2025+ISUOG实践指南：产科和妇科的床旁超声检查

INTRODUCTION

The integration of point-of-care ultrasound(PoCUS) has transformed clinical practice by offering an affordable,portable and directly accessible diagnostic tool for bedside.Unlike screening, targeted or referral ultrasound1 ${ }^{3-}$ ,PoCUS focuses on answering specific clinical questions or guiding procedures in real time ${ }^{4}$ . PoCUS has been widely adopted in emergency medicine ${ }^{5-7}$ , 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 settings ${ }^{8-12}$ , where access to advanced equipment and highly trained oper-ators 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 confi-dence and reduce patient anxiety ${ }^{13,14}$ . 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 emergencies 15,16, including emergency physicians 5-7, fam-ily physicians11, residents12 and midwives10. Despite its advantages, PoCUS is not a replacement for comprehen-sive 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 ben-efits and limitations in Ob/Gyn, ensuring optimal patient outcomes across different healthcare settings worldwide.

SCOPE AND PURPOSE

The objective of this Guideline is to provide recom-mendations regarding the appropriate use of PoCUS in Ob/Gyn in various clinical scenarios encountered by dif-ferent healthcare professionals(e.g. emergency physicians,obstretrician-gynecologists, midwives, residents and fam-ily physicians). The target population consists of patients with Ob/Gyn complications or those needing an inter-ventional procedure for which an immediate bedside sonographic evaluation is helpful.

METHODOLOGY

The quality of evidence and the strength of the recom-mendations were graded using the Grading of Recom-mendations, 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 partic-ipants involved in the development of this Guideline gave

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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) frame-work19(Appendix S3). The systematic literature search was developed by an experienced professional librarian.The search results and the selection process were sum-marized using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA 2020)21 flow dia-gram(Appendix S4). The two working groups provided the panel with draft recommendations. The panel mem-bers 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 for-mulation of each recommendation ${}^{22}$ . The development of recommendations followed the GRADE methodology23,considering the balance between the desirable and unde-sirable 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.

# RECOMMENDATIONS IN OBSTETRICS

Recommendation 1

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 man-agement of several complications that may arise during the first trimester of pregnancy and in emergency/urgent cases, improving the identification of pregnancy com-plications 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 bleed) who present emergently to a clinic or health department in the first trimester of pregnancy?| |---| |P: Symptomatic patients in the first trimester of pregnancy who present to a clinic or healthy department in the first trimester of pregnancy?| |P: Symptomatic patients in the first trimester of pregnancy who present to a clinic or healthy department| |C: Clinical examination| |O: Outcome 1: Reduction of maternal mortality Outcome 2: Reduction of maternal morbidity Outcome 3: Rate of surgical vs medical management Outcome4: Detection of early pregnancy complications Outcome 5: Reduction of hospitalization Outcome 6: Reduction of length of stay in the clinic or health department Outcome 7: Reduction of maternal anxiety| |Recommendation 1 PoCUS is recommended in symptomatic patients who present emergently to a clinic or health department in the first trimester of pregnancy. STRONG POSITIVE RECOMMENDATION(based on high-quality guidelines)|

# Justification for the recommendation

Panel members voted unanimously to‘completely agree’with the strong positive recommendation proposed by the working group. However, the recommendation was rediscussed in light of concerns raised by 28.6% 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, thus confirming a strong positive recommendation. Moreover, during the discussion, it emerged that there is a lack of recent literature on this topic, suggesting a research priority.

Recommendations for research

Future research is needed to investigate the impact of PoCUS in symptomatic patients who present emergently to a clinic or health department in the first trimester of pregnancy.

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Recommendation 2

Question 2

Could PoCUS improve the care/outcome of pregnancy in patients with antepartum hemorrhage(≥24+0 weeks' gestation) who present emergently to a clinic or health department?

P: Pregnant patients who present to a clinic or health department with antepartum hemorrhage

I. Pelvic ultrasound(transabdominal and/or transvaginal)

C: Clinical examination

O: Outcome 1: Reduction of maternal mortality

Outcome 2: Reduction of maternal morbidity

Outcome 3: Reduction of perinatal mortality

Outcome 4: Reduction of perinatal morbidity

Outcome 5: Reduction of the length of stay in the clinic or health department

Outcome 6: Detection of low-lying placenta, placenta previa or abruption

Outcome 7: Detection of obstetric complications

Outcome 8: Reduction of maternal anxiety

Recommendation 2

PoCUS is suggested in patients with antepartum hemorrhage(≥24+0 weeks' gestation) who present emergently to a clinic or health department, particularly to improve the detection of low-lying placenta, placenta previa and placental abruption.

