Neonatal Adverse Events Research Articles

Vaginal birth after caesarean section: a multicentre study on prognostic factors and feasibility.

Vaginal birth after caesarean (VBAC) is an option to avoid major abdominal surgery and many consequences related to repeated caesarean delivery. In the last years, many efforts have been made to increase the number of patients attempting trial of labour after caesarean (TOLAC). The aim of our study was to identify the most important factors associated with the success of VBAC. A retrospective study was conducted in two Italian referral centres. Subjects included were singleton and morphologically normal pregnancy with previous C-section. Subjects with an inter-pregnancy interval shorter than 18months, a large for gestational age baby, a pregnancy complicated with gestational diabetes and a previous unclassified uterine scar were excluded. The characteristics of the subjects were compared and a logistic regression was performed to evaluate variables associated with successful VBAC. Of the 300 patients included, 224 (74.7%) achieved VBAC while 76 (25.3%) underwent C-section after failed TOLAC. The number of previous C-sections was not significantly associated with the success of TOLAC. Factors positively associated with achievement of VBAC were previous vaginal delivery (OR of 6.88 for one and 9.68 for more than one) and oxytocin implementation (OR 3.32). No maternal and neonatal adverse events occurred. Our results show that attempting VBAC is a feasible option in referral centres after adequate evaluation of the potential factors affecting the probability of success. A careful record of obstetrical history and management of labour can provide clinicians useful information to counsel women before and during labour.

Client satisfaction with existing postnatal care and associated factors: A study among mothers in Awi Zone, Amhara region, Ethiopia.

Background:The majority of maternal and neonatal adverse events take place during the postnatal period. However, it is the most neglected period for the provision of quality care.Objective:The aim of this study among mothers in the Awi Zone, Amhara region, Ethiopia, was to assess client satisfaction with existing postnatal care and associated factors.Methods:An institution-based cross-sectional study was conducted in Awi Zone hospitals from 1 to 30 April 2018. A total of 422 post-partum mothers were selected by systematic sampling. The data were collected using a pre-tested structured questionnaire via a face-to-face interview. Data entry and analysis were completed using EpiData version 3.1 and SPSS version 22, respectively. The data were summarized with frequency and cross-tabulation. Both binary and multiple logistic regressions were used to identify predictor variables using odds ratios and 95% confidence intervals.Result:The prevalence of postnatal care satisfaction was 63%. Being from urban area (AOR = 2.1, 95% CI = (1.11–3.99)), having a history of antenatal care follow up (AOR = 1.62, 95% CI = (1.23–1.64)), spontaneous vaginal birth (AOR = 3.14, 95% CI = (1.77–3.28)), and those who did not face any complications during birth (AOR = 2.90, 95% CI = (1.47–1.69)) were some of the factors associated with client satisfaction.Conclusion:According to the results of this study, the majority of mothers were satisfied with post-partum care services. The study findings indicate that maternal satisfaction on post-partum care is mainly affected by residency, antenatal care follow up, mode of delivery, and complications during birth. Therefore, health care providers and other concerned bodies should give special attention to those mothers who are from rural areas, who face complications during birth or who have instrumental-assisted or cesarean section birth. Also, every pregnant mother should be supported to have at least four regular antenatal care visits.

Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial

Preterm birth remains a common cause of neonatal mortality, with a disproportionately high burden in low-income and middle-income countries. Meta-analyses of low-dose aspirin to prevent pre-eclampsia suggest that the incidence of preterm birth might also be decreased, particularly if initiated before 16 weeks of gestation. ASPIRIN was a randomised, multicountry, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy. Participants were enrolled at seven community sites in six countries (two sites in India and one site each in the Democratic Republic of the Congo, Guatemala, Kenya, Pakistan, and Zambia). Participants were randomly assigned (1:1, stratified by site) to receive aspirin or placebo tablets of identical appearance, via a sequence generated centrally by the data coordinating centre at Research Triangle Institute International (Research Triangle Park, NC, USA). Treatment was masked to research staff, health providers, and patients, and continued until 36 weeks and 7 days of gestation or delivery. The primary outcome of incidence of preterm birth, defined as the number of deliveries before 37 weeks' gestational age, was analysed in randomly assigned women with pregnancy outcomes at or after 20 weeks, according to a modified intention-to-treat (mITT) protocol. Analyses of our binary primary outcome involved a Cochran-Mantel-Haenszel test stratified by site, and generalised linear models to obtain relative risk (RR) estimates and associated confidence intervals. Serious adverse events were assessed in all women who received at least one dose of drug or placebo. This study is registered with ClinicalTrials.gov, NCT02409680, and the Clinical Trial Registry-India, CTRI/2016/05/006970. From March 23, 2016 to June 30, 2018, 14 361 women were screened for inclusion and 11 976 women aged 14-40 years were randomly assigned to receive low-dose aspirin (5990 women) or placebo (5986 women). 5780 women in the aspirin group and 5764 in the placebo group were evaluable for the primary outcome. Preterm birth before 37 weeks occurred in 668 (11·6%) of the women who took aspirin and 754 (13·1%) of those who took placebo (RR 0·89 [95% CI 0·81 to 0·98], p=0·012). In women taking aspirin, we also observed significant reductions in perinatal mortality (0·86 [0·73-1·00], p=0·048), fetal loss (infant death after 16 weeks' gestation and before 7 days post partum; 0·86 [0·74-1·00], p=0·039), early preterm delivery (<34 weeks; 0·75 [0·61-0·93], p=0·039), and the incidence of women who delivered before 34 weeks with hypertensive disorders of pregnancy (0·38 [0·17-0·85], p=0·015). Other adverse maternal and neonatal events were similar between the two groups. In populations of nulliparous women with singleton pregnancies from low-income and middle-income countries, low-dose aspirin initiated between 6 weeks and 0 days of gestation and 13 weeks and 6 days of gestation resulted in a reduced incidence of preterm delivery before 37 weeks, and reduced perinatal mortality. Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Gestational Age of Delivery in Pregnancies Complicated by Diabetes.

Background: The recommended gestational age to deliver pregnancies complicated by diabetes ranges from 34 to 39 weeks of gestation. The objective of this study was to determine the optimal gestational age for delivery of patients with diabetes to minimize perinatal death.Methods: We extracted a population-based cohort of singleton, nonanomalous infants of diabetic pregnancies from the Missouri birth registry for the period January 1, 1989 to December 31, 2005 and compared perinatal outcomes of planned deliveries at 37, 38, 39, and 40 weeks to expectant management. Planned deliveries were identified by induction or cesarean delivery without documented medical or obstetric indications. The primary outcome was perinatal death, defined as stillbirth or neonatal death within 28 days of birth. Secondary outcomes were independent stillbirth, independent neonatal death, and a composite adverse neonatal event of assisted ventilation >30 minutes, birth injury, seizures, or 5-minute Apgar score ≤3. Groups were compared using t test and chi-square as appropriate.Results: In 4,905 diabetic pregnancies reaching 37 weeks, 1,012 (20.6%) patients were insulin dependent. Overall, the risk of perinatal death at any gestational age examined was low (3/1,000 births or lower), as was the risk of the adverse perinatal outcome (<2%). When only patients who were insulin dependent were included in the analysis, the risk of perinatal death at any gestational age remained low at 6 per 1,000 births or fewer.Conclusion: Delivery as early as 37 weeks is reasonable for women who have diabetes, although the absolute risk of perinatal death is low at 37 to 39 weeks.

309: Foley balloon insertion by blind placement versus direct visualization: A randomized controlled trial (FRIENDLY)

To test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection. Pregnant women >37 weeks undergoing induction of labor with unfavorable cervix (< 3 cm and < 60% effaced) were randomly assigned to balloon catheter placed either digitally (DP) or using a sterile speculum (SS). The cervix was cleaned with Betadine before insertion in the SS group. The balloon was inflated with 60 mL of sterile saline and left up to 12 hours. If the cervix remained unfavorable, one more round of balloon ripening was performed. All other management, including the use of oxytocin, was left to the discretion of the clinical providers. The primary outcome was a composite of maternal infection, defined by occurrence of fever, chorioamnionitis, or endometritis. Secondary outcomes are listed in Table. Patients completed a satisfaction survey. On the basis of a non-inferiority margin of 10% and an expected primary outcome frequency of 10%, a sample size of 372 women was needed (90% power to confirm non-inferiority with 90% protocol adherence). 372 women were randomized (185 digital, 187 speculum). Composite maternal infection rate was higher in the digital arm (15.7% vs. 12.8%), with an absolute difference with respect to the speculum arm of 2.8% (95% CI -4.3% to 9.9%), indicating non-inferiority for the pre-specified margin (Figure). Secondary outcomes were not different between groups, except for higher need for a second balloon catheter in the speculum arm (Table). Maternal and neonatal adverse events and responses on the satisfaction survey were not different between groups. Digital placement of a balloon catheter for pre-induction cervical ripening is non-inferior to the sterile-speculum method in terms of maternal infection. Women in the sterile speculum group required a second round of the mechanical dilator more frequently. The blind digital approach is a reasonable option for balloon placement for cervical ripening.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

