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Papers by Mark Cordina

Research paper thumbnail of The accuracy of antenatal ultrasound screening in Malta: a population-based study

Journal of the Turkish-German Gynecological Association, Dec 1, 2022

Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detectio... more Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detection rates within the private and public sectors, and with the rest of Europe. To assess local trends in accuracy for each organ system. Material and Methods: Ethics approval was obtained to gather routinely collected data from the national congenital anomalies registry between 2016 and 2018. This was analysed to determine local antenatal ultrasound accuracy rates and trends. Electronic medical appointment record data was also used to indirectly determine whether a significant difference existed in the detection of antenatal anomalies in mothers scanned privately and those scanned within the public sector. χ 2-for-trend was used to analyse changes in the accuracy rates. European Surveillance of Congenital Anomalies (EUROCAT) data was used to compare scanning accuracy in Malta and other EUROCAT centres. Results: The local rate of undetected congenital anomalies was 62.0% for public scans and 83.9% for private scans. Local trends over the threeyear period showed an improvement in accuracy rates in detecting isolated syndromes (p=0.05), anomalies of the renal system (p=0.02) and craniofacial anomalies (p=0.05). Malta's overall performance was similar to other EUROCAT centres. Conclusion: Scans carried out within the public sector are more accurate than private scans, and Malta's overall performance was similar to other EUROCAT centres.

Research paper thumbnail of Is There a Role for Hyperglycosylated hCG in the Diagnosis of Ectopic Pregnancy in Women with a Pregnancy of Unknown Location?

PubMed, 2017

OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identi... more OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identifying ectopic pregnancies in pregnancies of unknown location (PULs) on ultrasound scan. STUDY DESIGN: This was a prospective observational study. An additional blood sample was taken from women whose initial transvaginal ultrasound scan showed none of the following: intact intrauterine pregnancy, retained placental tissue, or ectopic pregnancy. Parallel sandwich ELISAs were performed using sheep monoclonal antibodies to the 12F6 epitope for detection of total hCG and to the 4D8 epitope for hCG-H detection, and an automated immunoassay technique was used for progesterone and serum β-hCG measurements. Patients were managed accord-ing to our standard clinical protocol. RESULTS: hCG-H was significantly higher in ectopic pregnancies (85.6 ng/mL) than in viable intrauterine pregnancies (26.8 ng/mL) and spontaneously resolving pregnancies (23.2 ng/mL). The ability to distinguish ectopic pregnancies from nonectopic pregnancies, expressed as area under the curve, was 0.816 for hCG-H and 0.824 for total hCG. CONCLUSION: Women with an underlying ectopic pregnancy tended to have higher hCGs, whichever assay was used. However, the current study does not support a role for a single measurement of hCG-H in the diagnosis of ectopic pregnancy within the PUL population.

Research paper thumbnail of Anomaly Scans – a 1 year plus review at Mater Dei Hospital Obstetric Unit

European Journal of Obstetrics & Gynecology and Reproductive Biology, 2016

The diagnosis of gestational diabetes mellitus (GDM) in Malta is based on the American Diabetes A... more The diagnosis of gestational diabetes mellitus (GDM) in Malta is based on the American Diabetes Association (ADA) guidelines. International Association of Diabetes and Pregnancy Study Group (IADPSG) guidelines have more stringent criteria for diagnosis. The aim of this audit was to assess adherence of current practice to ADA guidelines. Patients whose random blood glucose (RBG) levels fell under IADPSG criteria were also reviewed to identify patients diagnosed with GDM otherwise not identified on the basis of ADA criteria. Methods: The medical data of patients attending for a booking visit in April and May 2014 at Mater Dei Hospital was reviewed. Blood results were obtained from iSoft clinical manager, focusing on the booking RBG, follow-up fasting blood glucose (FBG) and oral glucose tolerance test (oGTT). Results: Out of a total of 819 cases, 13 patients had an RBG above the upper limit set by ADA. Out of these, 3 patients were followed up with an FBG and 4 with an oGTT and 3 patients had no follow-up blood glucose testing done. A follow-up postpartum oGTT was done for only one patient. 355 patients were identified to have an RBG level above the upper limit of the IADPSG guidelines; 35 patients had an oGTT, out of which 13 patients would be classified as having GDM. Conclusion: Lack of adherence to ADA guidelines for GDM screening was noted. Moreover, GDM was diagnosed in patients who did not fall under ADA criteria for screening, questioning their suitability for the Maltese population.

Research paper thumbnail of OC05.07: Introduction of a modified protocol for the management of patients with pregnancy of unknown location

Ultrasound in Obstetrics and Gynecology, 2009

Introduction: ACR has developed a BI-RADS lexicon of the breast sonography in order to standardiz... more Introduction: ACR has developed a BI-RADS lexicon of the breast sonography in order to standardize the characterization of sonographic breast lesions. Purpose: To analyze the accuracy of the categorization of sono-mammographic results according to the BI-RADS use criteria and breast cancer. Methods: In the period of 2002-2008, in our policlinic sonomammography was performed on 2719 patients. Sonographic findings are categorized according to respective criteria of BI-RADS sono-mammography. Every change has been described by use of these features and is classified in categories from 1 to 5, according to BI-RADS for sono-mammography. Categorization and biopsy results have been compared. Results: In 32 (1.2%) patients, sono-mammography could not be assessed due to the extreme tissue density. Categorization 1normal was found in 758 (27.9%) patients. Simple cysts classified as category 2 are found in 988 (36.3%) women. In 567 (20.9%) patients suspicious benign solid masses have been found categorized as category 3. Local suspicious processes for the malignant process categorized as category 4 are found in 234 (8.6%) women and local processes suggest high malignity possibility categorized as category 5 is found in 140 (5.1%) patients. Histological results were possible in 37 (6.5%) masses that are classified by BI-RADS as category 3, in 102 (43.5%) of the category 4, and 129 (92.1%) of the category 5. The level of malignant findings was: 2.7% (n=1) in category 3, 17.6% (n=18) in category 4 and 92.2% (n=119) in category 5. For the category 4, OR=7.7, 95% CI 0.991-60.02. For the category 5 OR=428.4, 95% CI 53.0-3462.5. Conclusion: The assessment of findings during malignity sonomammography based on criteria used by BI-RADS of the breast sonography, has high level accuracy comparable to those obtained by BI-RADS mammography.

