedside sonographic evaluation is helpful. The quality of evidence and the strength of the recommendations were graded using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology17-19. This Guideline is reported in accordance with the Appraisal of Guidelines for Research and Evaluation II (AGREE II) Instrument20. Full details of the methodological and developmental process are provided in Appendices S1–S12. Briefly, the Promoting Committee of this Guideline appointed two working groups (one for obstetrics and one for gynecology) and a multidisciplinary panel. One member of the Promoting Committee, a methodologist, oversaw the process. The multidisciplinary, multistakeholder panel included a clinician expert in the field of ultrasound in Ob/Gyn, a representative from a low-income country, a midwife, a family physician, two emergency physicians and a patient representative (Appendix S2). All participants involved in the development of this Guideline gave a signed declaration specifying any potential conflicts of interest. Thirteen clinical questions (nine obstetric and four gynecological) were defined following the Patients, Intervention, Comparison, Outcomes (PICO) framework19(Appendix S3). The systematic literature search was developed by an experienced professional librarian. The search results and the selection process were summarized using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020)21 flow diagram (Appendix S4). The two working groups provided the panel with draft recommendations. The panel members were asked to vote on whether they agreed with each recommendation and to express their opinion about the potential conflict of the intervention with the values and expectations of patients, the benefit–risk balance, related costs and/or the use of resources, potential effect on equity of healthcare, acceptability to patients and healthcare decision-makers (at the local level) and feasibility of its application in every context worldwide (Appendices S9 and S10). An adapted version of the GRADE Evidence to Decision framework was used for discussion within the panel to assess domains that may have impacted the formulation of each recommendation22. The development of recommendations followed the GRADE methodology23, considering the balance between the desirable and undesirable effects of various intervention alternatives. When the balance was clearly either in favor of or against the intervention, the recommendation was deemed ‘strong’ (strong positive or strong negative recommendation). In case of uncertainty in evaluating this balance, the panel formulated a ‘conditional’ recommendation in favor of or against the treatment (conditional positive or conditional negative recommendation). However, recommendations, even when considered ‘strong’, should not be considered mandatory standards because their application may be influenced by local resources, different healthcare systems and other factors. When an ultrasound evaluation is performed in early pregnancy, it should include assessment of viability by identification of a fetal heartbeat, and confirmation of the intrauterine location of the pregnancy1. PoCUS can provide timely and valuable information for the management of several complications that may arise during the first trimester of pregnancy and in emergency/urgent cases, improving the identification of pregnancy complications and reducing hospitalization (Italian Society of Ultrasound in Obstetrics and Gynecology (SIEOG)13 high-quality guideline; Society of Obstetricians and Gynaecologists of Canada (SOGC)14 high-quality guideline). PoCUS can be used to assess the presence of an intrauterine pregnancy and its viability in patients with early pregnancy complications such as threatened miscarriage, incomplete miscarriage, missed miscarriage or ectopic pregnancy24. It has been estimated that the visualization of an intrauterine pregnancy with PoCUS can rule out an ectopic pregnancy with a sensitivity of 97% (95% CI, 92–99%), a specificity of 71% (95% CI, 60–80%) and a negative predictive value of 99.96% (95% CI, 99.6%–100%)24. A systematic review and meta-analysis examined the impact of PoCUS, performed by emergency physicians at the time of admission, on the length of stay in the clinic or health department, in comparison to comprehensive ultrasound25. There was a strong association between PoCUS in the evaluation of symptomatic women in early pregnancy and decreased length of stay in patients with visualization of an intrauterine pregnancy (mean reduction of 73.8 (95% CI, 49.1–98.6) min)25. Question 1 Could PoCUS improve the care/outcome of symptomatic patients (abdominal pain or bleeding) who present emergently to a clinic or health department in the first trimester of patients in the first trimester of pregnancy who present to a clinic or health department ultrasound and/or Clinical examination of of of management of early pregnancy complications of hospitalization of length of stay in the clinic or health department of 1 PoCUS is in symptomatic patients who present emergently to a clinic or health department in the first trimester of on high-quality members to with the strong positive recommendation by the working However, the recommendation was in of by of the panel members regarding feasibility of this intervention in every context worldwide. All members agreed that the balance between the desirable and undesirable effects was clearly in favor of the intervention, a strong positive during the it that is a of literature on this a is needed to the impact of PoCUS in symptomatic patients who present emergently to a clinic or health department in the first trimester of Question Could PoCUS improve the care/outcome of pregnancy in patients with who present emergently to a clinic or health patients who present to a clinic or health department with ultrasound and/or Clinical examination of of of of of the length of stay in the clinic or health department of or of obstetric complications of PoCUS is in patients with who present emergently to a clinic or health department, particularly to improve the of and on high-quality The its with the using and its should be at the fetal ultrasound In patients with timely can be to rule out or a particularly has been sonographic bedside ultrasound assessment of location may reduce the of of the high-quality guideline). The for and on care evaluation of the by ultrasound in patients with and high-quality guideline). high-quality in patients emergently with in the trimester of pregnancy, PoCUS for the assessment of location should be performed when an trained clinician is not available for a diagnostic sonographic is with and for the of a or a in high-quality guideline). 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