436: Effect of tranexamic acid dose on clot lysis: implications for preventing postpartum hemorrhage

Tranexamic acid (TXA) reduces bleeding when administered during postpartum hemorrhage. The pharmacodynamics of TXA in the obstetric population are unknown. Since pregnancy is a hypercoagulable state, it is important to determine the lowest effective dose for prevention. Our objective was to determine pharmacodynamic relationships between TXA administered at cesarean delivery and clot lysis. We administered 5, 10 and 15 mg/kg (max 1 g) of intravenous TXA to pregnant women at time of umbilical cord clamp. Inclusion criteria were scheduled cesarean delivery >34 wks gestation and normal renal function. Exclusion criteria were known thrombophilia or anticoagulation. We collected blood prior to delivery (A), and after TXA administration (B:< 10 min, C:30-60 min, D:1.5-3 hrs, E:4-6 hrs, F:7-8 hrs and G:24 hrs, Figure). We performed rotational thromboelastometry (ROTEM) using whole blood and whole blood spiked with tissue plasminogen activator (tPA). The primary outcome was maximum lysis (ML), which reflects extent of clot lysis, in samples spiked with tPA. Thirty women were enrolled and 28 completed all blood draws. Women were 32 ± 5.1 years old (mean±SD), 38 weeks (range 34-39) in gestation, and had a body mass index of 34.7 ± 8.5 kg/m2. For all TXA doses combined, pre-delivery clot lysis was nearly 100% and post TXA infusion approached 100% with each successive half-life (t1/2=2.5 hours) (Table). The 5 mg/kg group received 0.45±0.09 g TXA. Average ML in the 5 mg/kg group differed between times C and D (p=0.0057) but in the higher dose groups this difference was seen between times D and E (10 mg/kg p=0.0001, 15 mg/kg p< 0.0001) (Figure). There were no serious adverse maternal or neonatal events. ROTEM shows TXA inhibits tPA-induced clot lysis in a dose-dependent manner. Higher TXA dose produced more sustained antifibrinoytic effects; however, even 5 mg/kg TXA effectively inhibited fibrinolysis for 4-6 hours after cord clamp. Low-dose TXA may provide safe and effective antifibrinolytic activity for prevention of postpartum hemorrhage.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Severe antepartum hypertension and associated peripartum morbidity among pregnant women in an urban tertiary care medical center.

Hypertensive disorders of pregnancy are a leading cause of maternal morbidity and mortality. Although acute severe hypertension carries with it a poor prognosis, treatment is often delayed and not universal. A total of 654 patients were assessed for the impact of hypertensive disorders of pregnancies on maternal and fetal morbidity and divided into three groups: normotensive (Group I, N=306), non-severe hypertension (Group II, N=248) and severe-range hypertension with blood pressure (BP) episodes ≥160 systolic or ≥105 diastolic (Group III, N=100). Retrospective demographic and medical information was abstracted from patients' medical records to collect study data. The main outcomes assessed were composite maternal adverse events,fetal adverse events, and time to treatment. Patients in Group III had higher systolic (182 vs 155 vs 133) and diastolic (106 vs 95 vs 81) BPs compared to patients in Groups II and I. Patients in Group III had a significantly higher incidence of maternal adverse events (26.0% vs 6.5% vs 2.0%, respectively; p<0.001) and higher neonatal composite adverse events (52.0% vs 17.7% vs 26.1%, respectively; p<0.001) as compared to patients in Groups II and I. Only 52.2% of patients in Group III were treated within recommended 60minutes or less. Patients with severe hypertension antepartum have higher associated maternal and fetal adverse events while treatment is often delayed. Further studies should evaluate the effects of adequate time to treatment for severe hypertension. Steps should also be taken to standardize identification and reporting of severe maternal morbidity.

The Edmonton Obesity Staging System Predicts Mode of Delivery After Labour Induction.