CONDITIONAL POSITIVE RECOMMENDATION(based on high-quality guidelines)

The placental location, its relationship with the internal cervical osu (usually using transabdominal ultrasound)and its appearance should be assessed at the routine mid-trimester fetal ultrasound scan2. In patients with antepartum hemorrhage, timely placental localization can be important to rule out placenta previa or a low-lying placenta, particularly if there has been no prior sono-graphic examination14. Moreover, preoperative bedside ultrasound assessment of placental location may reduce the risks of intraoperative transection of the placenta(SOGC26, high-quality guideline). The National Institue for Health and Care Excellence(NICE) guideline on ante-natal care recommends evaluation of the placental site by ultrasound in pregnant patients with unexplained vaginal bleeding and unknown placental position(NICE27,high-quality guideline). Another high-quality guideline(SIEOG13) recommends that, in patients presenting emer-gently with antenatal bleeding in the third trimester of pregnancy, PoCUS for the assessment of placental location should be performed when an adequately trained clinician is not available for a diagnostic sonographic examination.Transabdominal sonography is associated with high false-positive and false-negative rates for the detection of a low-lying placenta, placenta previa or a placental abruption in these circumstances(SOGC26, high-quality guideline). The use of the transvaginal approach provides a better definition of the placental location in relation to the cervix, especially in cases of suspected posterior placenta previa, and is, therefore, the prefered imaging modality, when feasible3. Transvaginal ultrasound had

a 99% positive predictive value, 98% negative predictive value and 2.3% false-negative rate for diagnosing placenta previa in women in whom this was suspected on transab-dominal ultrasound in the second or early third trimester3.As reported in a recent systematic review28, PoCUS has a substantial impact on the management and clinical care of pregnant patients, including improved diagnosis of high-risk and complicated pregnancies, appropriate referral to skilled birth attendants, more deliveries in healthcare facilities and a reduction in maternal and neonatal mortality in low- and middle-income countries.High-risk pregnancies, including those complicated by placenta previa, can be identified by appropriately trained midwives and nurses during the prenatal period and labor28. Task shifting for PoCUS services improved the accuracy of diagnosis when compared to clinical examination only; midwives applying PoCUS modified their diagnosis in around 7% of cases and changed their clinical decision in 17% following PoCUS examination28.However, it should be taken into account that placental localization may require in certain circumstances a level of expertise beyond the aim of PoCUS13.

Justification for the recommendation

More than 85% of the panel members voted in complete agreement with the conditional positive recommendation proposed by the working group. Although they agreed that the balance between desired and undesired effects clearly favors the intervention, the recommendation was not proposed to be strong due to the following:(1) it is necessary to establish a training program for operators;and(2) while a transvaginal approach is preferred when-ever feasible, this might be limited by unavailability of a transvaginal probe and by the practitioner's lack of skill.

Question 3

Question 3

Could PoCUS, performed in pregnancies close to term(from 37 weeks' gestation) to confirm fetal presentation, improve pregnancy outcome?

P: Pregnant patients at term(≥37 weeks' gestation)

I: Sonographic evaluation of fetal presentation

C: Clinical examination

O: Outcome 1: Reduction of maternal morbidity

Outcome 2: Reduction of perinatal mortality

Outcome 3: Reduction of perinatal morbidity

Outcome 4: Reduction in Carewas arean section rate

Outcome 5: Rate of vaginal twin delivery

Recommendation 3

PoCUS is recommended in pregnancy close to term to confirm fetal presentation only when it is undetermined at the clinical examination.

STRONG POSITIVE RECOMMENDATION(based on high-quality guidelines)

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ISUOG guidelines on the performance of third-trimester obstetric ultrasound examination recommended that a scan for fetal presentation close to or at the time of delivery should be considered if resources are available, taking into account that it can reduce the risk of undiagnosed breech presentation3. However, in countries where ultrasound examination at this stage of pregnancy is not feasible,an assessment for fetal presentation using Leopold's maneuvers should be performed at or beyond 36 weeks of gestation, as fetal presentation can influence peri- and intrapartum management(Belgian Health Care Knowl-edge Centre(KCE)29, high-quality guideline). When malpresentation is suspected during a clinical examina-tion or Leopold's maneuvers, a sonographic examination should be considered to confirm the fetal presentation(KCE29, high-quality guideline; SIEOG13, high-quality guideline; NICE27, high-quality guideline; Australian Government30, high-quality guideline). PoCUS is impor-tant in twin pregnancies and in patients with a high body mass index in whom clinical examination is particularly limited14. The rationale for these recommendations is that timely determination of non-cephalic presentation is critical for optimal management. A high-quality guideline of The Royal Australian and New Zealand College of Obstetricians and Gynaecologists(RANZCOG)31 recommends, if practicable, performing PoCUS when non-cephalic presentation is first diagnosed in labor.In this scenario, the obstetrician should discuss with the woman the decision regarding emergency Cesarean section or proceeding with attempted vaginal delivery,explaining the risks and benefits of each approach according to her individual circumstances. However, the evidence for maternal and/or fetal outcomes associated with the mode of delivery of a non-cephalic fetus is incon-sistent(Australian Government30, high-quality guideline; RANZCOG31, high-quality guideline). Some guidelines recommend that after 37 weeks of gestation, external cephalic version(ECV) should be offered to patients with an uncomplicated pregnancy with a singleton fetus but non-cephalic presentation(Australian Government30,high-quality guideline; RANZCOG31, high-quality guideline. Identifying non-cephalic presentation at around 36 weeks' gestation enables timely discussion of ECV and referral to a health professional with expertise in this procedure or referral to a health professional and center with expertise in vaginal non-cephalic birth31.ECV is associated with a reduction in the rate of Cesarean section for non-cephalic presentation30.

