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Objective: To improve the interpretation of future studies in women who are initially diagnosed with a pregnancy of unknown location (PUL), we propose a consensus statement with definitions of population, target disease, and final outcome. Design: A review of literature and a series of collaborative international meetings were used to develop a consensus for definitions and final outcomes of women initially diagnosed with a PUL. Result(s): Global differences were noted in populations studied and in the definitions of outcomes. We propose to define initial ultrasound classification of findings into five categories: definite ectopic pregnancy (EP), probable EP, PUL, probable intrauterine pregnancy (IUP), and definite IUP. Patients with a PUL should be followed and final outcomes should be categorized as visualized EP, visualized IUP, spontaneously resolved PUL, and persisting PUL. Those with the transient condition of a persisting PUL should ultimately be classified as nonvisualized EP, treated persistent PUL, resolved persistent PUL, or histologic IUP. These specific categories can be used to characterize the natural history or location (intrauterine vs. extrauterine) of any early gestation where the initial location is unknown. Conclusion(s): Careful definition of populations and classification of outcomes should optimize objective interpretation of research, allow objective assessment of future reproductive prognosis, and hopefully lead to improved clinical care of women initially identified to have a PUL. (Fertil Steril (R) 2011; 95: 857-66. (C) 2011 by American Society for Reproductive Medicine.)

The lack of standardization in gynaecological scanning is worrying, especially with regard to the sonographic evaluation of adnexal masses. The results of ongoing trials on the use of ultrasound as a screening test for ovarian cancer are likely to be affected by this lack of standardization in terminology and classifications. The lack of high-quality gynaecological ultrasound, combined with the low prevalence of ovarian cancer, may yield to a poor performance of transvaginal ultrasound as a screening test for ovarian cancer in large trials. In order to increase the specificity of ultrasound in a screening program, thus reducing unnecessary surgeries, a uniform, reproducible and accurate method for the sonographic evaluation of ovarian masses must be implemented. This move to improve and standardize reporting in gynaecological ultrasound should negate the need to use the phrase ‘complex ovarian mass’. In this paper, we will critically evaluate current terminology, newly proposed accepted morphological classification of ovarian cysts as well as the ability for ultrasound to discriminate between benign and malignant ovarian masses.

Objectives To describe a new technique for the management of Cesarean scar ectopic pregnancy (CSEP): transrectal ultrasound (TRS)-guided surgical evacuation. Methods All women who presented at our early pregnancy units (EPU) from November 2006 to July 2008 underwent transvaginal sonography. CSEP was diagnosed if all of the following criteria were met: absence of an intrauterine pregnancy; empty endocervical canal; presence of a gestational sac implanted within the lower anterior segment of the uterine corpus, with or without evidence of myometrial thinning. Women were offered TRS-guided surgical evacuation under general anesthesia. Successful treatment was defined as complete primary evacuation of the CSEP. The need to perform additional interventions (emergency cervical cerclage, insertion of Foley's balloon catheter, blood transfusions) was recorded. Results Of 1195 consecutive women who presented at the EPUs, seven (0.59%) were diagnosed with CSEP. Three (43%) of these were viable at the time of diagnosis. Two (29%) of the seven pregnancies followed in-vitro fertilization; six (86%) women had previously had a single Cesarean section and one had had two. One of these women had a previous tubal ectopic pregnancy, and one a previous CSEP. Three (43%) of the women were asymptomatic. Five (71%) women were treated with TRS-guided surgical evacuation as the primary treatment, whilst two (29%) were given systemic methotrexate, one of whom subsequently underwent TRS-guided aspiration because of failure of conservative management. There were no major complications. Conclusions The best treatment for CSEP has yet to be established. TRS-guided surgical evacuation is a novel and potentially alternative treatment modality. However, in the absence of further studies we cannot draw any conclusions, and the management of such women should be individualized. Copyright © 2010 ISUOG. Published by John Wiley & Sons, Ltd.

To assess the impact of the introduction of an ultrasound-based model of care for women with acute gynecological complications.This was a prospective comparative study of women attending an ultrasound-based acute gynecology unit (AGU) at the Nepean Hospital during a 6-week period 4 months after the unit's inception (new model of care), and a group of women presenting at the hospital during a similar period 6 months immediately prior to the unit's inception (traditional model). In the new model of care, ultrasound was performed at the time of the initial assessment by a senior clinician. The main outcome measures were admission rates and occupied bed days.The study included 290 consecutive women with complete data, 133 before and 157 after the introduction of the AGU. Compared with the group presenting before establishment of the AGU, the group who attended the AGU had significantly lower admission rate (7% vs. 36%, P0.0001) and significantly shorter time to see a trainee gynecologist (mean, 172 vs. 205 min, P = 0.00089), time to ultrasound examination (mean, 199 vs. 533 min, P0.0001), length of stay as an outpatient (mean, 45 vs. 248 min, P0.0001), fewer occupied bed days (total, 30 vs. 85 days, P0.0001) and lower surgical intervention rates (12% vs. 29%, P = 0.00025). They also had significantly higher expectant management rate (26 vs. 8%, P = 0.00023). The extrapolated annual reduction in occupied bed days represented a total financial saving of $ 257 617 Australian dollars.In the AGU, the availability of ultrasound carried out by a senior clinician with an interest in gynecological emergencies may lead to a reduction in admissions and improved outcomes.

With increasing adoption of laparoscopic surgery in gynaecology, there has been a corresponding rise in the types and rates of complications reported. This article sets out to classify complications associated with laparoscopy according to the phases of the surgery; assess the incidence, the mechanisms, the presentations; and recommend methods for preventing and dealing with complications in laparoscopic surgery. Its aim is to promote a culture of risk management based on the development of strategies to improve patient safety and outcome.

Multiple pregnancy has increased in frequency as a result of the ageing maternal population as well as the advent and wider availability of assisted reproductive technologies. Higher-order pregnancies are associated with increased morbidity and mortality for both the foetuses and mother. The introduction of transvaginal ultrasound has made accurate diagnosis of twin pregnancy, determination of chorionicity and subsequent planning of these high-risk pregnancies a common part of obstetric care. In this article, we critically evaluate the role of transvaginal ultrasound in the diagnosis of twin pregnancies.