This study sought to evaluate the use of the Edmonton Obesity Staging System (EOSS) in predicting cesarean delivery among term, nulliparous, singleton pregnancies in women with overweight or obesity who are undergoing an induction of labour. A prospective cohort study was performed in Edmonton, Alberta. Women undergoing an induction of labour at term were recruited to either a sample cohort, including women with a body mass index of ≥25 kg/m2 at first antenatal visit, or a control cohort with a body mass index of 18.5 to 24.9 kg/m2. Participating women provided a self-reported health history and consented to review of their medical records allowing allocation into EOSS categories. The primary outcome was the rate of cesarean delivery based on EOSS category. Secondary outcomes consisted of a summary score of adverse maternal, delivery, and neonatal events (Canadian Task Force Classification II-2). Overall, 345 women were recruited, with a participation rate of 93.7%. The sample cohort consisted of 276 women with overweight or obesity, whereas the control cohort included 69 normal-weight women. The overall rate of cesarean delivery was 30.4% for the control cohort and 35.8%, 29.9%, 43.2%, and 90.5% for women assigned an EOSS category 0, 1, 2, and 3, respectively (P < 0.001). A summary score was not indicative of overall rate of adverse maternal, delivery, and neonatal events (P = 0.22). The EOSS may help predict the chance of cesarean delivery in a high-risk group of nulliparous women with overweight or obesity who are undergoing an induction of labour at term.

Client perceived quality of the postnatal care provided by public sector specialized care institutions following a normal vaginal delivery in Sri Lanka: a cross sectional study

BackgroundMajority of the maternal and neonatal adverse events take place during the postnatal period. Provision of high-quality care during this period can minimize these events. Assessment of mothers’ perceptions of the quality of care received by them provides valuable feedback to improve the care and ultimately outcomes.MethodsA cross sectional survey was conducted in specialized institutions of Colombo district, Sri Lanka, to assess the maternal perceptions of the quality of regular postnatal care and its correlations, using an interviewer administered questionnaire. The questionnaire contained 23 items distributed under three main domains: technical and information domain, interpersonal care domain and ward facilities and cleanliness domain. Each item was given a score from 1 to 5 and total scores were calculated for the total questionnaire and for each domain. Descriptive statistics were used to assess the perceptions and multivariate analysis was conducted to assess the significant correlates of positive perceptions.ResultsThe median score obtained for the questionnaire was 108, (Inter Quartile Range 96–114). The median scores of the technical care and information domain, interpersonal care domain and ward facilities and cleanliness domain were 43 (IQR 38–45), 33 (IQR 30–35) and 32 (IQR 28–35) respectively. Attending teaching/ specialized hospitals (aOR=1.6, p < 0.001), 20–35 age group (1.8, p = 0.024), and services such as initiation of breast feeding within 1 h of delivery (2.1, p = 0.009), pain relief during episiotomy suturing (2.2, p < 0.001), practicing Kangaroo Mother Care (1.4, p = 0.035), receiving health advices by doctors or midwives (2.1, p < 0.001) were significant correlates of positive perceptions.ConclusionsMajority of mothers had favourable perceptions of the quality of care received by them. However, the ward facilities and environment domain has obtained lower ratings compared to technical and interpersonal care domains. Several services were significantly associated with favourable perceptions. Authorities should consider these findings when attempting to improve care quality. Further, this assessment should be carried out regularly to obtain more current data.

A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

BackgroundPreterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix.MethodsThis is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks.The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm).Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis.DiscussionIn clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth.Trial registrationBrazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111–1164-2636, 2014/11/18.

Prediction of maternal diabetes and adverse neonatal outcome in normotensive pregnancy using serum uric acid

Diabetes mellitus, with adverse neonatal events are challenging issues to all obstetricians and pediatricians, where uric acid could play a vital role. We aimed to assess the relationship and prognostic benefits of serum uric acid measured at about 20 weeks’ gestation in normotensive pregnancy, with subsequent maternal diabetes, and neonatal complications. All singleton normotensive pregnant women with normal blood glucose, serum creatinine, and weight before pregnancy, whom attended Medical City Hospital, Department of Obstetrics and Gynecology in Baghdad, were involved and regarded as the case group, on the condition that their serum uric acid measured at 20 weeks’ gestation &gt; 3 mg/dl, but if ≤ 3 mg/dl, they would be registered as a control group. A complete follow up was performed regularly during pregnancy, and after delivery; regular assessments of maternal blood glucose were done up to one year. Maternal diabetes mellitus (DM), small for gestational age (SGA) neonates, and preterm delivery (PD) constituted (27.59%), (43.60%), and (1.97%), respectively in case group which had significantly included maternal DM and SGA (P &lt;0.001). Also, elevated mid-pregnancy serum uric acid was strongly associated (P &lt;0.0001) with maternal DM (5.86 ± 0.69) and SGA (4.78 ± 0.34). Cut-off values of uric acid of 4.76 mg/dl were best associated with maternal DM, while 4.33 mg/dl with SGA. In conclusion, the cut-off points of 4.76 and 4.33 mg/dl of maternal mid- normotensive pregnancy serum uric acid have the potential ability to predict Maternal DM and SGA, respectively.

