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T Bourne

Publications and source records attributed to T Bourne.

At least 19 recordsLinked to original sources
PubMed2007

The accuracy of first trimester ultrasound in the diagnosis of hydatidiform mole.

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.

Abortion, Spontaneous↗
PubMed2006

Prospective cross-validation of three methods of predicting failing pregnancies of unknown location.

BACKGROUND: We compared the performance of each of three tests for predicting pregnancy failure in the pregnancy of unknown (PUL) population. METHODS: In a prospective observational study, we compared the performance of three models for the prediction of pregnancy failure in women with a PUL: (i) logistic-regression model incorporating vaginal bleeding, endometrial thickness (ET), initial serum progesterone and hCG levels; (ii) serum progesterone at 0 h; and (3) the hCG ratio. RESULTS: A total of 5942 consecutive pregnant women attending the Early Pregnancy Unit were scanned and 439 (7.4%) were classified as PULs. Of these women, 420 had complete data for serum hCG at 0 and 48 h, the hCG ratio, serum progesterone at 0 h, vaginal bleeding and ET. The final outcomes were 219 (52.1%) failing PULs, 167 (39.8%) intra-uterine pregnancies and 34 (8.1%) ectopic pregnancies. For the prediction of pregnancy failure in the PUL population, the area under the receiver operating characteristic (ROC) curve (AUC) for the logistic-regression model was 0.907 (Standard error (SE) 0.015), the AUC for serum progesterone was 0.952 (SE 0.010) and the AUC for the hCG ratio was 0.980 (SE 0.004). This improved performance of the hCG ratio was significant when compared with that of initial serum progesterone (P = 0.0076) and the logistic-regression model (P < 0.0001). Using the hCG ratio cut-offs of < 0.87 and 70% for the prediction of failing PUL, sensitivities were 86.3 and 82.2% (S), 87.2% (NS) and 78.1% (S), specificities were 97.0 and 98.0% (NS), 89.6% (S) and 88.6% (S), positive-likelihood ratios were 28.91, 41.30, 8.34 and 6.82 and negative-likelihood ratios were 0.14, 0.18, 0.14 and 0.25, respectively. CONCLUSION: The hCG ratio seems to be an optimal test for the prediction of pregnancy failure in a PUL population. The hCG ratio cut-off of 0.79 is recommended on the basis of minimizing risk to those PULs discharged at 48 h. Most importantly, when the hCG ratio is below a particular cut-off, these women can be discharged at 48 h without intervention and need for further follow-up.

Adolescent↗
PubMed2006

A validation of the most commonly used protocol to predict the success of single-dose methotrexate in the treatment of ectopic pregnancy.

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.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

There is no role for uterine curettage in the contemporary diagnostic workup of women with a pregnancy of unknown location.

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 or=2000 U/l or when the initial serum hCG was <2000 U/l with a serum hCG rise of <35% over 48 h (hCG ratio<1.35); Protocol 4 advised uterine curettage with a serum hCG rise of <50% over 48 h (hCG ratio<1.50). The number of uterine curettages performed and viable IUPs that would have undergone an unplanned TOP were recorded for all protocols. RESULTS: A total of 12 572 consecutive women were scanned: 1003 (8.0%) women were classified as PULs. Training set consisted of 500 PULs: 278 (55.6%) failing PULs, 176 (35.2%) IUPs and 46 (9.2%) ectopic pregnancies (EPs). Test set consisted of 503 PULs: 255 (50.7%) failing PULs, 203 (40.4%) IUPs and 45 (9.0%) EPs. Protocol 1 when developed retrospectively on the training set would have resulted in 293 uterine curettages and no potential TOP. Protocol 1 tested prospectively on 503 PULs would have resulted in 272 uterine curettages and no potential TOP. Three established criteria were tested on the entire data set (n=1003). Protocol 2 would have resulted in 114 uterine curettages and 14 (12.3%) potential TOPs; Protocol 3 would have led to 611 uterine curettages and seven (1.2%) potential TOPs; Protocol 4 would have resulted in 617 uterine curettages and three (0.5%) potential TOPs. No harm came to the women whose EP diagnosis was delayed. CONCLUSIONS: Established criteria for the use of uterine curettage in the management of PULs, including those advocated by the American Society for Reproductive Medicine (ASRM), can theoretically result in an inadvertent TOPs. On the basis of these data, a change in contemporary clinical practice should be considered to avoid further damage to wanted pregnancies. We conclude that uterine curettage should not be used in the routine diagnostic workup of women with a PUL.