Research paper thumbnail of Introduction of a single visit protocol in the management of selected patients with pregnancy of unknown location: a prospective study

Bjog: An International Journal Of Obstetrics And Gynaecology, Feb 18, 2011

Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using... more Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using serum progesterone for the management of women with a pregnancy of unknown location (PUL). Design Prospective interventional study. Population Women with a pregnancy of unknown location and low serum progesterone level. Methods A management protocol was introduced into clinical practice whereby clinically stable patients with PUL and serum progesterone level £ 10 nmol/l were discharged after their initial visit. Patients were advised to contact or attend the early pregnancy unit if they developed abdominal pain or heavy vaginal bleeding. Main outcome measures Need for repeat visits or intervention following discharge. Results In total, 6201 pregnant women were seen during the study period. Of those, 676 (10.9%; 95% CI 10.1-11.7%) had an ultrasound diagnosis of PUL, and 252 of the 676 (37%; 95% CI 33.4-40.9%) had progesterone levels £ 10 nmol/l, and were followed-up by telephone 4 weeks later or by faxing the GP at an interval if the patient failed to respond. Follow-up was completed in 227 of the 252 women (90.1%). In 212 of the 227 women (93.4%; 95% CI 90.68-96.1%) the pregnancy resolved without any complications, whereas 15 women (6.6%; 95% CI, 3.9-9.32%) re-attended because of persistent or worsening symptoms. Only four of the 227 women (1.7%; 95% CI, 0.3-3.2%) required surgical intervention. None of these experienced any significant complications. Conclusions A clinical protocol based on serum progesterone measurements is effective for triaging and managing women with PULs. Implementation of the single-visit protocol into routine practice reduces the need for follow-up of these women without compromising their safety.

Research paper thumbnail of The accuracy of antenatal ultrasound screening in Malta: a population-based study

Journal of the Turkish-German Gynecological Association

Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detectio... more Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detection rates within the private and public sectors, and with the rest of Europe. To assess local trends in accuracy for each organ system. Material and Methods: Ethics approval was obtained to gather routinely collected data from the national congenital anomalies registry between 2016 and 2018. This was analysed to determine local antenatal ultrasound accuracy rates and trends. Electronic medical appointment record data was also used to indirectly determine whether a significant difference existed in the detection of antenatal anomalies in mothers scanned privately and those scanned within the public sector. χ 2-for-trend was used to analyse changes in the accuracy rates. European Surveillance of Congenital Anomalies (EUROCAT) data was used to compare scanning accuracy in Malta and other EUROCAT centres. Results: The local rate of undetected congenital anomalies was 62.0% for public scans and 83.9% for private scans. Local trends over the threeyear period showed an improvement in accuracy rates in detecting isolated syndromes (p=0.05), anomalies of the renal system (p=0.02) and craniofacial anomalies (p=0.05). Malta's overall performance was similar to other EUROCAT centres. Conclusion: Scans carried out within the public sector are more accurate than private scans, and Malta's overall performance was similar to other EUROCAT centres.

Research paper thumbnail of Introduction of a single visit protocol in the management of selected patients with pregnancy of unknown location: a prospective study

BJOG: An International Journal of Obstetrics & Gynaecology, 2011

Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using... more Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using serum progesterone for the management of women with a pregnancy of unknown location (PUL). Design Prospective interventional study. Population Women with a pregnancy of unknown location and low serum progesterone level. Methods A management protocol was introduced into clinical practice whereby clinically stable patients with PUL and serum progesterone level £ 10 nmol/l were discharged after their initial visit. Patients were advised to contact or attend the early pregnancy unit if they developed abdominal pain or heavy vaginal bleeding. Main outcome measures Need for repeat visits or intervention following discharge. Results In total, 6201 pregnant women were seen during the study period. Of those, 676 (10.9%; 95% CI 10.1-11.7%) had an ultrasound diagnosis of PUL, and 252 of the 676 (37%; 95% CI 33.4-40.9%) had progesterone levels £ 10 nmol/l, and were followed-up by telephone 4 weeks later or by faxing the GP at an interval if the patient failed to respond. Follow-up was completed in 227 of the 252 women (90.1%). In 212 of the 227 women (93.4%; 95% CI 90.68-96.1%) the pregnancy resolved without any complications, whereas 15 women (6.6%; 95% CI, 3.9-9.32%) re-attended because of persistent or worsening symptoms. Only four of the 227 women (1.7%; 95% CI, 0.3-3.2%) required surgical intervention. None of these experienced any significant complications. Conclusions A clinical protocol based on serum progesterone measurements is effective for triaging and managing women with PULs. Implementation of the single-visit protocol into routine practice reduces the need for follow-up of these women without compromising their safety.

Research paper thumbnail of Pregnancy Hypertension: An International Journal of Women’s Cardiovascular Health

http://dx.doi.org/10.1016/j.preghy.2015.09.005 2210-7789/ 2015 International Society for the Stud... more http://dx.doi.org/10.1016/j.preghy.2015.09.005 2210-7789/ 2015 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved. Abbreviations: CRH, corticotrophin releasing hormone; FGR, fetal growth restriction; Hb, haemoglobin; Ht, haematocrit; HIE, hypoxic ischaemic encephalopathy; IGF, insulin-like growth factor; IVH, intraventricular haemorrhage; IVF, in-vitro fertilisation; NNU, Neonatal Unit; NEC, necrotising enterocolitis; PE, preeclampsia; PVL, periventricular leucomalacia; RDS, respiratory distress syndrome. Key message: Maternal haemoglobin concentration (Hb) at 27–29 weeks can be used as a continuous variable to predict adverse fetal outcome. The higher the maternal Hb, the higher the risk for FGR and the risk for admission to the NNU. Both high and low Hb increases the risk for adverse neonatal outcome. ⇑ Corresponding author at: Harris Birthright Research Centre for Fetal Medicine, Golden Jubilee Wing – Suite 9, King’s C...

