Introduction and aims Objective structured clinical examinations (OSCEs) are an integral part of medical education assessment. The advanced clinical skills (ACS) OSCE examines clinical skills in psychiatry, general practice, obstetrics and gynaecology and paediatrics for fourth-year medical students at the University of Galway. This study compares results between the 2019 OSCE, and two subsequent OSCEs (2020 and 2021) modified to varying degrees secondary to the COVID-19 pandemic. We also examined student’s satisfaction and perspectives regarding both modified OSCEs. Materials and methods Anonymised results between the 2019 (128 min), 2020 (56 min) and 2021 (96 min) ACS OSCEs were compared, and student feedback pertaining to the 2020 and 2021 OSCEs was analysed. Results A higher total mean mark OSCE result was achieved at the 2020 OSCE (62.95%) compared to the 2019 (59.35%) and 2021 (58.89%) OSCEs ( F = 31.83, p < 0.001), with significantly more first-class honours marks attained in 2020 (11.5%) compared to 2019 and 2021 (both 1%) ( p < 0.001). Measures of reliability were consistent across all years. A majority of students in both 2020 and 2021 reported the OSCE to be safe, well-coordinated, and fair, but similar numbers of students from both 2020 and 2021 expressed concern that face masks impeded their communication skills. Conclusion This study demonstrates the feasibility of conducting a modified reliable OSCE during a pandemic. Conducting a 96-min OSCE demonstrated similar results to the pre-COVID-19 pandemic 128-min OSCE, in contrast to a 56-min OSCE where potentially inflated marks were attained.

ABSTRACTObjectiveTo establish whether digital foetal scalp stimulation (dFSS) performs better than foetal blood sampling (FBS) in terms of reducing the rate of caesarean section (CS) in labour, without adversely affecting perinatal outcomes.DesignA multicentre parallel‐group randomised controlled trial.SettingMaternity centres in Ireland.PopulationThe study aimed to randomise 2500 nulliparous women who required a second‐line test of foetal well‐being in labour due to abnormal cardiotocography (CTG).MethodsParticipants were randomly allocated to dFSS or FBS in a 1:1 ratio. Analysis was according to the published protocol and included a meta‐analysis of the pilot study data and trial data.Main Outcome MeasuresThe primary outcome was CS.ResultsDue to lower‐than‐expected randomisations, the trial concluded early. Of 534 consented participants, 124 had a second‐line test of foetal well‐being in labour and 43 (34.7%) were randomised; 20 to dFSS and 23 to FBS. The rate of CS was 40.0% (8/20) in the dFSS group and 47.8% (11/23) in the FBS group (absolute difference 7.8%; OR 0.73, 95% CI 0.22–2.44). The rate of CS was lower in the dFSS group when the trial data were included in a meta‐analysis with the pilot data (n = 50), although the confidence limits were wide (OR 0.41, 95% CI 0.17–0.96). There was no significant difference in rates of adverse perinatal and maternal outcomes. Of the nonrandomised participants who received a second‐line test, 65% (53/81) received dFSS.ConclusionsThe small sample size limits the ability to conclude whether dFSS performs better as a second‐line test of foetal well‐being in labour than FBS. A clinician preference for dFSS was apparent, even though robust evidence is lacking.Trial Registration: This trial was prospectively registered on ClinicalTrials.gov on the 31st of March 2022. ClinicalTrials.gov Identifier: NCT05306756 (Access at https://clinicaltrials.gov/study/NCT05306756?cond=fetal%20blood%20sampling&rank=3)

( JAMA . 2023;330(16):1547–1556. doi: 10.1001/jama.2023.19869) Gestational diabetes (gDM) is a common pregnancy complication, affecting up to nearly 3 million pregnancies globally every year. It is known to be associated with adverse pregnancy outcomes, including weight gain, cesarean delivery, preeclampsia, birth injuries, respiratory distress, and neonatal ICU admission. Optimal management of gDM is unclear. Current guidelines recommend lifestyle modifications with nutrition and exercise, and subsequent insulin administration if hyperglycemia persists. Although effective in improving outcomes, insulin is linked to increased hypoglycemia events, weight gain, cesarean delivery, and neonatal ICU admission. Metformin in pregnancy is also associated with improved maternal and fetal outcomes compared to insulin, although there are concerns relating to spontaneous preterm birth and small for gestational age infants. Though metformin is considered safe during pregnancy, it is currently only prescribed after lifestyle management failure; this study was designed to test the hypothesis that earlier administration of metformin upon diagnosis of gDM would be beneficial to the outcomes of mothers and babies, primarily assessing the effect on the composite of insulin initiation and fasting hyperglycemia at 32 or 38 weeks of gestation.