Abortion, Spontaneous↗
PubMed2006

Predicting the outcome of pregnancies of unknown location: Bayesian networks with expert prior information compared to logistic regression.

BACKGROUND: As women present at earlier gestations to early pregnancy units (EPUs), the number of women diagnosed with a pregnancy of unknown location (PUL) increases. Some of these women will have an ectopic pregnancy (EP), and it is this group in the PUL population that poses the greatest concern. The aim of this study was to develop Bayesian networks to predict EPs in the PUL population. METHODS: Data were gathered in a single EPU from all women with a PUL. This data set was divided into a model-building (599 women with 44 EPs) and a validation (257 women with 22 EPs) data set and consisted of the following variables: vaginal bleeding, fluid in the pouch of Douglas, midline echo, lower abdominal pain, age, endometrial thickness, gestation days, the ratio of HCG at 48 and 0 h, progesterone levels (0 and 48 h) and the clinical outcome of the PUL. We developed Bayesian networks with expert information using this data set to predict EPs. RESULTS: The best Bayesian network used the gestational age, HCG ratio and the progesterone level at 48 h and had an area under the receiver operator characteristic curve (AUC) of 0.88 for predicting EPs when tested prospectively. CONCLUSIONS: Discrete-valued Bayesian networks are more complex to build than, for example, logistic regression. Nevertheless, we have demonstrated that such models can be used to predict EPs in a PUL population. Prospective interventional multicentre studies are needed to validate the use of such models in clinical practice.

Adolescent↗
PubMed2006

The non-surgical management of ectopic pregnancy.

Ectopic pregnancy can now be detected at earlier gestations in asymptomatic women. As a consequence conservative treatment strategies may be more appropriate than surgical intervention. This review aims to discuss the diagnosis and the non-surgical management options for ectopic pregnancy, in particular expectant management and the use of methotrexate.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

The conservative management of cervical ectopic pregnancies.

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.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

The practical application of a mathematical model to predict the outcome of pregnancies of unknown location.

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.

Chorionic Gonadotropin↗
PubMed2006

Do early pregnancy ultrasound measurements correlate with fetal nuchal translucency at 11-14 weeks?

OBJECTIVE: To assess whether extremes in nuchal translucency (NT) thickness measurements at 11-14 weeks of gestation are preceded by departures from normal in early ultrasound biometry or embryonic heart rate in euploid fetuses. METHODS: This was a retrospective analysis of data from women with singleton pregnancies examined in early pregnancy between June 2002 and January 2003, who subsequently had a nuchal translucency (NT) scan. The early pregnancy scan was performed transvaginally, and the crown-rump length (CRL), mean gestational sac diameter (GS), mean yolk sac diameter (YS) and embryonic heart rate (HR) were measured where possible. At the second scan CRL and NT were measured. RESULTS: A total of 534 singleton pregnancies were included in the analysis. The mean maternal age was 30 (range, 14-45) years, and 59.4% of the patients were nulliparous. The mean CRL was 11.5 (range, 1.4-30.0) mm at the first scan and 62.8 (range, 42.0-88.0) mm at the second scan. GS, YS and HR measurements were obtained in 87.6%, 72.5% and 72.5% of cases, respectively. No statistically significant correlation was observed between NT and Z-scores of early pregnancy: GS (r = 0.013, P = 0.77), YS (r = 0.039, P = 0.44) or HR (r = 0.016, P = 0.76). GS, YS and HR were not significantly different in fetuses with NT measurements below the 10th percentile or above the 90th percentile (P = 0.24, 0.84 and 0.60, respectively). CONCLUSION: Ultrasound biometry and heart rate measured in early pregnancy are not related to nuchal translucency measurements at 11-14 weeks of gestation in chromosomally normal fetuses.

Adolescent↗
PubMed2006

Impact of the availability of sonography in the acute gynecology unit.