Research paper thumbnail of Pregnancy outcomes in women with previous gestational hypertension: A cohort study to guide counselling and management

Pregnancy hypertension, 2018

In pregnant women with previous gestational hypertension: to compare the prevalence of preeclamps... more In pregnant women with previous gestational hypertension: to compare the prevalence of preeclampsia as defined by the 2001 versus the 2014 International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria, to determine the rates of fetal growth restriction (FGR) as defined, not only by birthweight centile, but in combination with fetal ultrasound studies and, finally, to determine rates of other related outcomes such as gestational diabetes (GDM) and obstetric cholestasis (OC). This was a retrospective observational study based at the Antenatal Hypertension Clinic, Kings College Hospital, London. Routinely collected data of 773 women booked between 2011 and 2016 with a history of gestational hypertension was analysed. All women were normotensive at booking and those with chronic hypertension were excluded. Hypertensive disorders of pregnancy (ISSHP-2014), FGR, GDM. Forty-nine percent developed one or more pregnancy complications, of which 72% were hypertensive disord...

Research paper thumbnail of The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of significant proteinuria in pregnancies at risk of or with established hypertension: an implementation audit and cost implications

Acta Obstetricia et Gynecologica Scandinavica, 2018

The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of signi... more The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of significant proteinuria in pregnancies at risk of or with established hypertension: an implementation audit and cost implications.

Research paper thumbnail of OP 31 The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of significant proteinuria in pregnancies at risk of or with established hypertension – An implementation audit and cost implications

Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health, 2017

Background The replacement of 24-h urine collection by protein-creatinine ratio (PCR) as one of t... more Background The replacement of 24-h urine collection by protein-creatinine ratio (PCR) as one of the diagnostic criteria for pre-eclampsia has been recently recommended. However, the literature is conflicting and there are concerns on the impact of demographic factors on the performance of PCR as a screening tool. Methods This was an implementation audit of the introduction of PCR in a London Tertiary obstetric unit. Women with suspected pre-eclampsia (N = 476) were asked to complete a 24-h urine collection and an untimed urine sample for PCR calculation. Multivariate logistic regression was used to assess the independent predictors of significant proteinuria. Results In a pregnant population ethnicity and PCR are the main predictors of 300 mg or more of proteinuria in a 24-h urine collection. With a PCR cut-off of 30 mg/mmol, 41.4% and 22.9% of black and non-black women, respectively, would have been incorrectly classified as non-proteinuric. Sensitivity of 100% is achieved at cut-offs of 8.67 and 20.56 mg/mmol for black and non-black women, respectively. Applying these levels as a primary screening tool to inform for the need to perform a 24-h urine collection in 1000 women, it would lead to a financial saving of £2587 in non-black and to a loss of £2905 black women, respectively. Conclusions PCR has 100% sensitivity and is cost efficient in non-black pregnant women, at a cut-off of 20.5 mg/mmol, in the detection of more than 300 mg in a 24-h urine collection. However, in black pregnant populations the performance of PCR is both clinically and financially suboptimal. Download : Download high-res image (77KB) Download : Download full-size image Download : Download high-res image (133KB) Download : Download full-size image

Research paper thumbnail of P 34 Does performance of mean arterial blood pressure for the screening of preeclampsia improve after controlling for the use of anti-hypertensive medication?

Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health, 2017

Question Mean arterial pressure (MAP) is a useful biomarker for the screening of preeclampsia (PE... more Question Mean arterial pressure (MAP) is a useful biomarker for the screening of preeclampsia (PE). However, MAP, a function of cardiac output and peripheral resistance, is dependent on other maternal characteristics and, for its effective use in screening, these need to be taken into account. One such characteristic is the use of anti-hypertensive medication. The aim of our study was to evaluate the impact of the use of anti-hypertensive medication on the performance of MAP as a screening tool for PE in pregnant women with chronic hypertension or a history of gestational hypertension. Methods A retrospective study was conducted on women with chronic hypertension (N = 478) and normotensive women with a history of gestational hypertension (N = 511) who booked with the Antenatal Hypertension Clinic, Kings College Hospital, London, between 2009–2016. Blood pressure was measured repeatedly antenatally using an automated device validated for use in pregnancy and PE. The more updated International Society for the Study of Hypertension in Pregnancy (ISSHP)-2014 definition of PE was used. We constructed probit Receiver Operating Characteristic Curves (ROC) models to determine the predictive capacity of MAP in women taking anti-hypertensive medication and in those who were not. Wald tests of the null hypothesis that the two ROC curves are equal at different false-positive rates were performed. Age and medication use were taken into account in the comparisons. Results The area under the curves (AUC) for the prediction of PE (p = Conclusion The ability of MAP to predict PE and renal dysfunction is significantly improved by controlling for the use of anti-hypertensive medication in a high-risk pregnant population.