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial

Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. WHO, India.

315. Prenatal Hepatitis C Viral (HCV) Screening Practices and HCV-Associated Fetal, Neonatal and Pregnancy Outcomes in a Large Regional Healthcare System

BackgroundPrevalence of HCV in pregnancy is 0.1–3.6%. AASLD and IDSA now recommend HCV screening in pregnancy although CDC, USPSTF, or ACOG still do not—though HCV can be perinatally transmitted and carries associated complications for the mother and fetus. Our study objectives were to analyze prenatal HCV screening practices at a large regional healthcare system and the prevalence of HCV-associated maternal and fetal/neonatal outcomes.MethodsWe performed a nested propensity score (PS) case–control study of pregnant women who tested HCV Ab+ in a cross-sectional study of women presenting for prenatal care at a large regional healthcare system from January 17 to December 18. We collected retrospective EHR data, including state of residency, HCV Ab, RNA, care engagement, HCV risk factors, comorbidities, maternal and fetal/neonatal morbidity, and neonatal HCV testing (when available). Mixed and generalized linear models were used to examine differences in continuous and categorical variables, respectively, between cases and controlsResults14,363 women were seen for prenatal care; 4,891 (34%) were HCV tested, 75 (1.5%) tested HCV Ab+. Demographic and comorbidity data are shown in Table 1. HCV Ab+ cases had more co-morbidities, including obesity, heart disease, opioid use, and behavioral health issues compared with the controls. HCV risk factors included IVDU (64%) and tattoos (24%) (Figure 1). Neither past/current pregnancy-related complications nor fetal or neonatal adverse events (Figure 2) were statistically significantly different except for cholestasis in HCV Ab+ cases (5.3 vs. 0%, P = 0.04).ConclusionOur study showed only one-third of pregnant women are currently HCV screened in our health system. Universal screening would likely increase the number of HCV-infected women identified. Early HCV detection, repeated testing, and behavioral health intervention of those at high-risk may decrease further horizontal and vertical transmission of HCV in pregnancy. Disclosures All authors: No reported disclosures.

Risk factors associated with adverse events in neonates with peripherally inserted central catheter

BackgroundPeripherally inserted central catheters have become a priority in infants who require long-term intravenous therapy, but their use involves certain risks. ObjectiveThe aim of the study was to describe the occurrence of adverse events in newborns with peripherally inserted central catheters and to determine the risk factors associated with them. MethodsA descriptive cross-sectional study was designed and performed. All neonates with peripherally inserted central catheters from October 1st, 2014 to September 30th, 2015 were included. The adverse events and sociodemographic and clinical variables related to neonates and analysed catheters were recorded. ResultsA total of 140 catheters were placed in 116 infants. All of them were analysed. Adverse events occurred in 16.4%: catheter-associated bacteraemia (5.7%), obstruction (5.7%), extravasation (2.1%) and phlebitis (2.1%), <27 weeks of pregnancy (OR=1.2, p=.02), birth weight <1000g (OR=6.7, p=.02), with catheters in situ for longer than one week (OR=9.8, p=.02) and with perfusion of antibiotics per catheter (OR=1.3, p<.01). Phlebitis is associated with the insertion of the catheter in LL and head (OR=1.1, p=.03). Factors associated with bacteraemia risk with adjusted prevalence odds ratio are extremely low birth weight neonates (OR=6.38; p=.03) and with a catheter in situ for longer than one week (OR=9.41; p=.04). ConclusionsThe periodic evaluation of catheter-related adverse events is very useful to prepare improvement plans. This will maximise safety for the most vulnerable newborns, especially those of extremely low birth weight that require very long treatments.