Justification for the recommendation

More than 85% of the panel members voted in complete agreement with the strong positive recommendation initially proposed by the working group. Nonetheless,during the panel discussion, the formulation of this recommendation was changed to specify more precisely that PoCUS is recommended in pregnancies near term to confirm fetal presentation only when the fetal presentation remains unclear after clinical examination.

Recommendation 4

|Question 4 Could PoCUS, performed prior to instrumental vaginal delivery to determine fetal head position,improve the pregnancy outcome?| |---| |P: Pregnant patients with protracted second stage of labor| |I: Sonographic evaluation of fetal head position| |C: Clinical examination| |O: Outcome 1: Reduction of maternal morbidity| |Outcome 2: Reduction of neonatal morbidity| |Outcome 3: Reduction of neonatal mortality| |Outcome 4: Reduction in Cesarean section rate| |Outcome 5: Success rate of instrumental vaginal delivery| |Outcome 6: Reduction of decision-to-delivery interval| |Outcome 7: Reduction of maternal anxiety| |Recommendation 4 PoCUS is suggested prior to instrumental vaginal delivery to determine fetal head position in cases of uncertainty at clinical examination.| |examination.| |CONDITIONAL POSITIVE RECOMMENDATION(based on high- and moderate-quality guidelines)|

Clinicians should be aware that sonographic assessment of the fetal head position prior to instrumental vaginal birth is more reliable than a clinical examination(Royal College of Obstetricians and Gynaecologists(RCOG)32,high-quality guideline; ISUOG33,moderate-quality guide-line). A randomized controlled trial showed that ultra-sound assessment in addition to digital examination prior to instrumental vaginal delivery is significantly more accu-rate compared with digital examination alone in the diagnosis of fetal head position(incorrect diagnosis, 1.6%in ultrasound group and 20.2% in digital-examination group)33. Fetal head direction has been shown to predict the outcome of instrumental vaginal delivery(ISUOG33,moderate-quality guideline). A high-quality guideline addressing recommendations on intrapartum ultrasound suggests performing a sonographic examination during the second stage of labor when an operative vaginal delivery is indicated, in the absence of emergency circum-stances, if the operator is uncertain of the position of the fetal occiput(SIEOG13, high-quality guideline).

Justification for the recommendation

The panel agreed that this clinical question is specific to the application of PoCUS for practitioners within the field of Ob/Gyn rather than being universally applicable across all disciplines. More than 85% of the panel members voted in complete agreement with the conditional positive recommendation proposed by the working group. However, the panel members acknowledged that all evidence supporting the recommendation is drawn from guidelines that are not specific to PoCUS, but rather pertain to‘ultrasound in labor’. Therefore, the opinion of the panel was that this specific application of ultrasound should be considered PoCUS when it represents an assessment made to guide a clinical decision.

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Recommendations for research

Future research is needed to investigate the impact of PoCUS prior to instrumental vaginal delivery. Moreover,there is a need to define specific training for operators that would allow for wider use of PoCUS in labor.

Recommendation 5

|Question 5| |---| |Could PoCUS improve the pregnancy outcome in patients with uncertainty regarding fetal heart activity?| |P: Pregnant patients with uncertainty regarding fetal heart activity| |I: Sonographic evaluation of fetal heart activity C: Auscultation| |O: Outcome 1: Help in positioning of the cardiotocographic sensor| |Outcome 2: Differentiating maternal from fetal heart rate| |Outcome 3: Reduction of perinatal mortality| |Outcome 4: Reduction of perinatal morbidity Outcome 5: Reduction of maternal anxiety| |Recommendation 5| |PoCUS is suggested in pregnant patients with uncertainty regarding fetal heart activity, particularly before 28 weeks' gestation.| |CONDITIONAL POSITIVE RECOMMENDATION(based on high-quality guidelines)|

Assessment of viability, defined by identification of a fetal heartbeat, is achieved most easily using ultrasound1-3.Each pregnant patient should be aware of the baby's normal movement patterns and contact a healthcare pro-fessional if there are concerns about decreased or absent fetal movement29. Successful detection of the fetal heart beat by auscultation confirms fetal viability; however, it does not guarantee that the pregnancy will continue with-out complications, and it is unlikely to provide detailed information on the fetal heart rate such as decelerations or variability(Australian Government30, high-quality guideline). Although there is no evidence of the psycho-logical benefits of auscultation for the mother, it may be comforting, reduce anxiety and increase maternal-fetal bonding. However, it is unlikely that the fetal heart rate will be audibleable prior to 28 weeks if a Pinard stethoscope is used, and attempts to auscultate the fetal heartbeat prior to this time may be unsuccessful, leading to maternal anxiety in pregnancies that are in fact uncomplicated.In cases of suspected fetal demise, PoCUS to detect fetal cardiac activity can determine whether the fetus is alive14.If viability is confirmed, the assessment can rapidly alleviate parental anxiety. If fetal demise is confirmed,the assessment can reduce unnecessary interventions and guide further management. PoCUS has also been recommended when identification of fetal heart activity by a cardiotocographic sensor proves difficult, to identify the correct placement of the sensor and to evaluate the fetal heart rate quickly(SIEOG13, high-quality guideline).