Research paper thumbnail of The use of amniotic fluid index vs deepest vertical pool in the Maltese population

European Journal of Obstetrics & Gynecology and Reproductive Biology, 2016

Research paper thumbnail of Association between maternal haemoglobin at 27–29weeks gestation and intrauterine growth restriction

Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health, 2015

To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29weeks&amp... more To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29weeks' gestation and fetal growth restriction (FGR). This was a retrospective, case control study. A University hospital in London, UK. Pregnant women attending for routine antenatal care at 27-29weeks of pregnancy. Maternal Hb, measured routinely at 27-29weeks in pregnancies complicated by FGR (n=491) was compared to normal controls (n=491). Multiple regression analysis was used to examine the association between Hb and maternal characteristics. Birthweight z-score, admission to the Neonatal Unit (NNU) and adverse perinatal outcome. Increased Hb at 27-29weeks gestation is associated with reduced birthweight, with an inverse relationship between maternal Hb and fetal birthweight z-score (R(2)=0.10, p<0.0001). In addition, for the prediction of admission to the NNU (R(2)=0.24, p<0.0001) and serious adverse neonatal outcome (R(2)=0.10, p<0.0001), maternal Hb is an independent predictor with a linear and quadratic relationship, respectively. Therefore, both increased and decreased maternal Hb levels increase the risk of serious neonatal complications. Raised Hb at 27-29weeks gestation is associated with FGR and with an increased risk of admission to the NNU and adverse fetal outcome.

Research paper thumbnail of Maternal haemoglobin at 27-29 weeks’ gestation and severity of pre-eclampsia

Journal of Maternal-Fetal and Neonatal Medicine, 2015

The reader is advised to check the appropriate medical literature and the product information cur... more The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient.

Research paper thumbnail of Post-Menopausal Bleeding: A Case of Vaginal Malignant Melanoma

A 68 year old postmenopausal lady was referred for vaginoscopy of a vaginal lesion. The lesions w... more A 68 year old postmenopausal lady was referred for vaginoscopy of a vaginal lesion. The lesions were violaceous in colour, maculopapular and friable with a maximum diameter of 20 mm. Histological biopsy showed malignant melanoma cells with strongly positive Melanin A staining and brisk mitotic activity. Cells with prominent red nucleoli with eosinophilic cytoplasm were noted. A radical vulvectomy was performed 2 weeks after the initial diagnosis and the patient recovered well. Tumour histology showed a completely resected multifocal melanoma in situ with minimal focal microinvasion. The tumour was clear of all excision margins. Discussion: 2% of the female genital tract malignancies are accounted for by vaginal carcinomas. Malignant melanoma accounts for 10% of such cases, with only 250 cases being described. White women have a higher incidence of such malignancy. Conservative local excisions give a comparable survival rate, comparing well with radical pelvic exenteration combined w...

Research paper thumbnail of Is There a Role for Hyperglycosylated hCG in the Diagnosis of Ectopic Pregnancy in Women with a Pregnancy of Unknown Location?

The Journal of reproductive medicine, 2017

OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identi... more OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identifying ectopic pregnancies in pregnancies of unknown location (PULs) on ultrasound scan. STUDY DESIGN: This was a prospective observational study. An additional blood sample was taken from women whose initial transvaginal ultrasound scan showed none of the following: intact intrauterine pregnancy, retained placental tissue, or ectopic pregnancy. Parallel sandwich ELISAs were performed using sheep monoclonal antibodies to the 12F6 epitope for detection of total hCG and to the 4D8 epitope for hCG-H detection, and an automated immunoassay technique was used for progesterone and serum β-hCG measurements. Patients were managed accord-ing to our standard clinical protocol. RESULTS: hCG-H was significantly higher in ectopic pregnancies (85.6 ng/mL) than in viable intrauterine pregnancies (26.8 ng/mL) and spontaneously resolving pregnancies (23.2 ng/mL). The ability to distinguish ectopic pregnan...

Research paper thumbnail of Sildenafil use in twin IUGR pregnancy

European Journal of Obstetrics & Gynecology and Reproductive Biology

Research paper thumbnail of Maternal haemoglobin at 27-29 weeks’ gestation and severity of pre-eclampsia

Journal of Maternal-Fetal and Neonatal Medicine, 2014

Objective. To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29 w... more Objective. To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29 weeks' gestation and severity of pre-eclampsia (PE).

Research paper thumbnail of Clinical use of a model to predict the viability of early intrauterine pregnancies when no embryo is visible on ultrasound

Human Reproduction, 2011

When a small gestational sac with no visible embryo is seen at an early pregnancy ultrasound scan... more When a small gestational sac with no visible embryo is seen at an early pregnancy ultrasound scan, the clinician cannot distinguish a viable from a non-viable pregnancy. A test for the prediction of early pregnancy viability at the initial visit was developed in 2003. Maternal age, gestational sac diameter (GSD) and serum progesterone levels were used in a logistic regression model to create an algorithm for estimation of the probability of a viable pregnancy. The objective of this study was to assess how well the test performed in routine clinical practice. This is a retrospective observational study of women who had the test performed in our Early Pregnancy Unit over a 6-year period. Inclusion criteria were a spontaneous conception, gestational sac of <20 mm mean diameter, no visible embryo on transvaginal ultrasound scan and outcome data regarding the viability of the pregnancy. Of 5163 potentially eligible women, 472 had the test performed (9.1%) and 400 met the inclusion criteria for the study. Women who were older or with vaginal bleeding, a more advanced gestational age or a history of previous first trimester miscarriages were more likely to have the test performed. At follow-up, 199/400 (49.8%) women had a viable intrauterine pregnancy, and 201/400 (50.2%) had a non-viable pregnancy. The logistic regression model performed better than serum progesterone, β-hCG, mean GSD or maternal age alone as single parameters to differentiate between viable and non-viable pregnancies, but the area under the curve was lower than in the 2003 study [0.85 (standard error 0.021) versus 0.97 (standard error 0.011)]. Although less effective than in the original study, the logistic regression model was able to predict pregnancy viability with reasonable accuracy when applied in clinical practice. The test appears to be under utilized and further prospective studies are needed to establish if the test is of clinical benefit, for example, in reducing patient anxiety.

