Digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS) to assess fetal wellbeing in labour-a multi-centre randomised controlled trial: Fetal Intrapartum Randomised Scalp Stimulation Trial (FIRSST NCT05306756).

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.

Undertaking a face-to-face objective structured clinical examination for medical students during the COVID-19 pandemic.

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.

Early gestational diabetes mellitus (GDM) is associated with worse pregnancy outcomes compared with GDM diagnosed at 24-28 weeks gestation despite early treatment.

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.

Placental prothrombin mRNA levels in APC resistance (APCR) women with increased placental fibrin deposition.

We investigated the link between the mRNA of the procoagulant prothrombin in the placental tissue with the increased placental fibrin deposition associated with activated protein C resistance (APCR). Women with APCR were not found to produce higher levels of prothrombin transcript compared to women with a normal APC ratio. This indicates that accumulated fibrin in the placenta is not the consequence of too much production of the procoagulant prothrombin transcript, but may be associated with altered function of other haemostatic factors interacting with APC in the placenta.

Concealed pregnancy: prevalence, perinatal measures and socio-demographics.

A target group of women who concealed their pregnancy (n = 43) was compared to an aged-matched control group (n = 30) that experienced a crisis pregnancy. Comparisons were also made with a larger dataset (n = 6363) of births in University Hospital Galway (UHG) (normative group). Data was analysed using the Chi-square test and the Kolmogorov-Smirnoff two-sample test. The number of women from the target group that were from a rural background was 28 (65%), compared to 10 (33%) from the control group. The number of women from the target group that feared a negative parental reaction to the pregnancy was 34 (79%), compared to 12 (40%) from the control group. The birth weight in the target group was 4009 lower than the normative birth weight. The average age of women who concealed was 8 years lower than the normative age. The prevalence of concealed pregnancy in UHG was one in every 148 births.

ATLANTIC DIP: pregnancy outcomes for women with type 1 and type 2 diabetes.

ATLANTIC DIP prospectively evaluated the perinatal and maternal outcomes of pregnancies complicated by Type 1 and Type 2 diabetes during 2006/2007 in 5 antenatal centres. All women with established diabetes for at least 6 months prior to the index pregnancy and booking for antenatal care between 1/1/2006 and 31/12/2007 were included in the study. Results were collected electronically via the DIAMOND Diabetes Information System. Pregnancy outcome was compared with that of the background population receiving antenatal care in the region during the same time. There were 104 singleton pregnancies during the period of study. The stillbirth rate (SBR) of 25/1000 was 5 times greater than that reported in the background population at 5/1000 and the perinatal mortality rate (PMR) of 25/1000 was 3.5 times greater than background 7/1000. The congenital malformation rate (CMR) of 24/1000 was twice that observed in the background population. Women were not well prepared for pregnancy with 28% receiving pre pregnancy care (PPC), 43% receiving pre pregnancy folic acid and 51% achieving a HbA1C < = 7% at first antenatal visit. Pregnancy induced hypertension (PIH) and/or pre eclampsia toxaemia (PET) were three times more common than in women in the background population. In conclusion women are not well prepared for pregnancy. Maternal and infant morbidity and infant mortality are greater in women with diabetes. A regional pre pregnancy care (PPC) programme and centralised glucose management are urgently needed.

Atlantic DIP: the prevalence and consequences of gestational diabetes in Ireland.

ATLANTIC DIP carried out a universal screening programme for gestational diabetes mellitus (GDM) along the Irish Atlantic seaboard. Using a 75g OGTT and new International Association of Diabetes in Pregnancy Study Groups (IADPSG) cut off points for diagnosis we found the prevalence of GDM to be 12.4%. Pregnancies complicated by GDM displayed increased morbidities for mother and infant when compared to women who had normal glucose tolerance. With rising obesity levels and older age of mothers, both risk factors for GDM, these results would support a national universal screening programme.