Justification for the recommendation

More than 85% of the panel members voted in complete agreement with the conditional positive recommendation proposed by the working group. Taking into account the possible impact of prompt identification of fetal viability(or demise) on clinical management and maternal anxiety, the panel recommended checking the presence of fetal heart activity by ultrasound, when indicated and if feasible. The choice between auscultation and PoCUS will depend on the gestational age, national and local resources and other setting-specific considerations.

Recommendation 6

|Question 6 Could PoCUS, performed in late-term or post-term pregnancy for the quantitative assessment of the amniotic fluid, improve the pregnancy outcome?| |---| |P: Late-term and post-term pregnancy| |I: Sonographic evaluation of amniotic fluid volume| |C: Clinical examination| |O: Outcome 1: Reduction of perinatal morbidity| |Outcome 2: Reduction of perinatal mortality| |Outcome 3: Reduction in Cerinatal mortality| |Outcome 4: Induction rate| |Outcome 4: Induction rate| |Recommendation 6 PoCUS is suggested in late-term and post-term pregnancy for the quantitative assessment of amniotic fluid.| |CONDITIONAL POSITIVE RECOMMENDATION(based on high-quality guidelines)|

'Term pregnancy' is defined as a pregnancy that has reached 37+0 to 41+6 weeks of gestation. Late-term pregnancy is defined as one that has reached 41+0 to 41+6 weeks of gestation, while‘post-term pregnancy’or‘prolonged pregnancy’ refers to one that is at or beyond 42+0 weeks of gestation34. Recommendations regarding assessment of amniotic fluid in term or late-term pregnancy are not consistent among different guidelines. The amniotic fluid volume can be assessed semiquantitatively using either the amniotic fluid index(AFI) or the deepest vertical pocket(DVP). The technique for measuring amniotic fluid pockets has been described in the ISUO guidelines on the routine mid-trimester2 and third-trimester3 scans. The DVP is preferred over the AFI for diagnosing isolated oligohydramnios, as it is associated with a lower rate of induction of labor,with similar perinatal outcome3. Routine measurement of amniotic fluid volume is not recommended for fetal assessment in patients with an uncomplicated pregnancy at a gestational age of less than 41 weeks29. Antenatal monitoring, including at least an assessment of amniotic fluid volume, is recommended between 41 and 42 weeks's gestation(SOGC35, high-quality guideline). Another guideline recommends sonographic assessment of the DVP as part of the clinical monitoring of post-term pregnancies(SIEOG13, high-quality guideline). For

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patients who decline induction of labor after 42 weeks of gestation, it is advised to enhance antental monitoring,including sonographic assessment of the DVP30. Increased fetal and maternal monitoring aims to identify cases at risk of adverse outcome and ensure timely induction of labor when indicated(e.g. oligohydramnios).

Justification for the recommendation

The working group initially proposed a strong posi-tive recommendation for this application of PoCUS,considering the high level of evidence supporting the recommendation. However, only 43% of the panel voted in complete agreement. During the panel discussion,concerns emerged regarding the benefit-risk balance,costs and use of resources, feasibility in every context worldwide and equity in healthcare of this intervention.Therefore, it was decided unanimously to make a conditional positive recommendation.

Recommendation 7

|Question 7 Could PoCUS, performed in pregnant patients who present emergently to a clinic or health department, improve the pregnancy outcome?| |---| |P: Pregnant patients who present emergent to a clinic or health department with symptoms of preterm labor, improve the pregnancy outcome?| |P: Pregnant patients who present emergent to cervical length C: Clinical examination| |O: Outcome 1: Reduction of perinatal morbidity| |Outcome 2: Reduction of perinatal mortality| |Outcome 3: Reduction of hospitalization| |Outcome 4: Reduction of the length of stay in the clinic or health department| |Outcome 5: Reduction of maternal anxiety|

Recommendation 7

PoCUS for the measurement of cervical length is suggested in pregnant patients who present emergently to a clinic or health department with symptoms of preterm labor.

CONDITIONAL POSITIVE RECOMMENDATION(based on high-quality guidelines)

This recommendation refers exclusively to singleton pregnancies. Patients with a singleton pregnancy present-ing with symptoms of preterm labor(PTL), a condition also known as‘threatened preterm birth’, are seen frequently in clinical practice, and account for>15% of cases attending the obstetric triage units of tertiary care centers(ISUOG36, high-quality guideline). Furthermore,in 25-45% of patients with threatened PTL, there is a spontaneous resolution of symptoms, and 76% of these patients deliver at term. This discrepancy has an impact on management decisions, costs of treatment and, ultimately,pregnancy outcome. In recent years, sonographic assess-ment of cervical length and point-of-care biochemical markers have been evaluated as biophysical tools to aid in predicting which symptomatic patients are truly at an increased risk of PTL, in order to rationalize their care.

There is evidence to support the use of sonographic mea-surement of cervical length in patients at gestational ages between 24+0 and 36+6 weeks with symptoms of PTL,to identify those at high risk of imminent preterm delivery(ISUOG36, high-quality guideline). Thus, sonographic cervical-length measurement in patients with symptoms of PTL has been recommended by several guidelines,although with different gestational-age intervals and levels of recommendation: from 24 weeks' gestation onwards(SIEOG13, high-quality guideline); between 22+0 and 33+6 weeks(ISUOG36, high-quality guideline); and≥30 weeks(NICE37, high-quality guideline). Although sonographic measurement of cervical length seems to aid in the rationalization of PTL care, there is considerable variation among guidelines regarding the cervical length cut-off values and associated management protocols,such as decisions regarding hospitalization, corticosteroid administration, tocolysis and neuroprotection. The discussion regarding different cut-offs and management protocols is, however, beyond the scope of this Guideline and can be found elsewhere36.