OBJECTIVE: The initial assessment of acute gynecology patients is usually based on history and clinical examination and does not involve ultrasound. The aim of this study was to investigate the impact of the availability of transvaginal sonography at the time of initial assessment of the emergency gynecology patient. METHODS: This was a prospective observational study carried out over a 5-month period in the acute gynecology unit of an inner London teaching hospital. Women were assessed in the routine manner by history-taking and clinical examination and questionnaires were completed by the doctors, including details of the intention to treat. Transvaginal ultrasound examinations were then performed and a second diagnosis and management plan were made utilizing the extra information from the scan. The plans for clinical management before and after the ultrasound examination were compared. RESULTS: We originally recruited 1000 consecutive women to the study. The mean age was 31.1 (SD, 9.81) years. Complete data were available for 920 (92%). 84 (9.1%) women did not require a scan. Of the 521 women with a positive pregnancy test, 75.6% were reassured immediately that their pregnancy was intrauterine. 143 women (27.4%) were given the diagnosis of a suspected ectopic pregnancy before sonography, compared with 29 (5.6%) after. Following the ultrasound examination there was a change in clinical management in 54.1% of the women with a positive pregnancy test and a reduction in admissions (including inpatient theater admissions) (from 40.3% to 17.1%) and outpatient follow-up examinations (from 41.1% to 35.5%). In 90 (23.8%) non-pregnant women a significant ovarian cyst (> 5 cm) was suspected clinically; 28/90 (31.1%) were confirmed on sonography. Following the ultrasound examination there was a change in clinical management for 38.1% of non-pregnant women and a reduction in admissions (from 37.1% to 19.4%) and outpatient follow-up examinations (from 25.7% to 18.1%). CONCLUSION: It appears that the availability of transvaginal sonography at the time of initial assessment of emergency gynecology patients improves diagnostic accuracy and reduces unnecessary admissions and follow-up examinations.

Adolescent↗
PubMed2006

The use of ultrasound-based 'soft markers' for the prediction of pelvic pathology in women with chronic pelvic pain--can we reduce the need for laparoscopy?

OBJECTIVE: To assess the accuracy of new transvaginal ultrasound-scan-based markers and to compare them to conventional ultrasound methods used in the detection of common pelvic pathology in women with chronic pelvic pain (CPP). DESIGN: A prospective observational study. SETTING: Teaching hospital. POPULATION: A total of 120 consecutive women with CPP undergoing transvaginal ultrasonography before either diagnostic or operative laparoscopy. METHODS: Anatomical abnormalities, e.g. endometrioma or hydrosalpinx (hard markers), were documented. The woman was then assessed for the presence or absence of 'soft markers' (reduced ovarian mobility and site-specific pelvic tenderness). MAIN OUTCOME MEASURE: Presence or absence of pelvic pathology noted during laparoscopy. RESULTS: Seventy women had pelvic pathology, of whom 51 had endometriosis alone, 7 both endometriosis and pelvic adhesions, 6 pelvic adhesions, 1 hydrosalpinx with endometriosis and 5 hydrosalpinx and pelvic adhesions. The likelihood ratio for the hard markers was infinity (specificity was 100%), for the soft makers 1.9 (95% CI 1.2-3.1) and for a 'normal' ultrasound 0.18 (0.09-0.34). The pre-test probability of pelvic disease in our population of women with CPP was 58%, and this probability of disease was raised to 100% with the presence of hard markers and to 73% with the presence of soft markers. The pre-test probability of 58% fell to 20% when ultrasound finding was found to be normal. CONCLUSION: This new approach improves the detection and exclusion of significant pathology in women with CPP and may lead to a reduction in the number of unnecessary laparoscopies carried out on women with CPP.

Adult↗
PubMed2006

Failing pregnancies of unknown location: a prospective evaluation of the human chorionic gonadotrophin ratio.

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 <0.87 predicted failing PUL, with a sensitivity of 93.1% (95% CI 85.9-97.0) and a specificity of 90.8% (95% CI 82.2-95.7) in the training set. In the test set, sensitivity was 92.7% (95% CI 85.6-96.5) and specificity was 96.7% (95% CI 90.0-99.1). The hCG ratio outperformed absolute serum hCG levels at 0 and 48 hours. CONCLUSIONS: We have defined the optimal hCG ratio for the prediction of failing PUL. Using this cutoff, clinicians can safely adopt a noninterventional approach in women with PUL.