Atlantic Diabetes in Pregnancy (DIP): the prevalence and outcomes of gestational diabetes mellitus using new diagnostic criteria.

AIMS/HYPOTHESIS: New diagnostic criteria for gestational diabetes mellitus (GDM) have recently been published. We wished to evaluate what impact these new criteria would have on GDM prevalence and outcomes in a predominantly European population. METHODS: The Atlantic Diabetes In Pregnancy (DIP) programme performed screening for GDM in 5,500 women with an oral glucose tolerance test at 24-28 weeks. GDM was defined according to the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria and compared with previous WHO criteria; maternal and neonatal adverse outcomes were prospectively recorded. RESULTS: Of the participants, 12.4% and 9.4% were diagnosed with GDM using IADPSG and WHO criteria, respectively. IADPSG GDM pregnancies were associated with a statistically significant increased incidence of adverse maternal outcomes (gestational hypertension, polyhydramnios and Caesarean section) and neonatal outcomes (prematurity, large for gestational age, neonatal unit admission, neonatal hypoglycaemia and respiratory distress). The odds ratio for the development of these adverse outcomes remained significant after adjustment for maternal age, body mass index and non-European ethnicity. Those women who were classified as having normal glucose tolerance by WHO criteria but as having GDM by IADPSG criteria also had significant adverse pregnancy outcomes. CONCLUSIONS/INTERPRETATION: GDM prevalence is higher when using newer IADPSG, compared with WHO, criteria, and these women and their offspring experience significant adverse pregnancy outcomes. Higher rates of GDM pose a challenge to healthcare systems, but improved screening provides an opportunity to attempt to reduce the associated morbidity for mother and child.

Successful pregnancy after simultaneous pancreas-kidney transplantation.

The effect of pregnancy on simultaneous pancreas-kidney transplant recipients has previously been described, but experience is limited. We describe the case of a thirty-five-year-old female who previously underwent simultaneous pancreas-kidney transplant for type 1 diabetes mellitus-complicated nephropathy. An integrated multidisciplinary team including the transplant team, nephrologist, endocrinologist, and obstetrician closely followed progress during pregnancy. Blood glucose levels and HbA1c remained within normal limits, and she did not require insulin treatment at any point. She experienced deterioration in renal indices and underwent an uncomplicated, elective Caesarean section at thirty-week gestation. She delivered a male infant of 1.18 kg, appropriate for gestational age, who had hypothermia and respiratory distress, which required intubation and ventilation and an eleven-week stay in the special care baby unit. At eighteen-month followup the infant shows normal development, and there has been no deterioration in either grafts' function.

Activated protein C resistance (APCR) and placental fibrin deposition.

Activated protein C resistance (APCR) results in an ineffective anticoagulant response leading to an increased risk of thrombosis, particularly during pregnancy. Adverse pregnancy outcomes including pre-eclampsia (PET), intrauterine growth restriction (IUGR), recurrent miscarriage and placental abruption have been linked with thrombotic lesions compromising the utero-placental circulation. Using histological staining including Martius Scarlet Blue (MSB) and Haematoxylin and Eosin (H&E) and microscopy, we studied placental fibrin deposition and histological abnormalities in subjects (n=23) with APCR (APCR group), based on a ratio of less than or equal to 2.1s with the Coatest classic test and subjects (n=11) with an APC ratio in the normal range, greater than 2.1s (APCN group). Fibrin deposition was significantly higher (3.3-fold) in the APCR group compared to the APCN group. An inverse correlation between APC ratio and placental fibrin deposition was determined for the study group. Histological abnormalities were more than 2-fold higher in the APCR group compared to the APCN group. Molecular screening identified common thrombophilic mutations, FVL and FII-G20210A in the APCR group but not in the APCN group.

Screening for haemoglobinopathy--a comparison of two methods in an Irish maternity unit.