Ectopic pregnancy is still the number one cause of maternal deaths in early pregnancy. The diagnostic capabilities of transvaginal ultrasound to confirm an EP are well founded. In fact, ultrasound technology, particularly the introduction of high-resolution transvaginal probes, has been the driving force behind the revolutionary change towards conservative management strategies in ectopic pregnancy care. Clinically stable women, however, with a scan diagnosis of a tubal ectopic pregnancy still routinely undergo surgery or are given methotrexate (MTX) at presentation. Conservative management for ectopic pregnancy may be considered in the context of clinical stability. Reassessment at 48 h allows evaluation of the trophoblast activity or 'trophoblastic load'. Falling serum hCG levels at 48 h suggest that the ectopic trophoblast is resolving spontaneously and it may be possible to avoid methotrexate administration in this sub-group. Women with increasing serum hCG levels at 48 h, indicating the trophoblast is still active, should be targeted for methotrexate. By calculating the pre-treatment hCG ratio (hCG 48 h/hCG 0 h), it is possible to triage women with an ectopic pregnancy for conservative management. There are, however, no randomised data to support the use of MTX over expectant management. In this review, some of the current management strategies in ectopic pregnancy management will be challenged.

background: The aim was to evaluate the role of serum inhibin A and activin A in the prediction of the outcome of women with ‘pregnancies of unknown location’ (PULs). methods: Serum human chorionic gonadotrophin (hCG), progesterone, inhibin A and activin A levels were measured at 0 and 48 h. Differences in the mean levels and the change in levels over 48 h expressed as a ratio (48/0 h) were examined between the three outcome groups—failing PUL, intrauterine pregnancy (IUP) or ectopic pregnancy. Variables were incorporated into logistic regression models to predict the pregnancy outcomes, which were evaluated using receiver operator characteristic curves. results: One hundred and forty-one women were classified as PULs: 67 failing PULs (47.5%), 58 IUPs (41.1%) and 16 ectopic pregnancies (11.4%). Activin A levels were not significantly different between the three outcome groups. Inhibin A levels were significantly lower in failing PULs. The logistic regression model based on serum inhibin levels gave an area under the curve (AUC) of 0.88 for failing PUL, 0.87 for IUP and 0.60 for ectopic pregnancy. The model based on serum activin levels gave an AUC of 0.61 for failing PUL, 0.64 for IUP and 0.51 for ectopic pregnancy, and the model based on serum hCG levels gave an AUC of 0.95 for failing PUL, 0.97 for IUP and 0.67 for ectopic pregnancy. conclusions: Serum activin A levels at 0 and 48 h are not helpful in predicting the outcome of PULs. Although serum inhibin A levels may be of use in the prediction of failing PULs and IUPs in the PUL populations, they do not perform as well as serum hCG levels.

Objective Hemoperitoneum is accepted as an indication for surgery in women with tubal ectopic pregnancy. The aim of this pilot study was to evaluate the feasibility of managing such women non-surgically. Methods This was a prospective observational study. Women with tubal ectopic pregnancy and hemoperitoneum detected on transvaginal sonography (TVS) were managed as inpatients either expectantly or with methotrexate (MTX). Inclusion criteria for conservative management were: compliance, clinical stability, absence of acute abdomen, stable hemoglobin level on two measurements (0 and 12–24 h apart), serum human chorionic gonadotropin (hCG) < 5000 IU/L, absence of fetal cardiac activity on TVS and absence of significant hemoperitoneum, defined as blood above the level of the uterine fundus and/or in Morison's pouch (hepatorenal space). Subsequent management was based upon the hCG ratio at 48 h. All the women were managed as inpatients until the abdominal pain settled and the serum hCG levels were falling. Results Forty-one women with tubal ectopic pregnancy presented between November 2006 and March 2008. Eight women (20%) fulfilled the entry criteria. The median gestational age at diagnosis was 49 (interquartile range, 38–52.5) days. All women presented with lower abdominal pain/right iliac fossa or left iliac fossa pain. Hemoglobin levels ranged from 11.2 to 14.2 g/dL at presentation and from 12.0 to 14.8 g/dL after 12–24 h. 6/8 (75%) women were managed expectantly and 2/8 (25%) received MTX. All women had resolution of their ectopic pregnancy within 3 weeks with no complications. Conclusions This pilot study suggests that the finding of hemoperitoneum on ultrasound examination may not be an absolute contraindication to conservative management of tubal ectopic pregnancy. Copyright © 2009 ISUOG. Published by John Wiley & Sons, Ltd.

Objective: We developed and compared classifiers to predict the outcome of pregnancies of unknown location (PUL). This is a three-class problem, as the possible outcomes are failing PUL, intra-uterine pregnancy (IUP), or ectopic pregnancy (EP). We focused on probabilistic classification because of the importance of uncertainty information in medical decision making. Methods and materials: Nine methods were implemented, based on logistic regression (LR), multi-layer perceptrons, least squares support vector machines (LS-SVMs), and kernel logistic regression (KLR). The LR models involved manual checks for the necessity of input transformations or interaction effects. The classifiers were developed on the training set (n=508) and evaluated on the test set (n=348). We used two performance measures that only evaluate discriminatory potential, and two that investigate the exact probabilities and/or discriminatory potential. Classifier comparison was carried out using a ranking method. Results: The classifier based on a combination of binary LR models using pairwise coupling (LR-PC) ranked first or second for each performance measure. LR-PC obtained test set areas under the receiver operating characteristic curve of 0.989, 0.988, and 0.924 for the prediction of failing PULs, IUPs, and EPs, respectively. Multi-class LR, multi-class KLR, and a combination of binary Bayesian LS-SVMs with radial basis function kernel were always ranked in the top five. Models with low emphasis on nonlinearity were ranked at the bottom. Importantly, LR-PC also performed better than previously developed classifiers based on multi-class LR. Conclusions: The prediction of PULs was good, most notably for failing PULs and IUPs. Logistic regression models performed remarkably well. Multi-class KLR also performed well, whilst nonlinearity was automatically incorporated and probabilistic outputs were directly given without Bayesian analysis or a combination of binary results. The selected inputs are reasonably objective and easy to obtain in clinical practice. Taken together, this study provided useful decision support tools for implementation in clinical practice.

