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AbstractObjectiveTo evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks.DesignMulticentre, open label, randomised controlled superiority trial.Setting14 hospitals in Sweden, 2016-18.Participants2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group.InterventionsInduction of labour at 41 weeks and expectant management and induction of labour at 42 weeks.Main outcome measuresThe primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat.ResultsThe study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups.ConclusionsThis study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths.Trial registrationCurrent Controlled Trials ISRCTN26113652.

AbstractObjectivesTo investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions.DesignPragmatic, multicentre, stepped wedge cluster randomised trial.Setting60 midwifery practices in the Netherlands.Participants13 046 women aged 16 years or older with a low risk singleton pregnancy.Interventions60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks’ gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies.Main outcome measuresThe primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth.ResultsBetween 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks’ gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies.ConclusionIn low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies.Trial registrationNetherlands Trial Register NTR4367.

In this randomized trial of treatment versus no treatment for mild gestational diabetes mellitus, rates of the primary outcome (a composite of stillbirth or perinatal death and neonatal hyperbilirubinemia, hypoglycemia, hyperinsulinemia, or birth trauma) did not differ significantly between groups. However, there were significant reductions with treatment in several secondary outcomes, including the frequency of large-for-gestational-age infants, shoulder dystocia, cesarean delivery, and hypertension in pregnancy. In this randomized trial of treatment versus no treatment for mild gestational diabetes mellitus, rates of the primary outcome (a composite of stillbirth or perinatal death and neonatal hyperbilirubinemia, hypoglycemia, hyperinsulinemia, or birth trauma) did not differ significantly between groups. However, there were significant reductions with treatment in several secondary outcomes. Gestational diabetes mellitus is defined as glucose intolerance that first occurs or is first identified during pregnancy. 1 The frequency of this condition is rising in the United States and occurs in 1 to 14% of all pregnancies, depending on varying characteristics of the population. 2 More than 40 years ago, O'Sullivan and Mahan developed glucose-tolerance-test criteria for the diagnosis of gestational diabetes mellitus. 3 The diagnostic thresholds that they developed were based on the subsequent development of adult-onset diabetes and were not predicated on any association between carbohydrate intolerance discovered during gestation and adverse pregnancy outcomes. Although gestational diabetes mellitus is a . . .

Abstract Context Gestational diabetes mellitus (GDM) diagnosed in early pregnancy is a health care challenge because it increases the risk of adverse outcomes. Plasma-glycated CD59 (pGCD59) is an emerging biomarker for diabetes and GDM. The aim of this study was to assess the performance of pGCD59 as a biomarker of early GDM and its association with delivering a large for gestational age (LGA) infant. Objectives To assess the performance of pGCD59 to identify women with GDM in early pregnancy (GDM < 20) and assess the association of pGCD59 with LGA and potentially others adverse neonatal outcomes linked to GDM. Methods Blood levels of pGCD59 were measured in samples from 693 obese women (body mass index > 29) undergoing a 75-g, 2-hour oral glucose tolerance test (OGTT) at <20 weeks’ gestation in the Vitamin D and Lifestyle Intervention study: the main analyses included 486 subjects who had normal glucose tolerance throughout the pregnancy, 207 who met criteria for GDM at <20 weeks, and 77 diagnosed with GDM at pregnancy weeks 24 through 28. Reference tests were 75-g, 2-hour OGTT adjudicated based on International Association of Diabetes and Pregnancy Study Group criteria. The index test was a pGCD59 ELISA. Results Mean pGCD59 levels were significantly higher (P < 0.001) in women with GDM < 20 (3.9 ± 1.1 standard peptide units [SPU]) than in those without (2.7 ± 0.7 SPU). pGCD59 accurately identified GDM in early pregnancy with an area under the curve receiver operating characteristic curves of 0.86 (95% confidence interval [CI], 0.83-0.90). One-unit increase in maternal pGCD59 level was associated with 36% increased odds of delivering an LGA infant (odds ratio for LGA vs non-LGA infant: 1.4; 95% CI, 1.1-1.8; P = 0.016). Conclusion Our results indicate that pGCD59 is a simple and accurate biomarker for detection of GDM in early pregnancy and risk assessment of LGA.