Justification for the recommendation

The working group initially proposed a conditional positive recommendation for this application of PoCUS,considering the high level of evidence supporting the recommendation. However, only 57% of the panel voted in complete agreement. During the discussion, the panel agreed that this clinical question is specific to the applica-tion of PoCUS for practitioners within the field of Ob/Gyn,including gynecologists, mixwives and residents working in this area, rather than being universally applicable across all disciplines. Even though during the panel discussion concerns emerged regarding the benefit-risk balance,costs, equity in healthcare and feasibility of this interven-tion in every context worldwide, panel members agreed on a conditional positive recommendation. Although evidence exists to support the intervention, it is necessary to establish a training program for operators. Moreover,taking into account the fact that the sonographic measure-ment of cervical length is more accurate when conducted transvaginally compared with transabdominally, this approach is preferred whenever feasible.

Recommendation 8

Prenatal prediction of newborn birth weight lacks precision ${}^{38,39}$ . Both abdominal palpation and estimation of fetal weight(EFW) by ultrasound have demon-strated poor accuracy in predicting macrosomia and small-for-gestational age27. The use of sonographic EFW has some limitations: errors in single-parameter measurements are multiplied by using the formula for EFW computation; the accuracy of EFW is compromised by large intra- and interobserver variability, with errors in the range of 10-15% being common; and errors are relatively larger in the fetuses of greatest interest, i.e. those that are small-for-gestational age or large-for-gestational age40. The routine practice of symphysis-fundal height

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measurement is a simple, low-cost intervention and can alert physicians about potential fetal size abnormalities(NICE27, high-quality guideline). In cases in which fetal size abnormalities are suspected, sonographic assessment for fetal growth and wellbeing should be considered(NICE27, high-quality guideline).

Question 8 Could PoCUS, performed prior to delivery to determine the estimated fetal weight, improve the pregnancy outcome?

P: Pregnant patients prior to delivery

I: Sonographic evaluation of the estimated fetal weight C: Clinical examination

C: Clinical examination

O: Outcome 1: Reduction of maternal morbidity

Outcome 2: Reduction of perinatal morbidity

Outcome 3: Reduction of perinatal mortality

Outcome 4: Reduction in Cesarean section rate

Outcome 5: Reduction of instrumental delivery

Outcome 6: Reduction of decision-to-delivery interval

Recommendation 8

PoCUS is not suggested for estimating fetal weight before delivery when there are no suspected fetal size abnormalities based on clinical examination.

CONDITIONAL NEGATIVE RECOMMENDATION(based on high-quality guideline)

Justification for the recommendation

The working group initially proposed a conditional negative recommendation for this application of PoCUS.Panel members voted unanimously to‘completely agree’with this recommendation. In support of a conditional negative recommendation, the panel emphasized concerns regarding the benefit-risk balance, costs and use of resources and feasibility of this intervention in every context worldwide.

Recommendation 9

|Question 9 Could PoCUS, performed in pregnant patients with postpartum hemorrhage, improve the maternal outcome?| |---| |P: Pregnant patients with postpartum hemorrhage: √ Sonographic evaluation C: Clinical examination O: Outcome 1: Reduction of maternal morbidity Outcome 2: Reduction of maternal mortality Outcome 3: Diagnosis of etiology| |Outcome 4: Correct placement of intrauterine tamponade device| |Recommendation 9 PoCUS is suggested in pregnant patients with postpartum hemorrhage.| |CONDITIONAL POSITIVE RECOMMENDATION(based on high-quality guidelines)|

Primary postpartum hemorrhage(PPH) is bleeding that occurs in the first 24th after delivery, while secondary PPH is characterized by bleeding that occurs 24h to 12 weeks postpartum. Pelvic ultrasound examination is commonly performed in patients presenting with sec-ondary PPH to identify the presence of retained products of conception(RPOC). However, the reported perfor-mance of ultrasound in the detection of RPOC ranges widely(sensitivity, 44-94%; specificity, 16-92%)41-43.According to a high-quality guideline(RCOG44), pelvic ultrasound may help to exclude the presence of RPOC,although the diagnosis of RPOC is unreliable. It has been proposed that color flow Doppler imaging should be included in the evaluation of the uterus in patients with PPH, although there is no strong evidence to support its use45. The use of color flow Doppler may facilitate the diagnosis of enhanced myometrial vascularity(pseudoaneurysms and arteriovenous malformations),which are rare but may cause a secondary PPH46,47.However, according to RCOG, this evaluation does not achieve a level of evidence sufficient to recommend its use(RCOG44, high-quality guideline). Surgical evacuation of the uterus for RPOC is associated with the risk of uterine perforation(1.5%)48. It is, therefore, recommended that in cases of surgical evacuation of retained placental tissue, an appropriately trained clinician may consider performing uterine evacuation under direct sonographic guidance(RCOG44, high-quality guideline). In cases of uterine atony resistant to uterotonics, the insertion of an intrauterine chitosan tamponade balloon(Bakri balloon)or low-level suction device(Jada system) has been shown to be effective for treatment of PPH49. The correct position of the tamponade, balloon or other device can be confirmed sonographically. There is limited evidence on the use of ultrasound to assess the correct position of intrauterine tamponade devices, and there is no evidence that ultrasound performed in patients with PPH might improve maternal outcome. Thus, a high-quality guide-line(SIEOG13) recommended not to perform a pelvic ultrasound assessment routinely in patients with PPH.