Two-pronged retrospective and prospective studies were carried out to compare opportunistic versus systematic screening for carriers of haemoglobinopathy in an Irish maternity unit. Identification was either performed opportunistically on the basis of ethnicity or systematically on the basis of a low mean corpuscular haemoglobin. A comparison was made between the numbers that were tested for haemoglobinopathy and subsequent detection rates. In the prospective study women were identified again on the basis of either ethnicity or a low MCH and all women identified were tested for haemoglobin variants. A comparison was made between the numbers tested and subsequent detection rates. In both studies systematic screening identified similar rates as opportunistic screening. However, opportunistic screening identified a greater absolute number of carriers. Our retrospective study showed a disappointing uptake of testing of those identified, regardless of the method of screening. Better identification of carriers requires that all those identified as at-risk of haemoglobinopathy carriage should be tested, irrespective of the method of screening.

The usefulness of ultrasound assessment of amniotic fluid in predicting adverse outcome in prolonged pregnancy: a prospective blinded observational study.

OBJECTIVE: To determine whether a single ultrasound scan at or beyond 40 weeks of gestation to detect a single deepest pool of amniotic fluid <2 cm and amniotic fluid index (AFI) <5 cm is clinically useful in the prediction of subsequent adverse pregnancy outcome. DESIGN: A prospective double blind cohort study. SETTING: A university teaching hospital delivering approximately 6000 women annually. POPULATION: One thousand and five hundred and eighty-four pregnant women at or beyond 40 weeks of gestation. METHODS: Ultrasound assessment of liquor to detect the single deepest pool of amniotic fluid and derive the AFI at or after 40 weeks of gestation. MAIN OUTCOME MEASURES: Perinatal death, meconium aspiration, birth asphyxia, intervention in labour for fetal distress, a cord arterial pH <7 and admission to the neonatal unit. RESULTS: An AFI <5 cm but not a single deepest pool <2 cm was significantly associated with birth asphyxia or meconium aspiration. An AFI <5 cm was also significantly associated with caesarean section for fetal distress in labour, a cord arterial pH <7 at delivery and low Apgar scores. Despite there being a statistically significant association with adverse outcomes the sensitivity of AFI was low at 28.6%, 12% and 11.5% for major adverse outcome, fetal distress in labour or admission to the neonatal unit, respectively. CONCLUSIONS: The AFI is superior to a measure of the single deepest pool as an assessment of the fetus at or after 40 weeks but has a poor sensitivity for adverse pregnancy outcome. Routine use is likely to lead to increased obstetric intervention without improvement in perinatal outcomes.

Attitudes towards routine prenatal diagnostic investigations in obstetric practice in the Republic of Ireland.

The aim of this study was to evaluate the attitudes of pregnant women towards prenatal diagnosis in the Republic of Ireland. A questionnaire was administered to all women attending the antenatal clinic at University College Hospital, Galway between January and May 1999. 1042 women participated in the study and 1012 (97%) questionnaires were completed correctly. The majority of women, 763 (75.4%) and 748 (73.9%) respectively, would avail of a fetal anomaly scan or biochemical screening if available. However, confusion exists about the purpose of ultrasound scans currently available. The majority of respondents (71%) thought that the purpose of the currently available scan was to detect fetal abnormality. In reality, the primary purpose of the scan currently available is for other purposes and the detection of fetal abnormality is performed opportunistically rather than systematically. This confusion may reflect poor provision of information to our antenatal patients and should be addressed within by the obstetric service.

Children of parents with obsessive-compulsive disorder -- a 2-year follow-up study.

OBJECTIVE: To examine the association between parental obsessive-compulsive disorder (OCD) and emotional and behavioural disorders in offspring. METHOD: Demographic, clinical, and diagnostic data were collected from parents with OCD, control subjects, and their respective offspring. Offspring were reassessed at a 2-year follow-up. RESULTS: Probands with OCD and controls were relatively well matched for age, gender, race, educational rating, and marital status. Offspring of OCD probands were at greater risk than offspring of controls for dimensionally measured anxiety, depression, somatization, and social problems. OCD offspring were significantly more likely than control offspring to have lifetime overanxious disorder, separation anxiety disorder, OCD, or 'any anxiety disorder'. Female gender in the parent with OCD, evidence of family dysfunction, and high symptom levels in offspring were predictive of broadly defined OCD at follow-up. CONCLUSION: Children having a parent with OCD are more likely than control offspring to have social, emotional, and behavioural disorders.

