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The significance of increasing rates of gestational diabetes mellitus (GDM) is confronting healthcare systems. The advent of telemedicine provides an opportunity to alleviate this pressure. We sought to evaluate the impact of a tailored smartphone app-assisted care pathway (‘GDMapp’) designed for personalised self-management for patients with newly diagnosed GDM. Women with GDM, commencing a trial of medical nutrition and lifestyle therapy, were approached for consideration for enrolment. Glycaemic, maternal, perinatal, and neonatal outcomes were compared between the app-using group and matched historical controls. Data variables were summarised using univariable descriptive statistics. The groups were compared using statistical hypothesis testing. ‘GDMapp’ was used by 168 participants. Outcomes were measured against a historical control group of 162 prospectively recruited patients receiving standard GDM care. Patients using the app had lower overall glycaemic indices across both fasting ( p  = 0.022) and postprandial ( p  < 0.001) parameters. Overall, app-users had fewer instances of above threshold glycaemic control. Adjunctive use of app- based care demonstrated non-inferiority for adverse maternal, birth and neonatal outcomes. This app-assisted model of care for GDM safely facilitates self-management and remote monitoring of GDM. The improved postprandial glycaemic control among app-users reflects the benefit of the in-app educational, motivational, and self-management tools.

AbstractObjectiveTo determine whether the addition of placental growth factor (PlGF) measurement to current clinical assessment of women with suspected pre-eclampsia before 37 weeks' gestation would reduce maternal morbidity without increasing neonatal morbidity.DesignStepped wedge cluster randomised control trial from 29 June 2017 to 26 April 2019.SettingNational multisite trial in seven maternity hospitals throughout the island of IrelandParticipantsWomen with a singleton pregnancy between 20+0 to 36+6 weeks’ gestation, with signs or symptoms suggestive of evolving pre-eclampsia. Of the 5718 women screened, 2583 were eligible and 2313 elected to participate.InterventionParticipants were assigned randomly to either usual care or to usual care plus the addition of point-of-care PlGF testing based on the randomisation status of their maternity hospital at the time point of enrolment.Main outcomes measuresCo-primary outcomes of composite maternal morbidity and composite neonatal morbidity. Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects (with robust standard errors) by intention-to-treat.ResultsOf the 4000 anticipated recruitment target, 2313 eligible participants (57%) were enrolled, of whom 2219 (96%) were included in the primary analysis. Of these, 1202 (54%) participants were assigned to the usual care group, and 1017 (46%) were assigned the intervention of additional point-of-care PlGF testing. The results demonstrate that the integration of point-of-care PlGF testing resulted in no evidence of a difference in maternal morbidity—457/1202 (38%) of women in the control group versus 330/1017 (32%) of women in the intervention group (adjusted risk ratio (RR) 1.01 (95% CI 0.76 to 1.36), P=0.92)—or in neonatal morbidity—527/1202 (43%) of neonates in the control group versus 484/1017 (47%) in the intervention group (adjusted RR 1.03 (0.89 to 1.21), P=0.67).ConclusionsThis was a pragmatic evaluation of an interventional diagnostic test, conducted nationally across multiple sites. These results do not support the incorporation of PlGF testing into routine clinical investigations for women presenting with suspected preterm pre-eclampsia, but nor do they exclude its potential benefit.Trial registrationClinicalTrials.gov NCT02881073.