Research paper thumbnail of The accuracy of antenatal ultrasound screening in Malta: a population-based study

Journal of the Turkish-German Gynecological Association, Dec 1, 2022

Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detectio... more Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detection rates within the private and public sectors, and with the rest of Europe. To assess local trends in accuracy for each organ system. Material and Methods: Ethics approval was obtained to gather routinely collected data from the national congenital anomalies registry between 2016 and 2018. This was analysed to determine local antenatal ultrasound accuracy rates and trends. Electronic medical appointment record data was also used to indirectly determine whether a significant difference existed in the detection of antenatal anomalies in mothers scanned privately and those scanned within the public sector. χ 2-for-trend was used to analyse changes in the accuracy rates. European Surveillance of Congenital Anomalies (EUROCAT) data was used to compare scanning accuracy in Malta and other EUROCAT centres. Results: The local rate of undetected congenital anomalies was 62.0% for public scans and 83.9% for private scans. Local trends over the threeyear period showed an improvement in accuracy rates in detecting isolated syndromes (p=0.05), anomalies of the renal system (p=0.02) and craniofacial anomalies (p=0.05). Malta's overall performance was similar to other EUROCAT centres. Conclusion: Scans carried out within the public sector are more accurate than private scans, and Malta's overall performance was similar to other EUROCAT centres.

Research paper thumbnail of Is There a Role for Hyperglycosylated hCG in the Diagnosis of Ectopic Pregnancy in Women with a Pregnancy of Unknown Location?

PubMed, 2017

OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identi... more OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identifying ectopic pregnancies in pregnancies of unknown location (PULs) on ultrasound scan. STUDY DESIGN: This was a prospective observational study. An additional blood sample was taken from women whose initial transvaginal ultrasound scan showed none of the following: intact intrauterine pregnancy, retained placental tissue, or ectopic pregnancy. Parallel sandwich ELISAs were performed using sheep monoclonal antibodies to the 12F6 epitope for detection of total hCG and to the 4D8 epitope for hCG-H detection, and an automated immunoassay technique was used for progesterone and serum β-hCG measurements. Patients were managed accord-ing to our standard clinical protocol. RESULTS: hCG-H was significantly higher in ectopic pregnancies (85.6 ng/mL) than in viable intrauterine pregnancies (26.8 ng/mL) and spontaneously resolving pregnancies (23.2 ng/mL). The ability to distinguish ectopic pregnancies from nonectopic pregnancies, expressed as area under the curve, was 0.816 for hCG-H and 0.824 for total hCG. CONCLUSION: Women with an underlying ectopic pregnancy tended to have higher hCGs, whichever assay was used. However, the current study does not support a role for a single measurement of hCG-H in the diagnosis of ectopic pregnancy within the PUL population.

Research paper thumbnail of Anomaly Scans – a 1 year plus review at Mater Dei Hospital Obstetric Unit

European Journal of Obstetrics & Gynecology and Reproductive Biology, 2016

The diagnosis of gestational diabetes mellitus (GDM) in Malta is based on the American Diabetes A... more The diagnosis of gestational diabetes mellitus (GDM) in Malta is based on the American Diabetes Association (ADA) guidelines. International Association of Diabetes and Pregnancy Study Group (IADPSG) guidelines have more stringent criteria for diagnosis. The aim of this audit was to assess adherence of current practice to ADA guidelines. Patients whose random blood glucose (RBG) levels fell under IADPSG criteria were also reviewed to identify patients diagnosed with GDM otherwise not identified on the basis of ADA criteria. Methods: The medical data of patients attending for a booking visit in April and May 2014 at Mater Dei Hospital was reviewed. Blood results were obtained from iSoft clinical manager, focusing on the booking RBG, follow-up fasting blood glucose (FBG) and oral glucose tolerance test (oGTT). Results: Out of a total of 819 cases, 13 patients had an RBG above the upper limit set by ADA. Out of these, 3 patients were followed up with an FBG and 4 with an oGTT and 3 patients had no follow-up blood glucose testing done. A follow-up postpartum oGTT was done for only one patient. 355 patients were identified to have an RBG level above the upper limit of the IADPSG guidelines; 35 patients had an oGTT, out of which 13 patients would be classified as having GDM. Conclusion: Lack of adherence to ADA guidelines for GDM screening was noted. Moreover, GDM was diagnosed in patients who did not fall under ADA criteria for screening, questioning their suitability for the Maltese population.

Research paper thumbnail of OC05.07: Introduction of a modified protocol for the management of patients with pregnancy of unknown location

Ultrasound in Obstetrics and Gynecology, 2009

Introduction: ACR has developed a BI-RADS lexicon of the breast sonography in order to standardiz... more Introduction: ACR has developed a BI-RADS lexicon of the breast sonography in order to standardize the characterization of sonographic breast lesions. Purpose: To analyze the accuracy of the categorization of sono-mammographic results according to the BI-RADS use criteria and breast cancer. Methods: In the period of 2002-2008, in our policlinic sonomammography was performed on 2719 patients. Sonographic findings are categorized according to respective criteria of BI-RADS sono-mammography. Every change has been described by use of these features and is classified in categories from 1 to 5, according to BI-RADS for sono-mammography. Categorization and biopsy results have been compared. Results: In 32 (1.2%) patients, sono-mammography could not be assessed due to the extreme tissue density. Categorization 1normal was found in 758 (27.9%) patients. Simple cysts classified as category 2 are found in 988 (36.3%) women. In 567 (20.9%) patients suspicious benign solid masses have been found categorized as category 3. Local suspicious processes for the malignant process categorized as category 4 are found in 234 (8.6%) women and local processes suggest high malignity possibility categorized as category 5 is found in 140 (5.1%) patients. Histological results were possible in 37 (6.5%) masses that are classified by BI-RADS as category 3, in 102 (43.5%) of the category 4, and 129 (92.1%) of the category 5. The level of malignant findings was: 2.7% (n=1) in category 3, 17.6% (n=18) in category 4 and 92.2% (n=119) in category 5. For the category 4, OR=7.7, 95% CI 0.991-60.02. For the category 5 OR=428.4, 95% CI 53.0-3462.5. Conclusion: The assessment of findings during malignity sonomammography based on criteria used by BI-RADS of the breast sonography, has high level accuracy comparable to those obtained by BI-RADS mammography.