Justification for the recommendation

Based on current guidelines, the working group initially proposed a conditional negative recommendation. How-ever, only 43% of the panel voted in complete agreement.During the panel discussion, some members argued in favor of the intervention on the basis that the benefits outweigh the drawbacks. Consequently, the panel agreed unanimously on a conditional positive recommendation.During the discussion, it emerged that there is a lack of recent literature on this topic, suggesting a research priority.

Recommendations for research

Future research is needed to investigate the impact of PoCUS in pregnant patients with PPH.

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RECOMMENDATIONS IN GYNECOLOGY

Recommendation 10

Question 10

Could PoCUS improve the care/outcome of symptomatic patients(abdominal pain, bleeding or abdominal distension) who present emergently to a clinic or health department?

P: Symptomatic patients(abdominal pain, bleeding or abdominal distension) who present emergently to a clinic or health department

I. Pelvic ultrasound

C: Clinical examination

O: Outcome 1: Reduction of morbidity

Outcome 2: Reduction of mortality

Outcome 3: Reduction of hospitalization

Outcome 4: Reduction of the length of stay in the emergency room

Outcome 5: Reduction in the need for other imaging tests

Outcome 6: Detection of gynecological diseases

Outcome 7: Reduction of patient anxiety

Recommendation 10

PoCUS is recommended in symptomatic patients(abdominal pain, bleeding or abdominal distension) who present emergently to a clinic or health department, to facilitate the identification of some medical conditions and to reduce the length of stay in the hospital.

STRONG POSITIVE RECOMMENDATION(based on high-quality guideline)

PoCUS can provide timely and valuable information for the management of symptomatic patients in the emergency department14. It is useful to evaluate the presence of an intrauterine pregnancy, and to identify RPOC and the presence of pelvic fluid and adnexal masses in suspected ectopic pregnancies. Additionally, in the hands of an experienced operator, PoCUS could be used to confirm the presence of abdominal and pelvic masses and ovarian cysts. A high-quality guideline(SIEOG13) recommends performing PoCUS in emergency/urgent symptomatic cases in order to facilitate the identification of some medical conditions and to reduce their length of stay in hospital. A recent systematic review of the literature50 aimed to explore the use of PoCUS in under-resourced healthcare settings, such as rural and remote locations in Australia and other countries. There was a broad range of ultrasound examination types performed across the different studies. Most studies used PoCUS for emergency department patients. Diagnostic accuracy and utility were generally high.

Justification for the recommendation

The panel members voted unanimously to‘completely agree' with the strong positive recommendation proposed by the working group. The recommendation was dis-cussed in light of the concerns raised by 71% of the panel

members regarding its feasibility in every context world-wide. However, during the discussion all panel members agreed that the balance between the desirable and unde-sirable effects is clearly in favor of the intervention. As a result, a strong positive recommendation was confirmed.

Recommendation 11

Question 11

Could PoCUS improve the care/outcome of patients who present non-emergently to an outpatient setting for a gynecological clinical examination?

P: Patients who present non-emergently to an outpatient setting for a gynecological clinical examination

I: Pelvic ultrasound

C: Clinical examination

O: Outcome 1: Reduction of morbidity

Outcome 2: Reduction of mortality

Outcome 3: Reduction in the need for standard pelvic

ultrasound

Outcome 4: Detection of gynecological diseases

Outcome 5: Reduction in the need for other imaging tests

Outcome 6: Reduction of patient anxiety

Recommendation 11

PoCUS is suggested in non-urgent outpatient settings when doubts emerge at the gynecological clinical examination.

CONDITIONAL POSITIVE RECOMMENDATION(based on high-quality guideline)

A recent guideline(SIEOG13, high-quality guideline)suggests performing PoCUS in patients who present non-emergently to an outpatient setting, when the clin-ical examination is not satisfactory. As reported in that guideline13, the available evidence did not show a signif-icant improvement of important clinical outcomes after PoCUS, but the opinion of the multidisciplinary panel was that the performance of a complementary ultrasound assessment, performed by trained specialists, may reduce the need for further imaging tests and should therefore be considered. In addition, the guideline13 also stated that complementary ultrasound may facilitate the iden-tification of patients who require hospitalization and/or emergency surgery or commencement of pharmacological treatment alternatives.

Justification for the recommendation

The working group proposed a conditional positive recommendation for this application of PoCUS. However,only 43% of the panel voted in complete agreement.During the panel discussion, concerns emerged regarding the benefit-risk balance, costs and use of resources, equity in healthcare and feasibility in every context worldwide.After discussion, taking into consideration that there are no undesirable effects for this PoCUS application, the panel decided unanimously to maintain the conditional positive recommendation.