The recommended mode of delivery for the fetus with an abdominal wall defect is controversial, with no evidence to support caesarean delivery other than for routine obstetric indications. We sought to review mode of delivery in cases of prenatally diagnosed gastrochisis in our centre. This was a retrospective cohort study of prenatally diagnosed fetal gastroschisis cases in the Rotunda Hospital over a fourteen year period. Cases were identified from the Fetal Assessment Unit database. We identified 35 cases fetal gastroschisis cases during the study period. The average age of mothers was 22.5 years. The median gestation at delivery was 35 + 4 with an average birthweight of 1.97 kg. An elective caesarean section was performed in 13.3% (n = 4) cases. Vaginal delivery was the intended mode of delivery for the remaining cases (n = 26) however 54% resulted in an emergency caesarean delivery with nonreassuring CTG cited as the most common indication (64%, 9/14). Of these, 50% (7/14) were performed outside of normal working hours. Although the numbers in our cohort are relatively small, we found a significantly high rate of caearean delivery in young women with pregnancies complicated by gastroschisis. The high proportion of cases with nonreassuring fetal testing during labour resulted in a higher than expected number of emergency deliveries which were performed outside normal working hours. Our findings suggest that re-evaluation of the optimal mode of delivery in this cohort may be warranted.

Objective To evaluate the significance of an abnormal cerebroplacental ratio (CPR) in twin pregnancies. Study design In the prospective multicenter ESPRiT study, twin pregnancies underwent serial sonographic evaluation including multi-vessel Doppler studies. CPR was expressed as the ratio of the pulsatility index (PI) of the middle cerebral artery to the PI of the umbilical artery. CPR PI < 1.0 was considered abnormal. The relationship between abnormal CPR at final sonographic examination and adverse clinical outcomes was assessed and results stratified by chorionicity. A p-value of <0.01 was considered significant. Results Of 1028 twin pairs recruited, 932 had CPR data available. 18% of the cohort were monochorionic (MC), of whom 15.2% had an abnormal CPR at the final sonographic evaluation. This was not significantly different among dichorionic (DC) twins (12.7%; p = 0.24 for comparison). In MC twins an abnormal CPR did not predict adverse clinical outcomes. In contrast, among DC twins an abnormal CPR prior to delivery was associated with reduced mean birthweight (BW) (p = 0.0002) and an increase in the rates of BW <5th centile (p = 0.01), NICU admission (p = 0.001) and perinatal morbidity (p = 0.002). There was also a trend toward a lower mean GA at delivery and higher rates of both preterm delivery and significant inter-twin BW discordance. Conclusion An abnormal CPR is strongly associated with adverse outcomes in DC twin pregnancies but not in MC twin pregnancies. This reflects the differing pathological processes, which affect growth and placental function in DC and MC pregnancies.

We sought to evaluate the outcomes in a cohort of MCDA twins with a diagnosis of selective intra-uterine growth restriction (sIUGR) who were managed expectantly. This prospective multicenter cohort study recruited 1,028 unselected twin pairs over 2 years in Ireland. Monochorionic twins underwent fortnightly ultrasonographic surveillance from 16 weeks. The defining criterion for sIUGR was an estimated fetal weight less than the 10th centile in one twin with an appropriately grown co-twin. Details of the prenatal course, delivery timing and perinatal outcomes were recorded. Outcome data were recorded for 100% of the 1,001 twin pairs that completed the study (n = 200 monochorionic). Five percent (n = 10) of the MCDA twin pregnancies were diagnosed with sIUGR at a median gestation of 30 weeks (range 26 – 35 weeks). AEDF or REDF was identified in two of these cases. The median time interval from diagnosis to delivery was 36.8 days (range 3 – 66 days) at a mean gestation of 34.2 weeks (range 26 – 37.9 weeks). 70% of the affected twins were admitted to the NICU with a mean stay of 19 days. There were no perinatal mortalities recorded. Our findings demonstrated excellent outcomes for our cohort of MCDA twins complicated by selective IUGR. There was no single IUFD and in turn there was no morbidity conferred to the appropriately grown co-twin. Close surveillance with regular ultrasonography and Doppler evaluation was essential and allowed continuation of the majority affected pregnancies to a late gestational age, thereby optimising outcome for both twins.