Research paper thumbnail of Introduction of a single visit protocol in the management of selected patients with pregnancy of unknown location: a prospective study

Bjog: An International Journal Of Obstetrics And Gynaecology, Feb 18, 2011

Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using... more Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using serum progesterone for the management of women with a pregnancy of unknown location (PUL). Design Prospective interventional study. Population Women with a pregnancy of unknown location and low serum progesterone level. Methods A management protocol was introduced into clinical practice whereby clinically stable patients with PUL and serum progesterone level £ 10 nmol/l were discharged after their initial visit. Patients were advised to contact or attend the early pregnancy unit if they developed abdominal pain or heavy vaginal bleeding. Main outcome measures Need for repeat visits or intervention following discharge. Results In total, 6201 pregnant women were seen during the study period. Of those, 676 (10.9%; 95% CI 10.1-11.7%) had an ultrasound diagnosis of PUL, and 252 of the 676 (37%; 95% CI 33.4-40.9%) had progesterone levels £ 10 nmol/l, and were followed-up by telephone 4 weeks later or by faxing the GP at an interval if the patient failed to respond. Follow-up was completed in 227 of the 252 women (90.1%). In 212 of the 227 women (93.4%; 95% CI 90.68-96.1%) the pregnancy resolved without any complications, whereas 15 women (6.6%; 95% CI, 3.9-9.32%) re-attended because of persistent or worsening symptoms. Only four of the 227 women (1.7%; 95% CI, 0.3-3.2%) required surgical intervention. None of these experienced any significant complications. Conclusions A clinical protocol based on serum progesterone measurements is effective for triaging and managing women with PULs. Implementation of the single-visit protocol into routine practice reduces the need for follow-up of these women without compromising their safety.

Research paper thumbnail of The accuracy of antenatal ultrasound screening in Malta: a population-based study

Journal of the Turkish-German Gynecological Association

Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detectio... more Objective: To analyse the accuracy of antenatal ultrasound screening in Malta, comparing detection rates within the private and public sectors, and with the rest of Europe. To assess local trends in accuracy for each organ system. Material and Methods: Ethics approval was obtained to gather routinely collected data from the national congenital anomalies registry between 2016 and 2018. This was analysed to determine local antenatal ultrasound accuracy rates and trends. Electronic medical appointment record data was also used to indirectly determine whether a significant difference existed in the detection of antenatal anomalies in mothers scanned privately and those scanned within the public sector. χ 2-for-trend was used to analyse changes in the accuracy rates. European Surveillance of Congenital Anomalies (EUROCAT) data was used to compare scanning accuracy in Malta and other EUROCAT centres. Results: The local rate of undetected congenital anomalies was 62.0% for public scans and 83.9% for private scans. Local trends over the threeyear period showed an improvement in accuracy rates in detecting isolated syndromes (p=0.05), anomalies of the renal system (p=0.02) and craniofacial anomalies (p=0.05). Malta's overall performance was similar to other EUROCAT centres. Conclusion: Scans carried out within the public sector are more accurate than private scans, and Malta's overall performance was similar to other EUROCAT centres.

Research paper thumbnail of Introduction of a single visit protocol in the management of selected patients with pregnancy of unknown location: a prospective study

BJOG: An International Journal of Obstetrics & Gynaecology, 2011

Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using... more Objective To prospectively evaluate the efficacy and safety of a modified clinical protocol using serum progesterone for the management of women with a pregnancy of unknown location (PUL). Design Prospective interventional study. Population Women with a pregnancy of unknown location and low serum progesterone level. Methods A management protocol was introduced into clinical practice whereby clinically stable patients with PUL and serum progesterone level £ 10 nmol/l were discharged after their initial visit. Patients were advised to contact or attend the early pregnancy unit if they developed abdominal pain or heavy vaginal bleeding. Main outcome measures Need for repeat visits or intervention following discharge. Results In total, 6201 pregnant women were seen during the study period. Of those, 676 (10.9%; 95% CI 10.1-11.7%) had an ultrasound diagnosis of PUL, and 252 of the 676 (37%; 95% CI 33.4-40.9%) had progesterone levels £ 10 nmol/l, and were followed-up by telephone 4 weeks later or by faxing the GP at an interval if the patient failed to respond. Follow-up was completed in 227 of the 252 women (90.1%). In 212 of the 227 women (93.4%; 95% CI 90.68-96.1%) the pregnancy resolved without any complications, whereas 15 women (6.6%; 95% CI, 3.9-9.32%) re-attended because of persistent or worsening symptoms. Only four of the 227 women (1.7%; 95% CI, 0.3-3.2%) required surgical intervention. None of these experienced any significant complications. Conclusions A clinical protocol based on serum progesterone measurements is effective for triaging and managing women with PULs. Implementation of the single-visit protocol into routine practice reduces the need for follow-up of these women without compromising their safety.

Research paper thumbnail of Pregnancy Hypertension: An International Journal of Women’s Cardiovascular Health

http://dx.doi.org/10.1016/j.preghy.2015.09.005 2210-7789/ 2015 International Society for the Stud... more http://dx.doi.org/10.1016/j.preghy.2015.09.005 2210-7789/ 2015 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved. Abbreviations: CRH, corticotrophin releasing hormone; FGR, fetal growth restriction; Hb, haemoglobin; Ht, haematocrit; HIE, hypoxic ischaemic encephalopathy; IGF, insulin-like growth factor; IVH, intraventricular haemorrhage; IVF, in-vitro fertilisation; NNU, Neonatal Unit; NEC, necrotising enterocolitis; PE, preeclampsia; PVL, periventricular leucomalacia; RDS, respiratory distress syndrome. Key message: Maternal haemoglobin concentration (Hb) at 27–29 weeks can be used as a continuous variable to predict adverse fetal outcome. The higher the maternal Hb, the higher the risk for FGR and the risk for admission to the NNU. Both high and low Hb increases the risk for adverse neonatal outcome. ⇑ Corresponding author at: Harris Birthright Research Centre for Fetal Medicine, Golden Jubilee Wing – Suite 9, King’s C...