This review focuses on the available evidence for the use of levonorgestrel (LNG) intrauterine system (IUS) in women with chronic pelvic pain (CPP). We have searched MEDLINE, Pubmed, Embase, and the Cochrane electronic library with the keywords "chronic pelvic pain," "endometriosis," "Mirena IUS," and "levonorgestrel IUS" from 1956 through April 2008. Review articles, randomized trials, prospective cohort studies, and retrospective studies were analyzed and the available evidence included in this review. Case reports were not included in the analysis. Laparoscopic surgery was shown to be useful in clarifying the underlying cause in women with CPP, with 70% having abnormal findings at laparoscopy. Endometriosis, particularly deep infiltrating endometriosis, is found in 40% to 60% of women with dysmenorrhea. Laparoscopic excision of endometriosis was shown to be associated with improvement of symptoms in 70% to 80% of women. Up to 36% need repeated surgery during a 5-year period after the primary procedure. The absolute reduction in recurrence of dysmenorrhea in women who also had the LNG IUS inserted at the time of surgery was 35% (95% CI 9%-61%). The LNG IUS was shown also to reduce the blood flow in the uterine artery and the subendometrial spiral arteries. This may explain the reduction in primary dysmenorrhea in women who have the LNG IUS inserted. Insertion of the LNG IUS at the time of primary laparoscopic surgery in women with CPP caused by endometriosis has the potential to reduce postoperative pain scores. This medical approach is also a promising alternative to repeated laparoscopic surgery especially in those women who have continuing symptoms after laparoscopic excision of endometriosis. This nonsurgical option could potentially reduce the rate of repeated laparoscopies in women with CPP and, in turn, reduce overall intervention rates. Although growing evidence exists that the LNG IUS can be useful in this group of women, large randomized controlled studies are needed to validate its benefits in day-to-day practice.

Objective. We describe the use of a new sonographic technique for imaging of the posterior compartment of the pelvis: sonorectovaginography. Methods. Sonorectovaginography uses instillation of fluids (saline solution and ultrasound gel) in the vagina, pouch of Douglas, and rectum for the purpose of creating acoustic interfaces between the vagina, cervix, rectum, and pouch of Douglas. We performed sonorectovaginography in a woman with chronic pelvic pain during laparoscopy. Urinary catheters were introduced into the rectum and vagina. Sterile saline solution was introduced into the abdominal cavity through a laparoscopic trocar and in the rectum via a rectal catheter. The transvaginal probe was then inserted, and sterile ultrasound gel was introduced into the vagina through the vaginal catheter under sonographic guidance. Results. Sonorectovaginography has helped us create acoustic interfaces and enhanced simultaneous visualization of the vaginal walls, posterior vaginal fornix, retrocervical area, rectovaginal septum, rectal wall, and pouch of Douglas. Conclusions. Imaging of the posterior compartment of the pelvis is of paramount importance for identification of potentially difficult endometriosis cases, such as those complicated by obliteration of the pouch of Douglas or infiltration of the retrocervical area, rectovaginal septum, or vaginal or rectal wall. Sonorecto vaginography may prove helpful in evaluating this compartment of the pelvis in women with suspected deep endometriosis. Its reproducibility, tolerability, and accuracy, however, need to be validated prospectively, and normative data for the rectovaginal septum also need to be established. Key words: endometriosis; sonography; sonovaginography.

To compare the appearance and behavior of ectopic pregnancies (EPs) initially classified as pregnancies of unknown location (PULs) to those visualized on the initial transvaginal ultrasound scan (TVS).An observational study over a four-year period on women undergoing a TVS prior to diagnosis of a tubal EP. Demographic details, presenting symptoms, TVS findings, serum hCG and progesterone levels were recorded at the time of the initial TVS and at the time of diagnosis of the EP in those initially classified as a PUL.411 women with a tubal EP underwent a TVS prior to treatment. In 85.9% (353/411) the EP was visualized on the initial TVS while 14.1%(58/411) were initially classified as PULs. Those initially classified as PULs had significantly lower mean gestational age and mean initial human chorionic gonadotrophin (hCG) levels, and significantly higher mean progesterone level at presentation than those where the EP was visualized on the initial TVS. Of those with a PUL, 60.3% (35/58) had the EP subsequently visualized on TVS. At the time of diagnosis these EPs were significantly smaller (p0.0001); the appearance of the EPs, serum hCG and progesterone levels at the time of visualization on TVS were not significantly different from those visualized on the initial TVS.In women with EPs who are initially classified as PULs, failure of visualization of the EP on the initial TVS is likely to be due to the fact that they are too small and probably too early in the disease process.

BACKGROUND: To determine the effectiveness of an initial transvaginal ultrasound scan (TVS) in the detection of ectopic pregnancy in consecutive women attending an early pregnancy unit (EPU). METHODS: This was a prospective observational study. Unselected women attending a dedicated EPU underwent a TVS. Women were classified as having an intrauterine pregnancy (IUP), ectopic pregnancy or pregnancy of unknown location (PUL). Women with a PUL were followed up until the final location of the pregnancy was determined. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals (CIs) for the initial TVS in the diagnosis of ectopic pregnancy were calculated. RESULTS: During a one-year study period, 5318 consecutive women attended the EPU. Outcome data were available for 5240 (98.5%) women. Of these, the initial TVS showed an IUP in 4693 (89.6%) cases and an ectopic pregnancy in 91 (1.7%) cases. The remaining 456 (8.7%) women were classified as PUL, and of these 31 (6.8%) were subsequently found to have ectopic pregnancies. The overall sensitivity of the initial TVS in the diagnosis of ectopic pregnancy was 73.9% (95% CI: 65.1‐81.6) with a specificity of 99.9% (95% CI: 99.8‐100), a PPV of 96.7% (95% CI: 90.7‐99.3) and an NPV of 99.4% (95% CI: 99.2‐99.6). CONCLUSIONS: In unselected women attending an EPU, pregnancy location can be diagnosed accurately in over 90% of all pregnancies and in 73.9% of ectopic pregnancies with a single TVS.