Aim To identify the incidence of monochorionic monoamniotic (MCMA) twins over a 5 year period in a tertiary referral centre and to assess the perinatal outcome this group. Methods A retrospective search of ultrasound database of both electronic and paper records was performed from October 2006-October 2011. All pregnancies >12 weeks were included. Chorionicity was confirmed by histological review of placentae. Results 359 monochorionic pregnancies were identified, 6.4% (24) were MCMA. There were 2 TRAP sequences, 2 conjoined twin pairs, 2 MCMA pairs within triplet pregnancies, 2 twin pairs with congenital anomalies. 14/24 (61%) had USS evidence of cord entanglement. Excluding conjoined twins, TRAP and triplets, there were 18 simple MCMA pairs with a loss rate after 12 weeks of 14/36 (38%), excluding congenital anomalies this was 31%. Double demise was more common. After 20 weeks, there were 4/24 IUD (15%) and after 24 weeks there were no IUDs. Maternal age range was 17-34 years,( mean 27). The mean infant birthweight was 1824g. Length of stay in NICU ranged from 3-18 days ( mean 8.3). The only neonatal death was an infant with a prenatally diagnosed congenital anomaly. The mean gestational age at delivery was 32 weeks for the liveborn twin pairs, with a 100% caesarean section rate. Conclusion Perinatal mortality is mainly a consequence of conjoined twins, TRAP, congenital anomalies and miscarriage less than 20 weeks gestation. Perinatal survival in MCMA twins managed by close ultrasound surveillance and elective delivery at 32-34 weeks is high.

The use of oxytocin for induction and augmentation of labour is a major component in the active management of labour. Its use is associated with lower caesarean section rates however it carries potential for uterine hyperstimulation/tachysystole and fetal compromise. We sought to compare the standard ‘high-dose’ regimen employed in the Rotunda hospital until July2010 with a lower dose regimen. The regimen of oxytocin for induction/augmentation of primigravid labour changed on 1/07/2010 to a ‘low-dose’ regimen commonly employed internationally. We prospectively recorded maternal characteristics and perinatal outcomes among primiparous women exposed to the'low-dose' regimen (September2010) and those exposed to the high-dose regimen in June2010. 116 primiparous women received the high-dose oxytocin regimen. 143 women received the low-dose regimen. Maternal characteristics (maternal age, gestation or induced labour rates) were similar in the two cohorts. There was no significant difference in duration of the 1st stage of labour. A decreased incidence of uterine hyperstimulation was observed in women exposed to the low-dose regimen (8.4vs46.6%, p<0.0001). The low-dose regimen was also associated with a statistically significant reduction in the duration of the second stage of labour. Although a trend was observed toward an increased caesarean delivery rate with the lower dose regimen, this did not achieve statistical significance (20.3vs16.4%, p=0.4218). Rates of NICU admission, instrumental delivery or anal sphincter injury were similar in both groups. Our findings suggest a low-dose oxytocin regimen is associated with decreased uterine hyperstimulation and decreased duration of the second stage of labour. Mode of delivery and perinatal outcome were unaffected.

2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022. 37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75–1·07; p=0·23). The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven. Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