Outcome at school age following antenatal detection of absent or reversed end diastolic flow velocity in the umbilical artery.

AIM: To determine whether fetal compromise, manifested by abnormalities of Doppler recordings of umbilical artery velocity waveforms in utero, is associated with neurodevelopmental or educational abnormalities at school age. METHODS: A cohort of neonates born following high risk pregnancies had been previously identified for a study of the perinatal sequelae of absent (AEDFV) and reversed (REDFV) end diastolic flow velocities. Seventy six children were assessed at 5-12 years of age by a developmental paediatrician who was blinded to perinatal course and Doppler assessments. Forty children born following pregnancies with forward end diastolic flow velocities (FEDFV), were compared with 27 with AEDFV and nine with REDFV. Tests of cognitive, neurological, and sensory function were performed, and reports of behavioural and educational progress were obtained from parents and teachers. RESULTS: There were no significant differences between FEDFV and AEDFV groups, but on tests of mental ability and neuromotor function the REDFV group had worse scores than either FEDFV or AEDFV. Comparing REDFV and FEDFV groups, the British Ability Scales general conceptual ability mean scores were 87.7 versus 101, and the Quick Neurological Screening Test mean scores were 32.8 versus 21.5. CONCLUSIONS: Absence of EDFV is well recognised as a marker of fetal compromise which is associated with acute perinatal sequelae. This study suggests it is not associated with adverse neurodevelopmental outcome. However, we found reversal of EDFV on antenatal assessment to be associated with a wide range of problems at school age, suggesting that REDFV represents intrauterine decompensation which may have adverse effects on the developing brain.

Severe HELLP syndrome remote from term.

A 27 year-old nulliparous woman was admitted to University College Hospital Galway with severe preeclampsia at 21 weeks 'gestation. In addition, there was evidence of HELLP syndrome with renal failure. A decision was made to end the pregnancy to save the mother's life. Labour was induced with misoprostol and vaginal delivery of a male stillborn fetus weighing 250 g was achieved after 19 hours. The condition of the patient improved gradually following delivery. Renal impairment, however, persisted postpartum. HELLP syndrome is a life-threatening complication of pregnancy which can only be cured by delivery. Other therapeutic modalities are only palliative but may improve the outcome for the very premature viable fetus. Conservative management is not an option when HELLP syndrome occurs long before fetal viability has been reached.

Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial.

OBJECTIVE: To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder (OCD) with a double-blind, placebo-controlled, multicenter study. METHOD: Subjects, aged 8 to 17 years, meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994. After a 7- to 14-day single-blind, placebo washout/screening period, subjects were randomly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks. Subjects who had not responded after 6 weeks could discontinue the double-blind phase of the study and enter a long-term, open-label trial of fluvoxamine. Analyses used an intent-to-treat sample with a last-observation-carried-forward method. RESULTS: Mean Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores with fluvoxamine were significantly (p < .05) different from those with placebo at weeks 1, 2, 3, 4, 6, and 10. Significant (p < .05) differences between fluvoxamine and placebo were observed for all secondary outcome measures at all visits. Based on a 25% reduction of CY-BOCS scores, 42% of subjects taking fluvoxamine were responders compared with 26% taking placebo. Forty-six (19 fluvoxamine, 27 placebo) of 120 randomized subjects discontinued early. Adverse events with a placebo-adjusted rate greater than 10% were insomnia and asthenia. CONCLUSIONS: Fluvoxamine has a rapid onset of action and is well tolerated and efficacious for the short-term treatment of pediatric OCD.