Indicators Of Neonatal Morbidity Research Articles

Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation: the PHOENIX RCT.

In women with late preterm pre-eclampsia (i.e. at 34+0 to 36+6 weeks' gestation), the optimal delivery time is unclear because limitation of maternal-fetal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether or not planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of perinatal or infant outcomes, compared with expectant management, in women with late preterm pre-eclampsia. We undertook an individually randomised, triple non-masked controlled trial in 46 maternity units across England and Wales, with an embedded health economic evaluation, comparing planned delivery and expectant management (usual care) in women with late preterm pre-eclampsia. The co-primary maternal outcome was a maternal morbidity composite or recorded systolic blood pressure of ≥ 160 mmHg (superiority hypothesis). The co-primary short-term perinatal outcome was a composite of perinatal deaths or neonatal unit admission (non-inferiority hypothesis). Analyses were by intention to treat, with an additional per-protocol analysis for the perinatal outcome. The primary 2-year infant neurodevelopmental outcome was measured using the PARCA-R (Parent Report of Children's Abilities-Revised) composite score. The planned sample size of the trial was 900 women; the trial is now completed. We undertook two linked substudies. Between 29 September 2014 and 10 December 2018, 901 women were recruited; 450 women [448 women (two withdrew consent) and 471 infants] were allocated to planned delivery and 451 women (451 women and 475 infants) were allocated to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group [289 (65%) women] than in the expectant management group [338 (75%) women] (adjusted relative risk 0.86, 95% confidence interval 0.79 to 0.94; p = 0.0005). The incidence of the co-primary perinatal outcome was significantly higher in the planned delivery group [196 (42%) infants] than in the expectant management group [159 (34%) infants] (adjusted relative risk 1.26, 95% confidence interval 1.08 to 1.47; p = 0.0034), but indicators of neonatal morbidity were similar in both groups. At 2-year follow-up, the mean PARCA-R scores were 89.5 points (standard deviation 18.2 points) for the planned delivery group (290 infants) and 91.9 points (standard deviation 18.4 points) for the expectant management group (256 infants), both within the normal developmental range (adjusted mean difference -2.4 points, 95% confidence interval -5.4 to 0.5 points; non-inferiority p = 0.147). Planned delivery was significantly cost-saving (-£2711, 95% confidence interval -£4840 to -£637) compared with expectant management. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group. In women with late preterm pre-eclampsia, planned delivery reduces short-term maternal morbidity compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater short-term neonatal morbidity (such as need for respiratory support). At 2-year follow-up, around 60% of parents reported follow-up scores. Average infant development was within the normal range for both groups; the small between-group mean difference in PARCA-R scores is unlikely to be clinically important. Planned delivery was significantly cost-saving to the health service. These findings should be discussed with women with late preterm pre-eclampsia to allow shared decision-making on timing of delivery. Limitations of the trial include the challenges of finding a perinatal outcome that adequately represented the potential risks of both groups and a maternal outcome that reflects the multiorgan manifestations of pre-eclampsia. The incidences of maternal and perinatal primary outcomes were higher than anticipated on the basis of previous studies, but this did not limit interpretation of the analysis. The trial was limited by a higher loss to follow-up rate than expected, meaning that the extent and direction of bias in outcomes (between responders and non-responders) is uncertain. A longer follow-up period (e.g. up to 5 years) would have enabled us to provide further evidence on long-term infant outcomes, but this runs the risk of greater attrition and increased expense. We identified a number of further questions that could be prioritised through a formal scoping process, including uncertainties around disease-modifying interventions, prognostic factors, longer-term follow-up, the perspectives of women and their families, meta-analysis with other studies, effect of a similar intervention in other health-care settings, and clinical effectiveness and cost-effectiveness of other related policies around neonatal unit admission in late preterm birth. The trial was prospectively registered as ISRCTN01879376. This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in Health Technology Assessment. See the NIHR Journals Library website for further project information.

Are newly introduced criteria for the diagnosis of gestational diabetes mellitus associated with improved pregnancy outcomes and/or increased interventions in New South Wales, Australia? A population-based data linkage study

IntroductionThe incidence of gestational diabetes mellitus (GDM) is increasing in Australia, influenced by changed diagnostic criteria. We aimed to identify whether the diagnostic change was associated with improved outcomes and/or...

Composite neonatal morbidity indicators using hospital discharge data: A systematic review.