ISUOG Guidelines

9

Recommendation 12

Question 12

Could PoCUS, performed during insertion of an intrauterine contraceptive device to confirm its location, improve the care/outcome of patients?

P: Patients who present for insertion of intrauterine contraceptive device

I: Pelvic ultrasound

C: No ultrasound

O: Outcome 1: Reduction of insertion injuries

Outcome 2: Reduction of failure of contraception

Outcome 3: Reduction of post-insertion complications

Outcome 4: Reduction of intrauterine contraceptive device misplacement

Outcome 5: Reduction in the need for standard pelvic ultrasound

Outcome 6: Reduction of patient anxiety

Recommendation 12

PoCUS may be used or not used during insertion of an intrauterine contraceptive device to confirm its location.

CONDITIONAL RECOMMENDATION FOR EITHER INTERVENTION OR COMPARISON(based on meta-analysis)

Note: There is evidence that ultrasound performed during or after insertion of an intrauterine contraceptive device(IUD)might improve patient outcomelare. However, during the panel's discussion, concerns arose regarding women's access to contraception. Therefore, the panel emphasizes that such use of PoCUS may be beneficial, but is not mandatory, and that the clinician can proceed to the insertion of an IUD even without the assistance of ultrasound.

The insertion of an intrauterine contraceptive device(IUD)is commonly associated with patient anxiety related to fear of pain. Moreover, difficulties may be encountered during insertion, and the failure rate may reach up to 14%in parous and 20% in nulliparous women. Additionally,the procedure may be particularly difficult in cases of retroverted-flexed uterus51,52. A recent meta-analysis53 showed that the use of transabdominal ultrasound guidance reduces pain during IUD insertion(mean difference,-1.91,95% CI,-3.08 to-0.73;P=0.001),reduces insertion(mean difference,-1.35,95% CI,-1.81 to-0.88;P<0.001) and is associated with fewer complication rates and misplaced devices. The use of PoCUS to confirm the location of the IUD is suggested to have a potential role in facilitating the procedure and improving patient outcomes14.

Justification for the recommendation

The working group initially proposed a conditional positive recommendation for this application of PoCUS.However, only 71% of the panel voted in complete agree-ment. During the discussion, the panel agreed that this clinical question is specific to the application of PoCUS for practitioners within the field of Ob/Gyn rather than being universally applicable across all disciplines. The

panel agreed that performing PoCUS during or after IUD insertion might improve patient outcome/care.However, concerns were raised during the discussion regarding the feasibility of this intervention in every context worldwide, which could discourage providers from offering the procedure, resulting in reduced access to contraception, and potentially leading to an increase in unintended pregnancies. Therefore, the panel agreed on a conditional recommendation for either intervention(pelvic ultrasound for IUD insertion) or comparison(no ultrasound for IUD insertion).

Recommendation 13

Question 13

Could PoCUS, performed during a dilatation and curettage procedure to treat retained products of conception, improve the care/outcome of patients?

P: Patients who present for dilatation and curettage procedure to treat retained products of conception

I: Pelvic ultrasound

C: No ultrasound

O: Outcome 1: Reduction of inadvertent injuries

Outcome 2: Reduction in treatment failure

Outcome 3: Reduction of post-procedure complications Outcome 4: Increased detection of uterine perforation

Recommendation 13

PoCUS is suggested during dilatation and curettage procedures.

CONDITIONAL POSITIVE RECOMMENDATION(based on primary randomized controlled trial)

Dilation and curettage(D&C), with or without suc-tion/vacuum aspiration, is a frequent gynecological proce-dure, and its safety is of paramount importance. However,historically, it has been carried out blindly, with an early complication rate of approximately 6%54. Such early complications include uterine perforation, exces-sive bleeding greater than 500 mL, RPOC necessitating further intervention and pelvic infection54. Data from a randomized controlled trial55 regarding surgical termina-tions of pregnancy showed that the overall complication rate was 9.8%. The procedure under ultrasound guidance had a complication rate of 3.7%(4/108) in comparison to 15.9%(17/107) for procedure performed without ultra-sound guidance(relative risk,0.23;95% CI,0.08-0.67).Intraoperative ultrasound guidance was also shown to have a statistically significant beneficial effect in reduc-ing blood loss, procedure time and convalescence time.Furthermore, PoCUS might be an alternative to facili-tate cervical dilator placement14 and ultrasound guidance could be valuable for intraoperative evaluation of difficult curetterage and evacuation procedures.

Justification for the recommendation

The working group proposed a conditional positive recommendation for this application of PoCUS. However,only 57.1% of the panel voted in complete agreement.

10

ISUOG Guidelines

Table 1 Clinical applications of point-of-care ultrasound(PoCUS) based on positive(strong/conditional) recommendations

Symptomatic patients in the first trimester of pregnancy, to assess intrauterine pregnancy and its viability

Patients with antepartum hemorrhage, to detect abnormal insertion or adhesion and aberration of the placenta

Pregnancy close to term, to confirm fetal presentation

Prior to instrumental vaginal delivery, to determine head position

Patients with uncertainty regarding fetal heart activity

Patients in late-term or post-term pregnancy, for quantitative assessment of the amniotic fluid

Patients with symptoms of preterm labor, for measurement of cervical length

Patients with postpartum hemorrhage, to identify retained products of conception

Non-pregnant patients presenting with symptoms such as abdominal pain, bleeding or abdominal distension

In non-urgent outpatient setting, when doubts emerge at the gynecological clinical examination

During dilatation and curetture procedure

$,Strong$ positive recommendation;$,conditional positive recommendation.