The gynaecologist practising operative laparoscopy should be seen as part of a team that actively promotes patient safety, minimizing risks and optimizing outcomes. Building a culture of safety which focuses on proactive initiatives to manage risk and remove individual 'blame' should be an integral part of any operative laparoscopy unit. Thus, when adverse clinical incidents or outcomes occur, reporting of such events is encouraged and seen to be acceptable behaviour within the framework of complete patient care. By recognizing and analysing adverse outcomes, the team can develop strategies to prevent or manage a recurrence of such events. Implementing systems or solutions to prevent harm to patients is the cornerstone of any risk management programme. In this review, we discuss the development and implementation of risk management strategies in the clinical setting, and in particular how this applies to operative laparoscopy.

Objective study To estimate the value of preoperative bimanual examination of the pelvis in women undergoing total laparoscopic hysterectomy (TLH). Design Prospective observational cohort study. Setting Private hospitals and centre. Patients One hundred fourteen consecutive women undergoing TLH. Intervention All women who were scheduled to undergo TLH from May 2005 through June 2006 had a bimanual examination of the pelvis performed before surgery and the size of the uterus clinically estimated and recorded as gestational equivalents. The operating time, the estimated blood loss (EBL) during TLH, and the final weight of the uterus at histologic study were recorded. Spearman correlation coefficient analysis was used to determine whether there was a correlation between the estimated uterine size before surgery and actual uterine weight, operating time, and EBL. Measurements and main results Of the one hundred fourteen consecutive women eligible for the study, 75 had complete data and therefore were included in the final analysis. The median age was 46 years (range 34–71 years); 22.7% (17/75) had a clinically estimated normal uterus, 10.7% (8/75) had an 8–10/40 uterus, 12% (9/75) had a 10–12/40 uterus, 14.6% (11/75) had a 12–14/40 uterus, 20.0% (15/75) had a 14–16/40 uterus, 9.3% (7/75) had a 16–18/40 uterus, and 10.7% (8/75) had an 18–20/40 uterus. The median operating time was 110 minutes (range 59–240 minutes); the median EBL was 80 mL (range 20–1000 mL); and the median weight of the uterus was 181 g (range 52–1080 g). Histologic diagnoses included leiomyomata in 64.0% (48/75), adenomyosis in 44.0% (33/75), endometriosis in 22.7% (17/75), endocervical polyp in 4.0% (3/75), and normal uterus in 8.0% (6/75). The Spearman correlations between clinical size of the uterus and the weight of the uterus, the EBL, and the operating time were 0.81, 0.33, and 0.29, respectively; that is, the 2 variables tended to increase together. These correlations were all significant (p Conclusions This study showed significant correlation between clinical estimate of uterine size and histologic weight of the uterus, operating time, and EBL in women undergoing laparoscopic hysterectomy. These findings are of great value in preoperative counseling in relation to the risk of bleeding and the potential need for blood transfusion, and in operating room planning.

To develop a strategy to rationalize the follow-up of pregnancies of unknown location (PULs) based on the predicted outcome using a mathematical model.Prospective interventional study. Women classified with a PUL had serum hCG levels taken at 0 and 48 h. A logistic regression model was used to predict PUL outcome at 48 h. Women were managed according to the model's prediction. If the model predicted an intrauterine pregnancy (IUP) or ectopic pregnancy (EP), women underwent a repeat scan on day 7; if the model predicted a failing PUL and the hCG ratio was also0.87, these women were discharged; if the model predicted a failing PUL and the hCG ratio wasor =0.87, serum hCG was repeated on day 7.Three hundred and sixty-three PULs were included; the final clinical outcomes were 22 (63.1%) failing PULs, 111 (30.6%) IUPs and 23 (6.3%) EPs. 88.7% (322/363) had the location of their pregnancy confirmed in the time period according to the study protocol, i.e. day 2 for failing PULs, day 7 for IUPs and EPs. By day 7, 97.5% (354/363) had been given a diagnosis and could be eliminated from any further follow-up. Only one woman (0.3%) underwent surgical intervention for the diagnosis of her pregnancy location-a diagnostic laparoscopy and surgical evacuation.The logistic regression model developed could be used as a basis on which to rationalize the management of PULs as it can successfully minimize their follow-up by reducing the number of visits, scans and blood tests, as well as intervention rates.

Introduction: Bartholin's cysts/abscess affects 2% of women. Conventional treatment is marsupialisation under general anaesthetic. We evaluated a conservative approach in a non-randomised prospective interventional study over 12 months. Method: Women with a Bartholin's abscess were counselled and those who opted for the Word catheter (WC) had it inserted under local anaesthetic (follow up at one week and four weeks, when catheter was removed). Women recorded pain scores and completed a qualitative questionnaire and had telephone follow up at six months. Outcome measures were abscess resolution and acceptability of treatment. Results: Fifty-eight women attended with a Bartholin's abscess requiring drainage. Twenty-three of 58 (40%) elected for marsupialisation. Thirty-five of 58 (60%) women had a WC inserted. Twenty-seven of 35 (77%) women retained their catheter for four weeks (three catheters fell out within 24 h of insertion, three catheters fell out within one week, one fell out after 11 days and there was one failed insertion). One woman had a recurrence six months after treatment. Abscess resolution occurred in 34 of 35 (97%). No woman reported significant discomfort at one week. Twenty-four of 27 women (89%) said that if they suffered a recurrence, they would have another WC inserted. Three of 27 (11%) women had intercourse within the second week of catheter insertion and reported that it was not uncomfortable. Fourteen women who had marsupialisation were traced and none had suffered a recurrence six months after treatment. Conclusions: The WC is a safe and effective treatment for a Bartholin's abscess. It may be considered as an alternative to marsupialisation.

The diagnosis of tubal ectopic pregnancy should be based upon the positive visualization of an adnexal mass using transvaginal ultrasound rather than the absence of an intrauterine gestational sac. Ultrasound diagnosis earlier in the natural history of the condition has meant that more conservative treatment options can be considered and implemented in clinically stable women. Although laparoscopy traditionally is accepted as the gold standard in the diagnosis of tubal ectopic pregnancy, there is substantial evidence that transvaginal ultrasound is the diagnostic tool of choice in modern practice. In expert hands, this single noninvasive and reproducible diagnostic test correlates well with the presence of ectopic pregnancy at the time of surgery. This article discusses the use of ultrasound as a single stand-alone test in the diagnosis of tubal ectopic pregnancy.