BACKGROUNDAlthough aspirin therapy is being increasingly advocated with the intention of risk modification for a wide range of pregnancy complications, women with prepregnancy diabetes mellitus are commonly excluded from clinical trials.OBJECTIVEThe primary aim of this study was to examine the effect of aspirin therapy on a composite measure of adverse perinatal outcome in pregnancies complicated by pregestational diabetes mellitus.STUDY DESIGNA double-blinded, placebo-controlled randomized trial was conducted at 6 university-affiliated perinatology centers. Women with type 1 diabetes mellitus or type 2 diabetes mellitus of at least 6 months’ duration were randomly allocated to 150-mg daily aspirin or placebo from 11 to 14 weeks’ gestation until 36 weeks. Established vascular complications of diabetes mellitus, including chronic hypertension or nephropathy, led to exclusion from the trial. The primary outcome was a composite measure of placental dysfunction (preeclampsia, fetal growth restriction, preterm birth <34 weeks’ gestation, or perinatal mortality). The planned sample size was 566 participants to achieve a 35% reduction in the primary outcome, assuming 80% statistical power. Secondary end points included maternal and neonatal outcomes and determination of insulin requirements across gestation. Data were centrally managed using ClinInfo and analyzed using SAS 9.4. The 2 treatment groups were compared using t tests or chi-square tests, as required, and longitudinal data were compared using a repeated-measures analysis.RESULTSFrom February 2020 to September 2022, 191 patients were deemed eligible, 134 of whom were enrolled (67 randomized to aspirin and 67 to placebo) with a retrospective power of 64%. A total of 101 (80%) women had type 1 diabetes mellitus and 25 (20%) had type 2 diabetes mellitus. Reaching the target sample size was limited by the impact of the COVID-19 pandemic. Baseline characteristics were similar between the aspirin and placebo groups. Treatment compliance was very high and similar between groups (97% for aspirin, 94% for placebo). The risk of the composite measure of placental dysfunction did not differ between groups (25% aspirin vs 21% placebo; P=.796). Women in the aspirin group had significantly lower insulin requirements throughout pregnancy compared with the placebo group. Insulin requirements in the aspirin group increased on average from 0.7 units/kg at baseline to 1.1 units/kg by 36 weeks’ gestation (an average 83% within-patient increase), and increased from 0.7 units/kg to 1.3 units/kg (a 181% within-patient increase) in the placebo group, over the same gestational period (P=.002). Serial hemoglobin A1c levels were lower in the aspirin group than in the placebo group, although this trend did not reach statistical significance.CONCLUSIONIn this multicenter, double-blinded, placebo-controlled randomized trial, aspirin did not reduce the risk of adverse perinatal outcome in pregnancies complicated by prepregnancy diabetes mellitus. Compared with the placebo group, aspirin-treated patients required significantly less insulin throughout pregnancy, indicating a beneficial effect of aspirin on glycemic control. Aspirin may exert a plausible placenta-mediated effect on pregestational diabetes mellitus that is not limited to its antithrombotic properties.

(Abstracted from JAMA 2023;330(16):1547–1556 Worldwide, about 2.93 million pregnancies are complicated by gestational diabetes mellitus (GDM) annually. GDM is associated with an increased risk of maternal adverse outcomes, such as weight gain, cesarean delivery (CD), and preeclampsia, as well as fetal adverse outcomes, such as admission to the neonatal intensive care unit (NICU) due to birth injuries and respiratory disease.