During the panel discussion, concerns emerged regarding the benefit-risk balance, costs and use of resources,equity in healthcare and feasibility of this intervention in every context worldwide. After discussion, taking into consideration that there are no undesirable effects for this PoCUS application, the panel decided unanimously to maintain the conditional positive recommendation.However, during the discussion, a lack of recent literature emerged on this topic, representing a research priority.

Recommendations for research

Future research is needed to investigate the impact of PoCUS during D&C procedures.

CONCLUSION

This Guideline is tailored to the specific clinical applications of PoCUS in Ob/Gyn, based on positive(strong or conditional) recommendations(Table 1).To support effective implementation and to assure applicability(Appendix S12), it is essential to establish training requisites, promote ongoing education and establish quality-control measures to guarantee operator competence in PoCUS within Ob/Gyn settings. The development of the majority of these recommendations was based on evidence from the general use of ultrasound in Ob/Gyn(Appendix S11), with the assumption that PoCUS would demonstrate comparable performance.This highlights the gaps in the literature regarding evidence-based applications of PoCUS in Ob/Gyn. This Guideline serves as a valuable aid for prioritizing research efforts to address these gaps.

GUIDELINE AUTHORS

V.De Robertis*®, Fetal Medicine Unit, Di Venere Hospital, Bari, Italy

C.M.Bilardo, Department of Obstetrics and Prena-tal Diagnosis, Amsterdam University Medical Center,Amsterdam, The Netherlands; and University Medical Centre Groningen, University of Groningen, Groningen,The Netherlands

R.Abu-Rustum®,Department of Obstetrics and Gyne-cology, University of Florida, Gainsville, FL, USA L.C.Poon®,Department of Obstetrics and Gynaecology,The Chinese University of Hong Kong, Hong Kong,China R.Kamel®, Department of Obstetrics& Gynecology,Maternal-Fetal Medicine Unit, Cairo University, Cairo,Egypt

R.Manieri Rocha®,Endometriosis and Minimally Inva-sive Surgery Division, SEMEAR Fertilidade, Human Assisted Reproduction, Ribeirão Preto, São Paulo, Brazil A.Syngelaki®,King's College Hospital, London,UK T.Stampalija®, Unit of Fetal Medicine and Prenatal Diagnosis, Institute for Maternal and Child Health,IRCCS Burlo Garofolo, Trieste, Italy; and Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy

*Correspondence.(derobertis_v@libero.it)

Collaborators(members of working groups and multidisciplinary panel)

M.Forte, Department of Family and Community Medicine, University of Toronto, Toronto, Canada; rep-resentative of the College of Family Physicians of Canada V.Noble, Department of Emergency Medicine University Hospitals Cleveland, Cleveland,OH, USA; representative of the Society of Ultrasound in Medical Education E.Dickman, Clinical Emergency Medicine Department,Maimonides Medical Center, New York City, NY, USA;

representative of The American Institute of Ultrasound in Medicine

J. Biliska, City Medical Center of Dr Jonscher, Lodz,Poland; representative of the World Patients Alliance

C.Formigoni, Executive Board GIDIF-RBM, Milan, Italy A.Ranzini, Department of Obstetrics and Gynecology,MetroHealth Medical Center, Cleveland, OH, USA

A.Ludwin, Department of Obstetrics and Gynecol-ogy, Medical University of Warsaw, Warsaw, Poland;University Centre of Mother and Child's Health, Medi-cal University of Warsaw, Warsaw, Poland; Ludwin&Ludwin Gynecology, Private Medical Center, Krakow,Poland

$$\text{ ISUOG Guidelines}$$

11

C.Landolfo, Department of Obstetrics and Gynaecol-ogy, Imperial College Healthcare NHS Trust, London,UK; Department of Metabolism, Digestion\& Repro-duction, Faculty of Medicine, Imperial College London,London, UK

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SUPPORTING INFORMATION ON THE INTERNET

The following supporting information may be found in the online version of this article:

 Appendix S1 Full details of methodology and development process of the Guideline.

Appendix S2 Details of Guideline development group.

Appendix S3 Patients, Intervention, Comparison, Outcomes(PICO) and voting.

Appendix S4 Search strategy and Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) 2020 flow diagram.

Appendix S5 Appraisal of Guidelines for Research and Evaluation II(AGREE II) evaluation of the Guideline,conducted by two independent evaluators.

Appendix S6 Evidence profiles of meta-analysis and primary studies utilized to formulate recommendations.

Appendix S7 Structure of electronic survey sent to the multidisciplinary panel (PICO in Obstetrics).

Appendix S8 Structure of electronic survey sent to the multidisciplinary panel (PICO in Gynecology).

Appendix S9 Electronic survey voting results of the multidisciplinary panel (PICO in Obstetrics).

Appendix S10 Electronic survey voting results of the multidisciplinary panel (PICO in Gynecology).

Appendix S11 Link between recommendations and supporting evidence.

Appendix S12 Applicability and implementation of the Guideline.