Objective Previous studies have examined ultrasound findings in histopathologically confirmed cases of hydatidiform mole. The aim of this study was to assess the first-trimester ultrasonographic findings in all women suspected of having hydatidiform mole on ultrasound and those subsequently diagnosed with hydatidiform mole after histological examination of removed products of conception after surgical evacuation of the uterus. The aim was to obtain a true sensitivity and positive predictive value for ultrasound in the diagnosis of hydatidiform mole. Methods A retrospective analysis was performed of all cases of sonographically suspected hydatidiform mole and histologically proven hydatidiform mole presenting to the Early Pregnancy Unit of an inner city hospital over a 4-year period. The sensitivity and positive predictive value (PPV) of ultrasound in the detection of histologically proven hydatidiform mole was calculated. Results The study group consisted of 90 women; 56 were suspected of having hydatidiform mole on ultrasound, and of these 27 (48%) had hydatidiform mole confirmed after histopathological examination of the products of conception, while no changes suggestive of hydatidiform mole were present in the other 29 cases. Overall, 61 women had hydatidiform mole confirmed on histology—41 (67%) partial hydatidiform moles (PHM) and 20 (33%) complete hydatidiform moles (CHM). The ultrasound findings in the 34 cases not suspected of hydatidiform mole were an empty sac in 8/34 (24%) women and a delayed miscarriage in the other 26/34 (76%). The overall sensitivity and positive predictive value for the ultrasound diagnosis of hydatidiform mole was 44% and 48%, respectively. For PHMs the respective values were 20% and 22% and for CHMs they were 95% and 40%. Conclusion Ultrasonography is more reliable for diagnosing CHMs than for PHMs. Overall, the sensitivity of ultrasound for accurately predicting hydatidiform mole is 44%, and one in two women with an abnormal scan will have the disease confirmed on histology. Copyright © 2007 ISUOG. Published by John Wiley & Sons, Ltd.

In recent years, knowledge has evolved regarding the role of transvaginal sonography in the assessment of the pouch of Douglas status and the preoperative prediction of extraovarian endometriosis in specific locations. Despite these advances in transvaginal sonography, the challenge of developing a comprehensive, cost-effective, and reproducible preoperative classification system for endometriosis remains. Critical to this classification system should be a sonographically based evaluation protocol that is systematic, evidence based, and reproducible with clearly defined end points. To date, no structured evaluation protocol exists for the assessment of the pelvis in women with suspected endometriosis. In this article, we propose a domain-based evaluation protocol for the assessment of women with suspected endometriosis using transvaginal sonography.

Objectives To generate and evaluate a new prediction model for miscarriage in women who present with a viable intrauterine pregnancy (IUP) at the primary early pregnancy scan and to compare this new model to a previously published model. Materials and Methods Data were collected prospectively from women presenting to the early pregnancy unit with a viable IUP between November 2006 and January 2013. More than 30 historical, clinical and ultrasonographic variables were recorded on a standardised datasheet at the first visit. Women were followed until the final outcome was known at the end of the first trimester: viable IUP or miscarriage. A new multinomial logistic regression model was developed retrospectively on training cases and tested prospectively on test cases. The performance of the new prediction model was evaluated using receiver operating characteristic (ROC) curves and compared to a previously published model. After removing cases with missing values for the model of Oates, the area under the ROC curve (AUC) was also calculated for the new model and the Oates model. Results A total of 1115 consecutive first-trimester women presented to the early pregnancy unit. Eight hundred and sixty-two women with a viable IUP at the first scan whose outcome was known at the end of the first trimester were included in the final analysis. Five hundred and sixty-six women were included in the training set and 296 in the test set. 92.1% were viable and 7.9% had miscarried at the end of the first trimester. The most significant independent prognostic variables for the logistic regression model were as follows: maternal age, embryonic heart rate (EHR), logarithm [gestational sac (GS) volume/crown-rump length (CRL)], CRL and the presence or absence of clots per vagina (PV) at presentation. The performance of the new model compared with the Oates model gave an AUC of 0.870 vs 0.847 for the training set and 0.783 vs 0.744 for the test set. After removing cases with missing values for the model of Oates 2013, the performance of the new model compared to the Oates model gave an AUC of 0.887 vs 0.861 for the training set and 0.816 vs 0.734 for the test set (P-value

Ectopic pregnancy (EP) is one of the most common gynecological emergencies and needs to be considered in any women of childbearing age who presents with abdominal pain and/or vaginal bleeding, a positive pregnancy test, and a change in bowel habit. Although early diagnosis and management (expectant/medical/surgical) have excellent outcomes, failure to recognize the symptoms of an EP can result in increased morbidity and even mortality. As stated previously, only 50 % of women who present with an EP have identifiable risk factors. This can make early diagnosis difficult unless a high index of suspicion and vigilance is maintained by clinicians, with careful attempt to identify risk factors for EP in this specific group of women.

BACKGROUND: Currently, the likely success of single-dose methotrexate (MTX) (50 mg/m 2 ) for the treatment of ectopic pregnancy is indicated by a >15% decrease in hCG from days 4-7 after administration. The aim of this study was to assess this protocol and to develop new rules that could be used to predict the outcome at an earlier stage. METHODS: Data were collected prospectively. Women receiving MTX for an ectopic pregnancy had serum hCG and progesterone levels checked on days 1, 3, 4, 5 and 7. Other factors including age, gestational age, previous obstetric history and ultrasound findings were recorded. The women were followed up until the outcome of medical management was known. Univariate analysis was performed to determine the benefit of the '15% day 4-7 rule', as well as to develop new rules, which potentially could be used to predict the likelihood of success before 7 days. Historical and ultrasound variables were also analysed to identify the significant variables associated with successful conservative management. RESULTS: The success rate of single-dose MTX was 68.1% (47/69). A second dose was required in 18.8% (13/69) of cases, and it was successful in 84.6% (11/13). The 15% day 4-7 rule correctly predicted the outcome in 90.3% of cases [sensitivity 93.0%, specificity 84.2%, positive predictive value (PPV) 93.0% and negative predictive value (NPV) 84.2%, Fisher exact test P-value < 0.0001]. New rules were developed based on the percentage change day 4-5 and logistic regression models incorporating day 5 hCG levels and ultrasound findings. These new rules did not outperform the current 15% day 4-7 rule. CONCLUSIONS: We have confirmed that a 15% decrease in serum hCG between day 4 and day 7 is a very good indicator of the likely success of MTX. The development of new rules did not significantly improve our ability to predict a successful outcome at an earlier stage.