Research paper thumbnail of Pregnancy outcomes in women with previous gestational hypertension: A cohort study to guide counselling and management

Pregnancy hypertension, 2018

In pregnant women with previous gestational hypertension: to compare the prevalence of preeclamps... more In pregnant women with previous gestational hypertension: to compare the prevalence of preeclampsia as defined by the 2001 versus the 2014 International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria, to determine the rates of fetal growth restriction (FGR) as defined, not only by birthweight centile, but in combination with fetal ultrasound studies and, finally, to determine rates of other related outcomes such as gestational diabetes (GDM) and obstetric cholestasis (OC). This was a retrospective observational study based at the Antenatal Hypertension Clinic, Kings College Hospital, London. Routinely collected data of 773 women booked between 2011 and 2016 with a history of gestational hypertension was analysed. All women were normotensive at booking and those with chronic hypertension were excluded. Hypertensive disorders of pregnancy (ISSHP-2014), FGR, GDM. Forty-nine percent developed one or more pregnancy complications, of which 72% were hypertensive disord...

Research paper thumbnail of The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of significant proteinuria in pregnancies at risk of or with established hypertension: an implementation audit and cost implications

Acta Obstetricia et Gynecologica Scandinavica, 2018

The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of signi... more The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of significant proteinuria in pregnancies at risk of or with established hypertension: an implementation audit and cost implications.

Research paper thumbnail of OP 31 The effect of ethnicity on the performance of protein-creatinine ratio in the prediction of significant proteinuria in pregnancies at risk of or with established hypertension – An implementation audit and cost implications

Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health, 2017

Background The replacement of 24-h urine collection by protein-creatinine ratio (PCR) as one of t... more Background The replacement of 24-h urine collection by protein-creatinine ratio (PCR) as one of the diagnostic criteria for pre-eclampsia has been recently recommended. However, the literature is conflicting and there are concerns on the impact of demographic factors on the performance of PCR as a screening tool. Methods This was an implementation audit of the introduction of PCR in a London Tertiary obstetric unit. Women with suspected pre-eclampsia (N = 476) were asked to complete a 24-h urine collection and an untimed urine sample for PCR calculation. Multivariate logistic regression was used to assess the independent predictors of significant proteinuria. Results In a pregnant population ethnicity and PCR are the main predictors of 300 mg or more of proteinuria in a 24-h urine collection. With a PCR cut-off of 30 mg/mmol, 41.4% and 22.9% of black and non-black women, respectively, would have been incorrectly classified as non-proteinuric. Sensitivity of 100% is achieved at cut-offs of 8.67 and 20.56 mg/mmol for black and non-black women, respectively. Applying these levels as a primary screening tool to inform for the need to perform a 24-h urine collection in 1000 women, it would lead to a financial saving of £2587 in non-black and to a loss of £2905 black women, respectively. Conclusions PCR has 100% sensitivity and is cost efficient in non-black pregnant women, at a cut-off of 20.5 mg/mmol, in the detection of more than 300 mg in a 24-h urine collection. However, in black pregnant populations the performance of PCR is both clinically and financially suboptimal. Download : Download high-res image (77KB) Download : Download full-size image Download : Download high-res image (133KB) Download : Download full-size image

Research paper thumbnail of P 34 Does performance of mean arterial blood pressure for the screening of preeclampsia improve after controlling for the use of anti-hypertensive medication?

Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health, 2017

Question Mean arterial pressure (MAP) is a useful biomarker for the screening of preeclampsia (PE... more Question Mean arterial pressure (MAP) is a useful biomarker for the screening of preeclampsia (PE). However, MAP, a function of cardiac output and peripheral resistance, is dependent on other maternal characteristics and, for its effective use in screening, these need to be taken into account. One such characteristic is the use of anti-hypertensive medication. The aim of our study was to evaluate the impact of the use of anti-hypertensive medication on the performance of MAP as a screening tool for PE in pregnant women with chronic hypertension or a history of gestational hypertension. Methods A retrospective study was conducted on women with chronic hypertension (N = 478) and normotensive women with a history of gestational hypertension (N = 511) who booked with the Antenatal Hypertension Clinic, Kings College Hospital, London, between 2009–2016. Blood pressure was measured repeatedly antenatally using an automated device validated for use in pregnancy and PE. The more updated International Society for the Study of Hypertension in Pregnancy (ISSHP)-2014 definition of PE was used. We constructed probit Receiver Operating Characteristic Curves (ROC) models to determine the predictive capacity of MAP in women taking anti-hypertensive medication and in those who were not. Wald tests of the null hypothesis that the two ROC curves are equal at different false-positive rates were performed. Age and medication use were taken into account in the comparisons. Results The area under the curves (AUC) for the prediction of PE (p = Conclusion The ability of MAP to predict PE and renal dysfunction is significantly improved by controlling for the use of anti-hypertensive medication in a high-risk pregnant population.