Neonatal morbidity is associated with lifelong impairments, but the absence of a consensual definition and the need for large data sets limit research. To inform initiatives to define standard outcomes for research, we reviewed composite neonatal morbidity indicators derived from routine hospital discharge data. PubMed (updated on October 12, 2018). The search algorithm was based on three components: "morbidity," "neonatal," and "hospital discharge data." Studies investigating neonatal morbidity using a composite indicator based on hospital discharge data were included. Indicators defined for specific conditions (eg congenital anomalies, maternal addictions) were excluded. The target population, objectives, component morbidities, diagnosis and procedure codes, validation methods, and prevalence of morbidity were extracted. For each study, we assessed construct validity by describing the methods used to select the indicator components and evaluated whether the authors assessed internal and external validity. We also calculated confidence intervals for the prevalence of the morbidity composite. Seventeen studies fulfilled inclusion criteria. Indicators targeted all (n=4), low-/moderate-risk (n=9), and very preterm (VPT, n=4) infants. Components were similar for VPT infants, but domains and diagnosis codes within domains varied widely for all and low-/moderate-risk infants. Component selection was described for 8/17 indicators and some form of validation reported for 12/17. Neonatal morbidity prevalence ranged from 4.6% to 9.0% of all infants, 0.4% to 8.0% of low-/moderate-risk infants, and 17.8% to 61.0% of VPT infants. Multiple neonatal morbidity indicators based on hospital discharge data have been used for research, but their heterogeneity limits comparisons between studies. Standard neonatal outcome measures are needed for benchmarking and synthesis of research results.

Vacuum Assisted Vaginal Delivery in Singleton Term Pregnancies: Short Term Maternal and Neonatal Outcome in a Tertiary Hospital of Nepal

Introduction: Other than cesarean delivery, assisted vaginal delivery is an alternative procedure for delivery in emergency obstetrics. Presently, vacuum delivery has gained more popularity than forceps for operative/ assisted vaginal delivery, when and where indicated, with success as well as lesser neonatal and maternal complications. This study was done to estimate the short term maternal and fetal morbidity/mortality due to vacuum assisted vaginal delivery.
 
 Methods: A prospective observational study was conducted at Lumbini Medical College Teaching Hospital from January 2015 to May 2016. One hundred and four pregnant women who had successful vacuum assisted vaginal deliveries were enrolled. Fetal and maternal outcome were assessed.
 
 Results: One hundred and four successful vacuum deliveries (2.9%) were conducted among 3457 deliveries during our study period. Sixty seven (64.4%) were primigravida and most (n=59, 56.7%) parturients were of age group 20-30 years. The commonest (n=65, 62.5%) indication for vacuum application was prolonged second stage of labor. The maternal morbidity variables were: 6.7% (n=7) had genital tract injury, 3.8% (n=4) had primary post-partum hemorrhage, 3.8% (n=4) had urinary retention, 2.8% (n=3) needed blood transfusion. Among neonatal morbidity indicators, 19.2% (n=20) neonates had birth asphyxia, 4.8% (n=5) neonates had cephalohematoma, 0.96% (n=1) had brachial plexus injury. There was one early neonatal death due to meconium aspiration syndrome.
 
 Conclusion: A successful vacuum assisted delivery can be achieved with lesser maternal and neonatal morbidity with timely assessment of labor, skilled operator, and availability of neonatal team.

Relation between induced labour indications and neonatal morbidity.

To assess the main neonatal morbidity results in relation to induced labour indications. Historical groups from a total of 3,817 deliveries over a three year period (2009, 2010 and 2011) in "Mancha-Centro" Hospital (Alcázar de San Juan) formed the study group. All programmed and non-avoidable caesarean sections and pregnancies under 35 weeks were excluded. The main variable result was a neonatal morbidity variable made up of the Apgar score after 5 min, pH of umbilical artery <7.10 and the neonatal need for resuscitation type III-V. Multivariate analysis was used to control confounding variables. The incidence of induced labour was 22.6 % (862). The highest indication was premature rupture of membranes for more than 12 h 22.8 % (190), poorly controlled diabetes 22.6 % (189) and oligoamnios 16.2 % (135). The rate of pH lower than 7.10 was 2.8 % (22), the rate of the Apgar score lower than 7 after 5 min was 0.2 % (2) and the neonatal need for resuscitation type III-IV was 5.7 % (48) for induced labour. The relation between induced labour and neonatal morbidity indicators were not statistically significant. 10.1 % (4) of induced labour for suspected intrauterine growth restriction and 8.6 % (10) of postterm pregnancies required neonatal resuscitation type III-IV. No relation was found between induced labour and the neonatal morbidity indicators. The highest neonatal risk indicator is when a intrauterine growth restriction, hypertensión/preeclampsia or a postterm pregnancy is suspected.