Importance:Gestational diabetes is a common complication of pregnancy and the optimal management is uncertain.Objective:To test whether early initiation of metformin reduces insulin initiation or improves fasting hyperglycemia at gestation weeks 32 or 38.Design, Setting, and Participants:Double-blind, placebo-controlled trial conducted in 2 centers in Ireland (one tertiary hospital and one smaller regional hospital). Participants were enrolled from June 2017 through September 2022 and followed up until 12 weeks' postpartum. Participants comprised 510 individuals (535 pregnancies) diagnosed with gestational diabetes based on World Health Organization 2013 criteria.Interventions:Randomized 1:1 to either placebo or metformin (maximum dose, 2500 mg) in addition to usual care.Main Outcomes And Measures:The primary outcome was a composite of insulin initiation or a fasting glucose level of 5.1 mmol/L or greater at gestation weeks 32 or 38.Results:Among 510 participants (mean age, 34.3 years), 535 pregnancies were randomized. The primary composite outcome was not significantly different between groups and occurred in 150 pregnancies (56.8%) in the metformin group and 167 pregnancies (63.7%) in the placebo group (between-group difference, -6.9% [95% CI, -15.1% to 1.4%]; relative risk, 0.89 [95% CI, 0.78-1.02]; P = .13). Of 6 prespecified secondary maternal outcomes, 3 favored the metformin group, including time to insulin initiation, self-reported capillary glycemic control, and gestational weight gain. Secondary neonatal outcomes differed by group, with smaller neonates (lower mean birth weights, a lower proportion weighing >4 kg, a lower proportion in the >90% percentile, and smaller crown-heel length) in the metformin group without differences in neonatal intensive care needs, respiratory distress requiring respiratory support, jaundice requiring phototherapy, major congenital anomalies, neonatal hypoglycemia, or proportion with 5-minute Apgar scores less than 7.Conclusion and relevance:Early treatment with metformin was not superior to placebo for the composite primary outcome. Prespecified secondary outcome data support further investigation of metformin in larger clinical trials.Trial Registration:ClinicalTrials.gov Identifier: NCT02980276; EudraCT: 2016-001644-19.

ImportanceGestational diabetes is a common complication of pregnancy and the optimal management is uncertain.ObjectiveTo test whether early initiation of metformin reduces insulin initiation or improves fasting hyperglycemia at gestation weeks 32 or 38.Design, Setting, and ParticipantsDouble-blind, placebo-controlled trial conducted in 2 centers in Ireland (one tertiary hospital and one smaller regional hospital). Participants were enrolled from June 2017 through September 2022 and followed up until 12 weeks’ postpartum. Participants comprised 510 individuals (535 pregnancies) diagnosed with gestational diabetes based on World Health Organization 2013 criteria.InterventionsRandomized 1:1 to either placebo or metformin (maximum dose, 2500 mg) in addition to usual care.Main Outcomes And MeasuresThe primary outcome was a composite of insulin initiation or a fasting glucose level of 5.1 mmol/L or greater at gestation weeks 32 or 38.ResultsAmong 510 participants (mean age, 34.3 years), 535 pregnancies were randomized. The primary composite outcome was not significantly different between groups and occurred in 150 pregnancies (56.8%) in the metformin group and 167 pregnancies (63.7%) in the placebo group (between-group difference, −6.9% [95% CI, −15.1% to 1.4%]; relative risk, 0.89 [95% CI, 0.78-1.02]; P = .13). Of 6 prespecified secondary maternal outcomes, 3 favored the metformin group, including time to insulin initiation, self-reported capillary glycemic control, and gestational weight gain. Secondary neonatal outcomes differed by group, with smaller neonates (lower mean birth weights, a lower proportion weighing >4 kg, a lower proportion in the >90% percentile, and smaller crown-heel length) in the metformin group without differences in neonatal intensive care needs, respiratory distress requiring respiratory support, jaundice requiring phototherapy, major congenital anomalies, neonatal hypoglycemia, or proportion with 5-minute Apgar scores less than 7.Conclusion and relevanceEarly treatment with metformin was not superior to placebo for the composite primary outcome. Prespecified secondary outcome data support further investigation of metformin in larger clinical trials.Trial RegistrationClinicalTrials.gov Identifier: NCT02980276; EudraCT: 2016-001644-19