Background The Cancer Genome Atlas analysis revealed that somatic EGFR , receptor tyrosine-protein kinase erbB-2 ( ERBB2 ), Erb-B2 receptor tyrosine kinase 3 ( ERBB3 ) and Erb-B2 receptor tyrosine kinase 4 ( ERBB4 ) gene mutations (ERBB family mutations) occur alone or co-occur with somatic mutations in the gene encoding the phosphatidylinositol 3-kinase (PI3K) catalytic subunit ( PIK3CA ) in 19% of human epidermal growth factor receptor 2 (HER2)-positive breast cancers. Because ERBB family mutations can activate the PI3K/AKT pathway and likely have similar canonical signalling effects to PI3K pathway mutations, we investigated their combined impact on response to neoadjuvant HER2-targeted therapies. Methods Baseline tumour biopsies were available from 74 patients with HER2-positive breast cancer who were enrolled in the phase II TCHL neoadjuvant study (ICORG 10-05) assessing TCH (docetaxel, carboplatin, trastuzumab) ( n  = 38) versus TCL (docetaxel, carboplatin, lapatinib) ( n  = 10) versus TCHL (docetaxel, carboplatin, trastuzumab, lapatinib) ( n  = 40), each for six cycles. Activating mutations in PIK3CA and ERBB family genes were identified using mass spectrometry-based genotyping. Phosphatase and tensin homolog (PTEN) expression was assessed by immunohistochemistry. Results PIK3CA and/or ERBB family mutations were detected in 23 (31.1%) tumour samples tested, whereas PTEN expression was low in 31.1% of cases tested. Mutation frequency was similar in each treatment arm (31.3% in TCH arm, 30% in TCL arm and 31.3% in TCHL arm) and was not influenced by oestrogen receptor (ER) status (27.6% in ER-negative patients, 33.3% in ER-positive patients) or progesterone receptor (PR) status (32.6% in PR-negative patients, 29% in PR-positive patients). There was no significant difference in pathological complete response (pCR) rates between 47 patients with wild-type (WT) tumours and 22 patients whose tumours carried mutations (in either PIK3CA or ERBB family genes) (42.5% vs. 54.5%; p  = 0.439). Similarly, there was no significant difference in pCR rates between patients with PIK3CA/ERBB family mutated/PTEN-low (i.e., PI3K-activated) tumours and patients without PI3K activation (50% vs. 44%; p  = 0.769). However, in the TCHL (but not the TCH) group, the pCR rate was higher for 9 patients with PIK3CA/ERBB family mutated tumours than for 20 patients with PIK3CA/ERBB family WT tumours (77.8% vs. 35%; p  = 0.05). Conclusions Our results indicate that patients who receive neoadjuvant TCHL and have PIK3CA/ERBB family mutated tumours may be more likely to have a pCR than patients with WT tumours. Trial registration ClinicalTrials.gov, NCT01485926 . Registered on 2 December 2011.

ObjectiveEvaluate the feasibility and acceptability of routine aspirin in low-risk women, compared with screening-test indicated aspirin for the prevention of pre-eclampsia and fetal growth restriction.DesignMulticentre open-label feasibility randomised controlled trial.SettingTwo tertiary maternity hospitals in Dublin, Ireland.Participants546 low-risk nulliparous women completed the study.InterventionsWomen underwent computerised randomisation to: Group 1—routine aspirin 75 mg from 11 until 36 weeks; Group 2—no aspirin and; Group 3—aspirin based on the Fetal Medicine Foundation screening test.Primary and secondary outcome measures(1) Proportion agreeing to participate; (2) compliance with protocol; (3) proportion where first trimester uterine artery Doppler was obtainable and; (4) time taken to issue a screening result. Secondary outcomes included rates of pre-eclampsia and small-for-gestational-age fetuses.Results546 were included in the routine aspirin (n=179), no aspirin (n=183) and screen and treat (n=184) groups. 546 of 1054 were approached (51.8%) and enrolled. Average aspirin adherence was 90%. The uterine artery Doppler was obtained in 98.4% (181/184) and the average time to obtain a screening result was 7.6 (0–26) days. Of those taking aspirin, vaginal spotting was greater; n=29 (15.1%), non-aspirin n=28 (7.9%), OR 2.1 (95% CI 1.2 to 3.6). Postpartum haemorrhage >500 mL was also greater; aspirin n=26 (13.5%), no aspirin n=20 (5.6%), OR 2.6 (95% CI 1.4 to 4.8).ConclusionLow-risk nulliparous women are open to taking aspirin in pregnancy and had high levels of adherence. Aspirin use was associated with greater rates of vaginal bleeding. An appropriately powered randomised controlled trial is now required to address the efficacy and safety of universal low-dose aspirin in low-risk pregnancy compared with a screening approach.Trial registration numberISRCTN (15191778); Post-results.