BACKGROUND: The aim of this study was to generate and evaluate a new protocol that defined non-viability in the pregnancy of unknown location (PUL) population and therefore ensured no viable intra-uterine pregnancy (IUP) would be interrupted if uterine curettage was performed. A secondary aim was to evaluate published biochemical criteria that define non-viability in a PUL population to establish if these criteria could result in inadvertent termination of pregnancy (TOP) if uterine curettage was performed. METHODS: All clinically stable women classified as having a PUL were included in this study. Protocol 1 was developed retrospectively based on data from 500 consecutive PULs. Using this protocol, no cases of viable IUPs would undergo uterine curettage and the potential for TOP was eliminated. This protocol was then validated prospectively on the data from a further 503 consecutive PULs. Results were then compared with three established criteria (Protocols 2–4) for the use of uterine curettage as a diagnostic tool to classify the location of PULs. Protocol 2 defined non-viability when the hCG ratio (hCG at 48 h/hCG at 0 h) was £1.66; Protocol 3 advised uterine curettage at serum hCG levels of ³2000 U/l or when the initial serum hCG was

Objective To assess the performance of the human chorionic gonadotrophin (hCG) ratio (hCG 48 hours/hCG 0 hour) to predict spontaneous resolution of pregnancies of unknown location (PUL). Design Prospective cohort study. Setting Teaching Hospital Early Pregnancy Unit. Population Women classified as having a PUL. Methods The optimal cutoff value for hCG ratio (serum hCG at 48 hours/serum hCG at 0 hours) was calculated from data on 189 consecutive PULs (the ‘training set’). This cutoff was tested prospectively on a further 200 consecutive PULs (the ‘test set’). The hCG ratio was also compared to absolute levels of serum hCG at 0 and 48 hour for the prediction of failing PULs. Main outcome measures hCG ratio in spontaneously resolving (‘failing’) PUL compared with those requiring intervention. Optimum cutoff determined and tested to predict spontaneously resolving PUL. Comparison of hCG ratio with absolute levels of serum hCG. Results A total of 3996 consecutive women were scanned, of which 438 (11.0%) were classified as PULs. Complete data were available for 389 women: 189 in the training set and 200 in the test set. In the training set, there were 102 (54%) failing PUL, while 109 (55%) in the test set. hCG ratio of

Objective A logistic regression model has been developed previously to predict which pregnancies of unknown location (PULs) become ectopics. This model was based on the human chorionic gonadotropin (hCG) ratio (hCG 48 h/hCG 0 h). The aim of this study was to evaluate the model in an early pregnancy clinical setting. Methods This was a prospective non-interventional observational study. Women classified as having a PUL had serum hCG and progesterone levels taken at presentation and 48 h later. At 48 h, nurse practitioners in the early pregnancy unit gave their subjective assessment of the likely pregnancy outcome based upon existing strategies to predict the outcome of PULs and their own previous experience. This was used as the basis for the clinical management of the women. The hormonal data were then entered into the model, which was available on the clinic computer in the form of a Microsoft Excel package, and the predicted outcome according to this model was recorded for each case. The model was weighted in favor of detecting an ectopic pregnancy at the expense of failing PULs and intrauterine pregnancies. All women were followed up until the final true diagnosis was established: a failing PUL, an intrauterine pregnancy or an ectopic pregnancy. The predicted outcome according to the model was compared with that of the subjective assessment of the expert operator and the true outcome after follow-up. Results Data were obtained from 357 women classified as having PULs. The final clinical outcomes were: 162 (45.4%) failing PULs, 166 (46.5%) intrauterine pregnancies and 29 (8.1%) ectopic pregnancies. Subjective assessment utilizing current strategies gave sensitivities of 79.3%, 92.8% and 87.0% for the detection of ectopic pregnancy, intrauterine pregnancy and failing PUL, respectively. The model detected ectopic pregnancy, intrauterine pregnancy and failing PUL with sensitivities of 82.8%, 86.8% and 73.5%, respectively. There were no adverse outcomes. Conclusion This logistic regression model, based on the hCG ratio, can be used to predict the outcome of PULs, especially the ectopic pregnancies, with a high degree of certainty. It compares favorably with subjective assessment by experienced operators using current strategies to predict the outcome of PULs. The model can be used by those with limited knowledge or understanding of the behavior of serum biochemistry in the first trimester and in turn aid in the classification of PULs into those at low and those at high risk of ectopic pregnancy at 48 h. Copyright © 2006 ISUOG. Published by John Wiley & Sons, Ltd.

Objective To evaluate the role of conservative management in the treatment of cervical ectopic pregnancies. Methods This was a retrospective analysis of all cervical ectopic pregnancies diagnosed in women attending our early pregnancy unit between April 1997 and September 2004 inclusive. The diagnosis of cervical ectopic pregnancy was made using transvaginal ultrasound. Clinical and demographic data were recorded in all cases. Serum human chorionic gonadotropin levels were measured at presentation and monitored subsequently to determine the rate of successful resolution. Conservative management was in the form of medical or expectant management. Medical management involved administration of systemic or intra-amniotic methotrexate, with or without intra-amniotic potassium chloride. Systemic methotrexate was either a single dose of 50 mg/m2 or an alternate-day regimen of methotrexate at 1 mg/kg (days 1,3,5) with folinic acid rescue (days 2,4,6). If intra-amniotic treatment was required, this was either 50 mg methotrexate or 5 mmol/L potassium chloride. Results Seven cervical ectopic pregnancies were diagnosed during the study period. Three cases were managed successfully with a single dose of methotrexate. One case was managed successfully using a multiple-dose methotrexate regimen. Another case failed medical management with both the single- and multiple-dose regimens but was successfully treated after potassium chloride was given intra-amniotically under ultrasound guidance. One case was successfully treated with intra-amniotic methotrexate and another was managed expectantly. There was no associated morbidity or mortality during the study period. We also performed a review of the current literature. Conclusion The conservative management of cervical ectopic pregnancy is effective and safe. Copyright © 2006 ISUOG. Published by John Wiley & Sons, Ltd.