Background Pregnancy induces physiological changes which affect biochemical and haematological parameters. As the significance of laboratory test results change throughout pregnancy, the reference interval (RI) or key result interpretive guide should be specific to pregnancy. This study sought to establish trimester-specific-RIs for routine biochemical and haematological tests in healthy white European women with singleton pregnancies with comparison to RIs for non-pregnant European adults. Methods A retrospective analysis of a prospective longitudinal single-centre study of healthy pregnant women conducted between November 2018 and December 2020 in a tertiary academic hospital with approximately 3000 births annually. Inclusion criteria: signed informed consent, age ≥18 years, white European, body mass index (BMI) <25 kg/m2, blood pressure <140/90mmHg, non-smoker, no previous pathology or gestational diabetes. Trimester defined as T1: up to 13 weeks + 6 days, T2: 14–27 weeks + 6 days and T3: ≥28–41 weeks + 6 days. Baseline demographics, anthropometric and laboratory measurements were recorded. In total, 31 biochemical and 10 haematological ISO15189:2012 accredited tests were measured using Roche Cobas® and Sysmex XN-9100™ analysers, respectively. RIs were established according to the International Federation of Clinical Chemistry (IFCC) recommended method. Results Apparently healthy pregnant women ( n = 124) with bio-banked serum samples in each trimester were recruited. At the booking visit, 49.2% ( n = 61) of participants were nulliparous, with median age of 34.4 (IQR: 31.3–37.3) years, gestational age of 89 (IQR: 84–93) days, BMI of 22.5 (IQR: 21.0–23.7) kg/m2 and systolic and diastolic blood pressure of 116 (110–125) mmHg and 67 (61–75) mmHg, respectively. Conclusions Normative trimester-specific biological intervals for routinely requested biochemical and haematological medical laboratory tests were established. These RIs will be invaluable to result interpretation and the management of pregnant women.

Background Cardiotocography (CTG) is a screening test used to detect fetal hypoxia in labour. It has a high false positive rate resulting in many potentially unnecessary caesarean sections. Fetal blood sampling (FBS) is a second-line test of the acid-base status of the fetus. It is used to provide either reassurance that it is safe for labour to continue or objective evidence of compromise so that delivery can be expedited. Digital fetal scalp stimulation (dFSS) to elicit a fetal heart rate acceleration is an alternative less invasive second-line test of fetal wellbeing. This study aims to provide robust evidence on the role of these two second-line tests in assessing fetal wellbeing and potentially preventing operative delivery. Methods A multi-centre parallel group randomised controlled trial (RCT) is planned in four maternity centres in Ireland. The study aims to recruit 2500 nulliparous women with a term (≥37+0 weeks) singleton pregnancy who require a second-line test of fetal wellbeing in labour due to an abnormal CTG. Women will be allocated randomly to dFSS or FBS on a 1:1 ratio. The primary outcome is caesarean section. With 1250 women in each arm, the study will have 90% power to detect a difference of 5–6%, at a two-sided alpha significance level of 5%, assuming a caesarean section rate of at least 20% in the dFSS group. Discussion If the proposed study shows evidence that dFSS is a safe, reliable and effective alternative to FBS, this would have ground-breaking implications for labour management worldwide. It could potentially lead to a reduction in invasive procedures and emergency caesarean sections. Trial registration ClinicalTrials.gov NCT05306756. Registered on 31 March 2022. The trial commenced enrolment on 10 May 2022. Ethical committee approval has been granted by the Research Ethics Committee (REC) of each hospital: Dublin/CWIUH REC: 12.06.2019; Cork/UCC REC: 29.11.2019; Galway/NUIG REC: 06.09.2019; Limerick/UL REC: 30.09.2019.

INTRODUCTION AND AIMS Objective structured clinical examinations (OSCEs) play a pivotal role in medical education assessment. The Advanced Clinical Skills (ACS) OSCE examines clinical skills in psychiatry, general practice, obstetrics and gynaecology and paediatrics. This study examined if the 2020 ACS OSCE for fourth year medical students attending the National University of Ireland, Galway, was associated with any significant result differences compared to the equivalent 2019 OSCE. Additionally, we assessed students' satisfaction and explored any organisational difficulties in conducting a face-to-face OSCE during the COVID-19 pandemic. MATERIALS AND METHODS This study compared anonymised data between the 2019 and 2020 ACS OSCEs and analysed anonymised student feedback pertaining to the modified 2020 OSCE. RESULTS The mean total ACS OSCE result achieved in 2020 was statistically higher compared to the 2019 OSCE [62.95% (SD = 6.21) v. 59.35% (SD = 5.54), t = 6.092, p < 0.01], with higher marks noted in psychiatry (p = 0.001), paediatrics (p = 0.001) and general practice (p < 0.001) with more students attaining honours grades (χ2 = 27.257, df = 3, p < 0.001). No difference in failure rates were found. Students reported feeling safe performing the 2020 OSCE (89.2%), but some expressed face-mask wearing impeded their communication skills (47.8%). CONCLUSION This study demonstrates that conducting a face-to-face OSCE during the pandemic is feasible and associated with positive student feedback. Exam validity has been demonstrated as there was no difference in the overall pass rate.