The National Neonatal Research Database (NNRD) is a rich repository of pre-defined clinical data extracted at regular intervals from point-of-care, clinician-entered electronic patient records on all admissions to National Health Service neonatal units in England, Wales, and Scotland. We describe population coverage for England and assess data completeness and accuracy. We determined population coverage of the NNRD in 2008-2014 through comparison with data on live births in England from the Office for National Statistics. We determined the completeness of seven data items on the NNRD. We assessed the accuracy of 44 data items (16 patient characteristics, 17 processes, 11 clinical outcomes) for infants enrolled in the multi-centre randomised controlled trial, Probiotics in Preterm Study (PiPs). We compared NNRD to PiPs data, the gold standard, and calculated discordancy rates using predefined criteria, and sensitivity, specificity and positive predictive values (PPV) of binary outcomes. The NNRD holds complete population data for England for infants born alive from 25+0 to 31+6 (completed weeks) of gestation; and 70% and 90% for those born at 23 and 24 weeks respectively. Completeness of patient characteristics was over 90%. Data were linked for 2257 episodes of care received by 1258 of the 1310 babies recruited to PiPs. Discordancy rates were <5% for 13/16 patient characteristics (exceptions: mode of delivery 8.7%; maternal ethnicity 10.2%, Lower layer Super Output Area 16.5%); <5% for 9/16 processes (exceptions: medical treatment for Patent ductus arteriosus 6.1%, high-dependency days 10.2%, central line days 11.2%, type of first milk 22.3%; and during first 14 days, summary of types of milk 13.8%; number of days of antibiotics 9.0%; whether antacid given 5.1%); and <5% for 10/11 clinical outcomes (exception: Bronchopulmonary dysplasia, defined as oxygen dependency at 36 weeks postmenstrual age 3.3%). The specificity of NNRD data was >85% for all outcomes; sensitivity ranged from 50-100%; PPV ranged from 58.8 (95% CI 40.8-75.4%) for porencephalic cyst to 99.7 (95% CI 99.2, 99.9%) for survival to discharge. The completeness and quality of data held in the NNRD is high, providing assurance in relation to use for multiple purposes, including national audit, health service evaluations, quality improvement, and research.

Group B Streptococcus (GBS) is a major cause of neonatal morbidity and mortality. Serbia has not fully implemented preventive measures against GBS neonatal diseases. Therefore, we aimed to assess the maternal GBS colonisation and invasive neonatal disease rate, to reveal the trends of antimicrobial resistance and serotype distribution of GBS from various patient groups. Randomly selected non-invasive (n = 991) and all invasive GBS (n = 80) collected throughout Serbia from 2015 to 2020 were tested for antimicrobial susceptibility, capsular typing, and hvgA detection. Overall, 877/5621 (15.6%) pregnant women were colonised with GBS. Invasive GBS infections incidence in infants (0.18/1000 live births) showed a decreasing trend (0.3 to 0.1/1000 live births). Type III was overrepresented in infants with invasive infections (n = 35, 58.3%), whereas type V predominated among colonised adults (n = 224, 25.5%) and those with noninvasive (n = 37, 32.5%) and invasive infections (n = 8, 40%). The hypervirulent clone III/ST17 was highly associated with invasive infections (n = 28, 35%), particularly late-onset disease (n = 9, 47.4%), showing an increase from 12.3 to 14.8%. The GBS resistance to erythromycin and clindamycin was 26.7% and 22.1%, respectively, with an upward trend. The emergence of the hypervirulent clone III/ST17 and the escalation in GBS resistance highlight an urgent need for continuous monitoring of GBS infections.

Introduction Our objective was to study the strength of the association between meconium‐stained amniotic fluid and severe morbidity among neonates of nulliparas with prolonged pregnancies. Material and methods This was a secondary analysis of the NOCETER randomized trial that took place between 2009 and 2012 in which 11 French maternity units included 1373 nulliparas at 41+0 weeks of gestation onwards with a single live fetus in cephalic presentation. This analysis excluded patients with a cesarean delivery before labor and those with bloody amniotic fluid or of unreported consistency. The principal end point was a composite criterion of severe neonatal morbidity (neonatal death, 5‐minute Apgar <7, convulsions in the first 24 h, meconium aspiration syndrome, mechanical ventilation ≥24 h, or neonatal intensive care unit admission for 5 days or more). The neonatal outcomes of pregnancies with thin or thick meconium‐stained amniotic fluid were compared with those with normal amniotic fluid. The association between the consistency of the amniotic fluid and neonatal morbidity was tested by univariate and then multivariate analysis adjusted for gestational age at birth, duration of labor, and country of birth. Results This study included 1274 patients: 803 (63%) in the group with normal amniotic fluid, 196 (15.4%) in the thin amniotic fluid group, and 275 (21.6%) in the thick amniotic fluid group. The neonates of patients with thick amniotic fluid had higher rates of neonatal morbidity than those of patients with normal amniotic fluid (7.3% vs. 2.2%; p < 0.001; adjusted relative risk [aRR] 3.3, 95% confidence interval [CI] 1.7–6.3), but those of patients with thin amniotic fluid did not (3.1% vs. 2.2%; p = 0.50; aRR 1.0, 95% CI, 0.4–2.7). Conclusions Among nulliparas at 41+0 weeks onwards, only thick meconium‐stained amniotic fluid is associated with a higher rate of severe neonatal morbidity. Among nulliparas at 41+0 weeks onwards, only thick meconium‐stained amniotic fluid is associated with a higher rate of severe neonatal morbidity.