The primary aim was to assess whether ectopic pregnancies (EPs) visualised on primary scan behave differently to EPs initially characterised as pregnancies of unknown location (PUL). The secondary aim was to assess whether the EP group is more likely to have surgical management compared to the PUL ectopic pregnancy group.Prospective observational study. Consecutive first trimester women presenting from November 2006 to March 2012 underwent transvaginal ultrasound (TVS). Women diagnosed with an EP on TVS were divided into two groups: visualised EPs noted on the first TVS, and PULs which subsequently developed into EPs. Twenty-five historical, clinical, biochemical and ultrasonographic variables were collected. Different management strategies (expectant, medical, surgical) once an EP was confirmed on TVS were recorded. Univariate analysis was performed to compare differences between the two groups as well as rates for the three final management strategies.A total of 3341 consecutive women underwent TVS. On initial scan, 86.2% were classified as intrauterine pregnancy, 8.8% as PUL and 5.0% as EP (145 tubal/23 nontubal EPs). There were 194 tubal EPs in final analysis: 49 of 194 (25.3%) initially classified as PUL and 145 of 194 (74.7%) diagnosed as EP at primary TVS. When comparing the EP to the PUL EP group, the pain scores were 3.34 versus 1.91 (P-value0.001), the mean sac diameters were 35.2 versus 18.5 mm (P-value = 0.0327), and the volume of the EP masses were 8.21E+04 versus 1.40E+04 (P-value = 0.0341). Cumulative surgical intervention rate was significantly higher in EP compared to PUL EP group (P-value = 0.036).EPs seen at the first ultrasound scan appear to be more symptomatic, larger in diameter and volume compared to EPs which started as PULs. Cumulative surgical intervention rate was noted to be higher in this group with EP seen on ultrasound at the outset.

Purpose of review This review discusses the current diagnostic and therapeutic role of ultrasound in the management of pelvic pain. Recent findings Recent advances in ultrasound technology and expertise have facilitated the accurate diagnosis of common gynaecological and nongynaecological pathologies. Peritoneal and deep infiltrating endometriosis can now be diagnosed using hard and soft ultrasound-based markers. The combination of ultrasound-guided aspiration and instillation of a sclerosant is an alternative to surgery in the management of adnexal masses. Summary Experience is a key factor in the ability of transvaginal ultrasound to characterize common gynaecological disorders with accuracy. Therapeutic ultrasound provides an alternative to surgery.

Objectives Various serum human chorionic gonadotropin (hCG) discriminatory zones are currently used for evaluating the likelihood of an ectopic pregnancy in women classified as having a pregnancy of unknown location (PUL) following a transvaginal ultrasound examination. We evaluated the diagnostic accuracy of discriminatory zones for serum hCG levels of > 1000 IU/L, 1500 IU/L and 2000 IU/L for the detection of ectopic pregnancy in such women. Methods This was a prospective observational study of women who were assessed in a specialized transvaginal scanning unit. All women with a PUL had serum hCG measured at presentation. Expectant management of PULs was adopted. These women were followed up with transvaginal ultrasound, monitoring of serum hormone levels and laparoscopy until a final diagnosis was established: a failing PUL, an intrauterine pregnancy (IUP), an ectopic pregnancy or a persisting PUL. The persisting PULs probably represented ectopic pregnancies which had been missed on ultrasound and these were incorporated into the ectopic pregnancy group. Three different discriminatory zones (1000 IU/L, 1500 IU/L and 2000 IU/L) were evaluated for predicting ectopic pregnancy in this PUL population. Results A total of 5544 consecutive women presented to the early pregnancy unit between 25 June 2001 and 14 April 2003. Of these, 569 (10.3%) women were classified as having a PUL, 42 of which were lost to follow up. Of the 527 (9.5%) cases with PUL analyzed, there were 300 (56.9%) failing PULs, 181 (34.3%) IUPs and 46 (8.7%) ectopic pregnancies. Overall, 74.6% were symptomatic and 25.4% were asymptomatic (P = 8.825E–07). The sensitivity and specificity of an hCG level of > 1000 IU/L to detect ectopic pregnancy were 21.7% (10/46) and 87.3% (420/481), respectively; for an hCG level of > 1500 IU/L these values were 15.2% (7/46) and 93.4% (449/481), respectively, and for an hCG level of > 2000 IU/L they were 10.9% (5/46) and 95.2% (458/481), respectively. Conclusions Varying the discriminatory zone does not significantly improve the detection of ectopic pregnancy in a PUL population. A single measurement of serum hCG is not only potentially falsely reassuring but also unhelpful in excluding the presence of an ectopic pregnancy. Copyright © 2005 ISUOG. Published by John Wiley & Sons, Ltd.