Summary Background Gestational diabetes mellitus (GDM) is associated+ with adverse pregnancy outcomes compared with women with normal glucose tolerance in pregnancy. The WHO recommends screening at 24–28 weeks gestation for GDM. Women who are diagnosed before 24–28 weeks gestation have a longer intervention period which may impact positively on pregnancy outcomes. Aim This study aimed to examine pregnancy outcomes of women with GDM diagnosed <24 weeks gestation compared with those diagnosed at 24–28 weeks in a large Irish cohort. Methods A retrospective cohort study of 1471 pregnancies in women with GDM diagnosed using IADPSG criteria between September 2012 and April 2016 was conducted. At GDM diagnosis, women were classified as early GDM <24 weeks or standard GDM 24–28 weeks gestation. Results Women with early GDM had a significantly greater risk of pregnancy-induced hypertension (12.4% vs. 5.3%; P < 0.05), post-partum haemorrhage (8.7% vs. 2.4%; P < 0.05) and post-partum glucose abnormalities (32% vs. 15.6%; P < 0.05). Their offspring had a greater risk of pre-maturity (10.9% vs. 6.6%; P < 0.05), stillbirth (1.4% vs. 0.5%; P < 0.05), large for gestational age (19.1% vs. 13.4% P < 0.05) and need neonatal intensive care (30.7% vs. 22.1%; P < 0.05) compared with offspring of women with standard GDM. Rates of C-section and pre-maturity were still higher in the early GDM group when the two groups where compared based on their post-natal OGTT. Conclusion Early GDM women and their offspring are at greater risk of an adverse pregnancy outcome compared with those diagnosed at 24–28 weeks. In view of the abnormal post-natal glucose findings, early GDM may reflect a more advanced state in diabetes pathogenesis.

BACKGROUND:Preeclampsia, preterm birth and low birth weight represent key contributing factors to perinatal morbidity and mortality. Pregnancies complicated by type 1 and type 2 diabetes are at increased risk of these complications, which are purported to be largely attributed to placental dysfunction. Studies investigating a potential role for aspirin therapy in optimizing perinatal outcome have consistently failed to demonstrate a benefit among women with pre-existing diabetes, and yet widespread aspirin administration has become common practice in many centres. This study seeks to examine the effect of aspirin therapy, administered from the first trimester until 36 weeks gestation, on perinatal outcome in women with established pre-pregnancy diabetes. Our hypothesis is that aspirin therapy will reduce complications mediated by placental dysfunction, and improve perinatal outcomes.METHODS:This phase III double-blinded, placebo-controlled randomized clinical trial will be conducted in seven tertiary-level perinatology centres in Ireland. Consenting participants who meet all eligibility criteria will be allocated randomly to either aspirin 150 mg once daily or matching placebo, commenced between 11 + 0 and 13 + 6 weeks. Allocation will take place electronically using software by Clininfo with randomization tables provided by the trial biostatistician. The primary outcome will be a composite clinical measure of placental dysfunction (preeclampsia, preterm birth before 34 weeks, birthweight below the 10th centile or perinatal mortality). This trial has been set up such that it is parallel in design and is a superiority study. No participants have been recruited yet. The trial has been registered with Eudra Clinical Trials - EudraCT Number 2018-000770-29. Funding for this trial was granted by the Health research Board (HRB) 1/9/2017(DIFA-2017-026).DISCUSSION:Aspirin therapy has been investigated for the prevention of preeclampsia owing to its reduction on thromboxane production. Previous studies have failed to demonstrate a beneficial effect of aspirin on perinatal outcome amongst women with type I or type II diabetes. It is plausible that the failure to observe benefit to date, among the limited aspirin studies that have included participants with diabetes, may be a consequence of aspirin initiation too late in pregnancy to exert any effect on placentation. We believe that if aspirin is to be used for the prevention of placental dysfunction, it must be initiated before the second active phase of trophoblast invasion, which takes place from 14 weeks' gestation onwards. No randomized trials investigating the role of aspirin in prevention of preeclampsia in pregnancies complicated by diabetes have previously initiated treatment in the first trimester, the gestational period at which it is most likely to exert an effect on placentation.