Background Ventilator-associated pneumonia (VAP) is a serious health care- associated infection, resulting in high morbidity and mortality. It also prolongs hospital stay and drives up hospital costs. Measures employed in preventing ventilator- associated pneumonia in developing countries are rarely reported. In this study we tried to assess the efficacy of our designed “VAP prevention bundle” in reducing VAP rate in our neonatal intensive care unit (NICU). Method This prospective before-and-after study was conducted at university hospital NICU, all neonates who had mechanical ventilation for ≥ 48 h were eligible. VAP rates were evaluated before (phase-I) and after (phase-II) full implementation of comprehensive preventive measures specifically designed by our infection control team. Results Of 143 mechanically ventilated neonates, 73 patients developed VAP (51 %) throughout the study period (2500 mechanical ventilation days). The rate of VAP was significantly reduced from 67.8 % (42/62) corresponding to 36.4 VAP episodes/1000 mechanical ventilation days (MV days) in phase-I to 38.2 % (31/81) corresponding to 23 VAP/1000 MV days (RR 0.565, 95 % confidence interval 0.408-0.782, p = 0.0006) after VAP prevention bundle implementation (phase-II). Parallel significant reduction in MV days/case were documented in post-intervention period (21.50 ± 7.6 days in phase-I versus 10.36 ± 5.2 days in phase-II, p = 0.000). There were a trend toward reduction in NICU length of stay (23.9 ± 10.3 versus 22.8 ± 9.6 days, p = 0.56) and overall mortality (25 % versus 17.3 %, p = 0.215) between the two phases but didn’t reach statistical significance. The commonest micro-organisms isolated throughout the study were gram-negative bacteria (63/66, 95.5 %) particularly Klebsilla pneumonia (55/66, 83.4 %). Conclusion Implementation of multifaceted infection control bundle resulted in reduction of VAP rate, length of stay in our NICU.

In pregnant women with gestational diabetes, glyburide can be an alternative to insulin despite concerns about its transplacental transfer. However, transplacental transfer of glyburide is poorly quantified and the relationship between cord blood glyburide concentration and hypoglycemia has not been studied. Our objective was to quantify the transplacental transfer of glyburide at delivery and to study the association between the cord blood glyburide concentration and the risk of neonatal hypoglycemia in patients with gestational diabetes treated with glyburide. INDAO was a multicenter, noninferiority, randomized trial conducted between May 2012 and November 2016 in 914 women with singleton pregnancies and gestational diabetes. An ancillary study was conducted in the 87 patients of the Bicêtre University Hospital Center. The sample consisted of 46 patients with utilizable assays at delivery. The relationships between glyburide concentration and the time since the last intake of glyburide and between fetal glyburide concentration and neonatal hypoglycemia were modeled with linear or logistic regressions using fractional polynomials. There was placental transfer of glyburide at a fetal to maternal ratio of 62% (95% CI [50; 74]). Umbilical cord blood glyburide concentration decreased steeply after the last maternal glyburide intake. After 24 hours, the mean umbilical cord blood concentration was less than 5 ng/mL. Neonatal hypoglycemia risk was increased with an odds ratio of hypoglycemia equal to 3.70 [1.40-9.77] for each 10 ng/mL increase in the cord blood glyburide concentration. However, no newborns were admitted to the NICU because of clinical signs of hypoglycemia or for treatment of hypoglycemia. Considering that neonatal glyburide exposure may be limited by stopping treatment a sufficient time before labor, there may still be a place for glyburide in the management of gestational diabetes.

Background In the Twin Birth Study, women at 32 0/7 –38 6/7 weeks of gestation, in whom the first twin was in cephalic presentation, were randomized to planned vaginal delivery or cesarean section. The study found no significant differences in neonatal or maternal outcomes in the two planned mode of delivery groups. We aimed to compare neonatal and maternal outcomes of twin gestations without spontaneous onset of labor, who underwent induction of labor or pre-labor cesarean section as the intervention of induction may affect outcomes. Methods In this secondary analysis of the Twin Birth Study we compared those who had an induction of labor with those who had a pre-labor cesarean section. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity. Secondary outcome was a composite of maternal morbidity and mortality. Trial Registration: NCT00187369. Results Of the 2804 women included in the Twin Birth Study, a total of 1347 (48%) women required a delivery before a spontaneous onset of labor occurred: 568 (42%) in the planned vaginal delivery arm and 779 (58%) in the planned cesarean arm. Induction of labor was attempted in 409 (30%), and 938 (70%) had a pre-labor cesarean section. The rate of intrapartum cesarean section in the induction of labor group was 41.3%. The rate of the primary outcome was comparable between the pre-labor cesarean section group and induction of labor group (1.65% vs. 1.97%; p  = 0.61; OR 0.83; 95% CI 0.43–1.62). The maternal composite outcome was found to be lower with pre-labor cesarean section compared to induction of labor (7.25% vs. 11.25%; p  = 0.01; OR 0.61; 95% CI 0.41–0.91). Conclusion In women with twin gestation between 32 0/7 –38 6/7 weeks of gestation, induction of labor and pre-labor cesarean section have similar neonatal outcomes. Pre-labor cesarean section is associated with favorable maternal outcomes which differs from the overall Twin Birth Study results. These data may be used to better counsel women with twin gestation who are faced with the decision of interventional delivery.