Research paper thumbnail of The use of amniotic fluid index vs deepest vertical pool in the Maltese population

European Journal of Obstetrics & Gynecology and Reproductive Biology, 2016

Research paper thumbnail of Association between maternal haemoglobin at 27–29weeks gestation and intrauterine growth restriction

Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health, 2015

To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29weeks&amp... more To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29weeks' gestation and fetal growth restriction (FGR). This was a retrospective, case control study. A University hospital in London, UK. Pregnant women attending for routine antenatal care at 27-29weeks of pregnancy. Maternal Hb, measured routinely at 27-29weeks in pregnancies complicated by FGR (n=491) was compared to normal controls (n=491). Multiple regression analysis was used to examine the association between Hb and maternal characteristics. Birthweight z-score, admission to the Neonatal Unit (NNU) and adverse perinatal outcome. Increased Hb at 27-29weeks gestation is associated with reduced birthweight, with an inverse relationship between maternal Hb and fetal birthweight z-score (R(2)=0.10, p<0.0001). In addition, for the prediction of admission to the NNU (R(2)=0.24, p<0.0001) and serious adverse neonatal outcome (R(2)=0.10, p<0.0001), maternal Hb is an independent predictor with a linear and quadratic relationship, respectively. Therefore, both increased and decreased maternal Hb levels increase the risk of serious neonatal complications. Raised Hb at 27-29weeks gestation is associated with FGR and with an increased risk of admission to the NNU and adverse fetal outcome.

Research paper thumbnail of Maternal haemoglobin at 27-29 weeks’ gestation and severity of pre-eclampsia

Journal of Maternal-Fetal and Neonatal Medicine, 2015

The reader is advised to check the appropriate medical literature and the product information cur... more The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient.

Research paper thumbnail of Post-Menopausal Bleeding: A Case of Vaginal Malignant Melanoma

A 68 year old postmenopausal lady was referred for vaginoscopy of a vaginal lesion. The lesions w... more A 68 year old postmenopausal lady was referred for vaginoscopy of a vaginal lesion. The lesions were violaceous in colour, maculopapular and friable with a maximum diameter of 20 mm. Histological biopsy showed malignant melanoma cells with strongly positive Melanin A staining and brisk mitotic activity. Cells with prominent red nucleoli with eosinophilic cytoplasm were noted. A radical vulvectomy was performed 2 weeks after the initial diagnosis and the patient recovered well. Tumour histology showed a completely resected multifocal melanoma in situ with minimal focal microinvasion. The tumour was clear of all excision margins. Discussion: 2% of the female genital tract malignancies are accounted for by vaginal carcinomas. Malignant melanoma accounts for 10% of such cases, with only 250 cases being described. White women have a higher incidence of such malignancy. Conservative local excisions give a comparable survival rate, comparing well with radical pelvic exenteration combined w...

Research paper thumbnail of Is There a Role for Hyperglycosylated hCG in the Diagnosis of Ectopic Pregnancy in Women with a Pregnancy of Unknown Location?

The Journal of reproductive medicine, 2017

OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identi... more OBJECTIVE: To examine the potential use of hyperglycosylated human gonadotropin (hCG-H) in identifying ectopic pregnancies in pregnancies of unknown location (PULs) on ultrasound scan. STUDY DESIGN: This was a prospective observational study. An additional blood sample was taken from women whose initial transvaginal ultrasound scan showed none of the following: intact intrauterine pregnancy, retained placental tissue, or ectopic pregnancy. Parallel sandwich ELISAs were performed using sheep monoclonal antibodies to the 12F6 epitope for detection of total hCG and to the 4D8 epitope for hCG-H detection, and an automated immunoassay technique was used for progesterone and serum β-hCG measurements. Patients were managed accord-ing to our standard clinical protocol. RESULTS: hCG-H was significantly higher in ectopic pregnancies (85.6 ng/mL) than in viable intrauterine pregnancies (26.8 ng/mL) and spontaneously resolving pregnancies (23.2 ng/mL). The ability to distinguish ectopic pregnan...

Research paper thumbnail of Sildenafil use in twin IUGR pregnancy

European Journal of Obstetrics & Gynecology and Reproductive Biology

Research paper thumbnail of Maternal haemoglobin at 27-29 weeks’ gestation and severity of pre-eclampsia

Journal of Maternal-Fetal and Neonatal Medicine, 2014

Objective. To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29 w... more Objective. To examine the relationship between maternal haemoglobin concentration (Hb) at 27-29 weeks' gestation and severity of pre-eclampsia (PE).

Research paper thumbnail of Clinical use of a model to predict the viability of early intrauterine pregnancies when no embryo is visible on ultrasound

Human Reproduction, 2011

When a small gestational sac with no visible embryo is seen at an early pregnancy ultrasound scan... more When a small gestational sac with no visible embryo is seen at an early pregnancy ultrasound scan, the clinician cannot distinguish a viable from a non-viable pregnancy. A test for the prediction of early pregnancy viability at the initial visit was developed in 2003. Maternal age, gestational sac diameter (GSD) and serum progesterone levels were used in a logistic regression model to create an algorithm for estimation of the probability of a viable pregnancy. The objective of this study was to assess how well the test performed in routine clinical practice. This is a retrospective observational study of women who had the test performed in our Early Pregnancy Unit over a 6-year period. Inclusion criteria were a spontaneous conception, gestational sac of <20 mm mean diameter, no visible embryo on transvaginal ultrasound scan and outcome data regarding the viability of the pregnancy. Of 5163 potentially eligible women, 472 had the test performed (9.1%) and 400 met the inclusion criteria for the study. Women who were older or with vaginal bleeding, a more advanced gestational age or a history of previous first trimester miscarriages were more likely to have the test performed. At follow-up, 199/400 (49.8%) women had a viable intrauterine pregnancy, and 201/400 (50.2%) had a non-viable pregnancy. The logistic regression model performed better than serum progesterone, β-hCG, mean GSD or maternal age alone as single parameters to differentiate between viable and non-viable pregnancies, but the area under the curve was lower than in the 2003 study [0.85 (standard error 0.021) versus 0.97 (standard error 0.011)]. Although less effective than in the original study, the logistic regression model was able to predict pregnancy viability with reasonable accuracy when applied in clinical practice. The test appears to be under utilized and further prospective studies are needed to establish if the test is of clinical benefit, for example, in reducing patient anxiety.