Predictors of neonatal morbidity in fetuses with severe isolated congenital diaphragmatic hernia undergoing fetoscopic tracheal occlusion

To investigate neonatal morbidity in fetuses with severe congenital diaphragmatic hernia (CDH) treated with fetoscopic endoluminal tracheal occlusion (FETO) and compare it with historical controls with less severe forms of CDH that were managed expectantly. This was a prospective, multicenter study on neonatal outcomes and prenatal predictors in 90 FETO survivors (78 left-sided, 12 right) and 41 controls from the antenatal CDH registry with either severe or moderate hypoplasia who were managed expectantly. We also investigated early neonatal morbidity indicators, including the need for patch repair, duration of mechanical ventilation and supplemental oxygen, age at full enteral feeding and incidence of pulmonary hypertension. Gestational age at delivery was predictive of duration of assisted ventilation (P = 0.046), days on supplemental oxygen (P = 0.019) and age at full enteral feeding (P = 0.020). When delivery took place after 34 weeks' gestation, neonatal morbidity of FETO cases was comparable with that of expectantly managed cases with moderate hypoplasia. Fetal intervention for severe CDH is associated with neonatal morbidity that is comparable with that of an expectantly managed group with less severe disease.

Severe Fetal Acidemia Does Not Predict the Grade of Hypoxic-Ischemic Encephalopathy (HIE) Assigned Before the Inclusion in Hypothermic Therapy

Background and aims: Severe acidemia at birth has been related with a greater risk of HIE, neonatal seizures and death. We questioned if the degree of fetal acidemia correlates with indicators of neonatal morbidity as the severity of HIE before starting hypothermia, magnetic resonance imaging and neonatal death in asphyxiated infants evaluated to be included in a program of hypothermia.

Membrane sweeping and prevention of post‐term pregnancy in low‐risk pregnancies: a randomised controlled trial

To evaluate the effectiveness of membrane sweeping at 41 weeks for the prevention of post-term pregnancy. A multicentre randomised controlled trial. Fifty-one primary care midwifery practices in the Netherlands. A total of 742 low-risk pregnant women at 41 weeks of gestation. Participants were randomly assigned to serial sweeping of the membranes (every 48 hours until labour commenced up to 42 weeks of gestation) or no intervention. Post-term pregnancy (>or=42 weeks). Subgroup analyses were performed on nulliparous and parous women. Secondary outcomes included adverse effects. Serial sweeping of the membranes at 41 weeks decreased the risk of post-term pregnancy (87/375 [23%] versus 149/367 [41%]; relative risk [RR] 0.57, 95% CI 0.46-0.71; number needed to treat [NNT] 6 [95% CI 4-9]). Benefits were also seen in both subgroups (nulliparous: 57/198 [29%] versus 89/192 [46%]; RR 0.62 [95% CI 0.48-0.81]; NNT 6 [95% CI 4-12] and parous: 30/177 [17%] versus 60/175 [34%]; RR 0.49 [95% CI 0.34-0.73]; NNT 6 [95% CI 4-6]). Adverse effects were similar in both the groups except for uncomplicated bleeding, which was reported more frequently in the sweeping group. Other obstetric outcomes and indicators of neonatal morbidity were similar in both groups. There were two perinatal deaths in each group. Membrane sweeping at 41 weeks can substantially reduce the proportion of women with post-term pregnancy.

Neonatal Outcome and Its Relationship with Maternal Age

The relationship between maternal age and neonatal outcome was examined in 22,689 pregnancies using various determinants of neonatal well-being which included evidence of fetal distress, birth-weight, Apgar scores, the necessity for admission to the neonatal unit and other indicators of neonatal morbidity. Differences in the incidence of congenital malformations and perinatal mortality were also studied. There was a trend towards more frequent fetal heart monitoring, lower birth-weight and a higher rate of neonatal unit admission for infants delivered by younger women. There was also a significant increase in the Caesarean section rate with advancing maternal age. Maternal age had no effect, however, on the incidence of fetal distress, Apgar score, the development of respiratory disease, the need for intubation and ventilation nor on subsequent neonatal central nervous system complications. There was also no association between maternal age and either perinatal mortality or the incidence of congenital malformations. The favourable outcome in teenagers in this study may have been influenced by the extremely low pregnancy rate amongst young adolescents in Hong Kong, but a similar outcome in the mature age women was likely to have reflected the recognition of risk and its appropriate management.