BACKGROUND: The aim was to assess whether women with a pregnancy of unknown location (PUL) can be safely excluded from potentially unnecessary multiple clinic visits. METHODS: A single-visit protocol was developed based upon data from 200 consecutive PULs. PULs were divided into groups according to the probable risk of ectopic pregnancy. Those PULs with an initial serum progesterone #10 nmol/l or a serum HCG of #25 U/l were deemed to be at low risk and classified as resolving or failing PULs. Those PULs with an initial serum progesterone of > 50 nmol/l, regardless of serum HCG, were thought to be a probable intra-uterine pregnancy (IUP) and were also classified as being low risk. Those PULs with an initial serum progesterone of 10 ‐50 nmol/l and a serum HCG of >25 U/l were classified as being at high risk. This protocol was then tested prospectively on 318 consecutive PULs. Management was based solely on the basis of an initial transvaginal ultrasound scan (TVS) and a single measurement of HCG and progesterone taken at the time of initial consultation. RESULTS: A total of 5544 consecutive women were scanned, of which 560 (10.1%) women were classified as PULs. Forty-two were lost to follow-up and therefore 518 (9.34%) were analysed. In the training set of 200 PULs, there were 111 (55.5%) failing PULs, 67 (33.5%) IUPs and 22 (11%) ectopic pregnancies. In the test set of 318, there were 189 (59.4%) failing PULs, 114 (35.8%) IUPs and 15 (4.7%) ectopic pregnancies. For the training group, the sensitivity and specificity of a single visit to detect low-risk PULs were 77 and 82%, respectively. The positive (PPV) and negative predictive values (NPV) were 97 and 31%, respectively. For the test group of 318 PULs, the sensitivity and specificity were 84 and 33%, respectively. The PPV and NPV were 96 and 9.4%, respectively. CONCLUSIONS: A single-visit strategy based on commonly used criteria eliminates 84% of non-ectopic pregnancies correctly from the system. However, as 67% of ectopic pregnancies are discharged without adequate follow-up, a single-visit strategy should not be used as an alternative to the current multi-visit strategy used in most units.

Over the past three decades, the diagno-sis and management of ectopic preg-nancy (EP) has witnessed significantchange. Key developments have been agreater awareness of EPs, tertiary hospi-tal early pregnancy units (EPUs), intro-duction of high resolution transvaginalultrasound (TVS) probes and availabilityof accurate and rapid serum human cho-rionic gonadotrophin (hCG) assays.However, EP is still a leading cause ofmaternal mortality and significant mor-bidity worldwide. On the basis of themost recent figures from the UK, EPaccounts for 54% of all first trimestermaternal deaths

BACKGROUND: The aim of this study was to generate and evaluate new logistic regression models from simple demographic and hormonal data to predict the outcome of pregnancies of unknown location (PULs). METHODS: Data were collected prospectively from 185 consecutive women classified as having a PUL by transvaginal scan; blood was taken at presentation and 48h later to measure serum progesterone and HCG. These women were followed-up until the outcome was established: an intrauterine pregnancy (IUP), an ectopic pregnancy (EP) or a failing PUL. Three multi-categorical logistic regression models were tested. M1 was based on the HCG ratio (rate of change in HCG over 48h), M2 was based on the average progesterone level (the mean of the progesterone level at 0 and 48h) and M3 was based on the patient’s age. RESULTS: A total of 102 failing PULs, 63 IUPs and 20 EPs were used in the training set to develop the new models. The best of these models, M3, gave a retrospective area under the receiver operating characteristic (ROC) curve of 0.984 for failing PUL, 0.995 for IUP and 0.920 for EP. All three models were tested prospectively on the test set of 196 cases. M1 outperformed M2 and M3 when tested prospectively. The area under the ROC curve (AUC) was 0.975 for failing PUL, 0.966 for IUP and 0.885 for EP. M1, for the detection of EP, had a sensitivity of 91.7%, a specificity of 84.2%, a positive likelihood ratio of 5.8, a positive predictive value of 27.5% and a negative predictive value of 99.4%. CONCLUSIONS: The logistic regression model M1, can predict which PULs will become failing PULs, IUPs and, most importantly, EPs based on the patient’s HCG ratio alone.

Objective To assess the prevalence and natural history of ovarian pathology in pregnancy. Methods Three thousand consecutive pregnant women presenting before 14 weeks' gestation at the early pregnancy unit at St George's Hospital, London, underwent ultrasound examination during which both ovaries were visualized. Women found to have a simple ovarian cyst with a minimum diameter ≥25 mm or a complex ovarian cyst of any size were included in the study. They were followed up with ultrasound scans every 4–6 weeks until either resolution of the ovarian cyst occurred, intervention was required or the pregnancy was concluded. If the cyst persisted at 20 weeks' gestation, these women were rescanned 6 weeks after conclusion of the pregnancy. Women were managed expectantly throughout their pregnancy. Results One hundred and sixty one women with a total of 166 cysts were included for analysis. At presentation, 43.7% of the women were asymptomatic and 56.3% had pain and/or vaginal bleeding. The mean gestational age at presentation was 53 (range, 28–98) days, the mean maternal age was 30 (range, 17–42) years, and the mean ovarian cyst diameter was 48 (range, 12–115) mm. The first-trimester pregnancy diagnoses were 106 intrauterine pregnancies, 40 miscarriages, five ectopic pregnancies, three pregnancies of unknown location and seven terminations of pregnancy. The sonographic features of the ovarian cysts included: 117 simple and anechoic, 21 hemorrhagic, 16 with mixed echogenicity, seven with a ground-glass appearance, three solid/cystic with papillary projections and two with low-level echoes. One hundred and nineteen (71.7%) of the cysts resolved spontaneously and were presumed to be physiological, 40 (24.1%) persisted and seven (4.2%) required intervention, four of these as an emergency because of pain. There was one case of borderline malignancy and no cases of malignancy. Five (3.0%) of the cysts underwent torsion. Only 0.13% (4/3000) of all women who initially presented to our unit required acute intervention during their pregnancy. Conclusions The majority of cysts detected in early pregnancy are physiological and resolve. Very few persist and intervention during the pregnancy is rarely indicated. The expectant management of ovarian cysts detected in the first trimester is safe and should be encouraged. Examining the ovaries in the first trimester is of limited value. Copyright © 2004 ISUOG. Published by John Wiley & Sons, Ltd.

Abnormal uterine bleeding is a common symptom. Modern management should be based on a “one-stop” approach to which transvaginal ultrasound is ideally suited as a primary diagnostic tool. In premenopausal women focal pathology, such as fibroids and polyps, as well as extra uterine pathology, can be accurately diagnosed. In postmenopausal women endometrial cancer can be excluded. In the majority of women diagnostic hysteroscopy can thus be avoided, and patients with focal pathology detected with transvaginal ultrasound can be triaged for operative intervention. Outpatient endometrial biopsy should still be used to exclude endometrial pathology. This one-stop ultrasound-based clinical approach provides a rapid, accurate diagnosis, with the minimum of investigations and invasive procedures. In this way multiple outpatient visits and unnecessary inpatient admissions can be avoided.