Biomarkers↗
PubMed2005

Do levels of serum cancer antigen 125 and creatine kinase predict the outcome in pregnancies of unknown location?

BACKGROUND: The aim of this study was to evaluate the role of maternal serum cancer antigen 125 (CA 125) and creatine kinase (CK) levels in predicting the outcome of pregnancies of unknown location (PUL). METHODS: Prospective observational study. Women classified as PUL were recruited. Final outcome of each PUL was established: failing PUL, intrauterine pregnancy (IUP), ectopic pregnancy (EP) or persisting PUL. The persisting PUL group almost certainly represent ultrasonically missed EP and were included in EP group. Serum CK and CA 125 were measured at 0 and 48 h. The values at presentation and the change in levels after 2 days were used in the analysis. We incorporated the most significant of variables into a multinomial logistic regression model to predict all outcomes. The performance of this model was evaluated using receiver operating characteristic (ROC) curves. RESULTS: In all, 4698 consecutive women were scanned; 403 were classified as PUL, 27 were lost to follow-up. Of the 376 women eligible, 297 had complete data and therefore were recruited. Mean age and mean gestation were 30.0 years and 43.3 days respectively. Final outcomes: 153 failing PUL (51.5%), 116 IUP (39.1%) and 28 EP (9.4%). Mean serum CK levels at 0 and 48 h were 88.5 and 86.8 IU/l respectively. Mean serum CA 125 levels at 0 and 48 h were 43.8 and 40.1 kIU/l respectively. 81.1% of women had CK and CA 125 ratios (CK 48 h/CK 0 h, CA 125 48 h/CA125 0 h) between 0.7 and 1.3. CA 125 ratio was the only significant variable in the three outcome groups (P < 0.0001). Logistic regression analysis incorporating CA 125 ratio gave an area under ROC curve of 0.782 (SE = 0.041) for failing PUL, 0.768 (SE = 0.043) for IUP and 0.560 (SE = 0.078) for EP. This model was capable of distinguishing failing PUL from IUP, but was not able to detect EP. CONCLUSIONS: Absolute levels of serum CK and CA 125 at the defined times cannot be used to predict the outcome of PUL. Although the CA 125 ratio when incorporated into logistic regression model can distinguish failing PUL from IUP, its inability to detect the high risk PUL, i.e. the developing EP, renders it inappropriate for use in the clinical setting.

Age Factors↗
PubMed2005

A prospective evaluation of a single-visit strategy to manage pregnancies of unknown location.

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 < or =10 nmol/l or a serum HCG of < or =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.

Adolescent↗
PubMed2005

Diagnostic accuracy of varying discriminatory zones for the prediction of ectopic pregnancy in women with a pregnancy of unknown location.

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.

Biomarkers↗
PubMed2005

Do we need to follow up complete miscarriages with serum human chorionic gonadotrophin levels?

Despite a history of heavy vaginal bleeding with clots, a proportion of women diagnosed with complete miscarriage, using transvaginal sonography (TVS), have an underlying ectopic pregnancy (EP). We evaluated the need for hormonal follow up in women with history and scan findings suggestive of complete miscarriage. One hundred and fifty-two consecutive women with findings suggesting complete miscarriage at presentation based on their history and TVS were presented to the Early Pregnancy Unit. Serum human chorionic gonadotrophin (hCG) levels were taken at presentation and 48 hours. All women were followed up until hCG was <5 u/L or a pregnancy was visualised on TVS either inside or outside the uterus. Overall, 9 (5.9%) of 152 women with an apparent complete miscarriage had an underlying EP. A diagnosis of complete miscarriage based on history and scan findings alone is unreliable. These women should be managed as 'pregnancies of unknown location' with serum hCG follow up.

Abortion, Spontaneous↗
PubMed2004

The use of a new logistic regression model for predicting the outcome of pregnancies of unknown location.

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 48 h 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 48 h), M2 was based on the average progesterone level (the mean of the progesterone level at 0 and 48 h) 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.

Chorionic Gonadotropin↗