Maternal and neonatal outcomes in women with history of coronary artery disease

BackgroundPregnancy outcomes in women with pre-existing coronary artery disease (CAD) are poorly described. There is a paucity of data therefore on which to base clinical management to counsel women, with...

Importance of early elevated maternal HbA1c levels in identifying adverse fetal and neonatal events

AimsThe aims of this study were to explore factors that associated with gestational diabetes mellitus (GDM), and to determine the relationship between early maternal HbA1c levels and adverse fetal or neonatal events, and to determine an optimal maternal glucose testing method in order to decrease the potential health risk for their offspring. MethodsFrom December 2015 to May 2016, a total of 6744 pregnant women were enrolled from Shanghai First Maternal and Infant Hospital affiliated to Tongji University prospectively in the nested case-control study. Each GDM case was matched with a healthy pregnant woman and followed up. Outcome analyses were conducted between GDM case and control groups, as well as elevated and normal maternal HbA1c levels, respectively. ResultsA total of 1836 women were included in the adverse fetal and neonatal events examination. For pregnant women with early HbA1c ≥ 5.2%, the adjusted risk ratios (RR) of respiratory distress syndrome (RDS), pneumonia and jaundice were 4.37 (95%CI 1.54–12.35), 2.03 (95%CI 1.24–3.33) and 1.49 (95%CI 1.01–2.20), respectively. After treatments, the frequency for the majority of events in GDM group was similar to that of healthy pregnant women. Moreover, the area under the curve (AUC) of early maternal HbA1c in predicting potential RDS is 0.734. HbA1c ≤ 4.9% excluded for RDS. ConclusionsCompared with women with normal HbA1c, those with an early elevated HbA1c level were more likely to develop adverse events, including RDS, pneumonia and jaundice. Early HbA1c testing can be used as an auxiliary method identifying potential RDS.

Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial.

Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor with a long half-life, high selectivity, and rapid onset of action. Because the safety of using PDE5 inhibitors as therapeutic agents for fetal growth restriction (FGR) has been a problem worldwide, this paper primarily focuses on the safety assessments performed in the Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER) II population. Neonatal and maternal adverse events were analyzed, in addition to fetal, neonatal, and infant death cases, six months after stopping the trial. Eighty-nine pregnant women with FGR were studied between September 2016 and March 2018 (45 and 44 in the tadalafil and conventional treatment groups, respectively). Seven (16%) deaths (four fetal, one neonatal, and two infant) in the control group, whereas only one neonatal death occurred in the tadalafil group. Although headache, facial flushing, and nasal hemorrhage occurred more frequently in the tadalafil group, these symptoms were Grade 1 and transient. In conclusion, this trial showed that tadalafil decreased the fetal and infant deaths associated with FGR. This is thought to be primarily due to pregnancy prolongation. Further studies are warranted to evaluate the efficacy of tadalafil in treating early-onset FGR.

Phase-1 clinical study of tadalafil administered for selective fetal growth restriction in twin pregnancy

Background Selective fetal growth restriction (sFGR) is a condition of twin pregnancy in which the development of one fetus is restricted, despite normal growth of the other fetus. A method of intrauterine therapy for sFGR does not currently exist. The only treatment for sFGR is to terminate the pregnancy before the FGR worsens. In twin pregnancies, maternal and intrauterine environments are common in both fetuses, thus a placental factor is considered the cause of FGR in fetuses. Tadalafil is a phosphodiesterase (PDE)-5 inhibitor that induces an increase in uterine blood flow by dilatation of blood vessels in cases of FGR with placental dysfunction, which improves FGR. Purpose The aim of this study was to investigate the safety and maximum tolerated dose (MTD) of tadalafil administered for twin pregnancy (diamniotic-monochorionic twin or diamniotic-dichorionic twin). Methods In this phase I, open-label, dose-escalation trial, sequential patient cohorts (3 + 3 dose-escalation design) for twin pregnancy received tadalafil (20 or 40 mg/d) as a single dose by oral administration from the day they were diagnosed with sFGR, defined as estimated fetal weight (EFW) < 3% tiles, that is, −1.8 SD the mean EFW for gestational age (GA) to unacceptable toxicity or the day of delivery. This study evaluated the safety of maternally administered tadalafil for sFGR, examining maternal, fetal, and neonatal adverse events. Maternal adverse events were graded on the basis of the Common Terminology Criteria for Adverse Events v4.0. Results Six women with sFGR who were pregnant with twins were treated with tadalafil. There were no severe adverse events in either cohort, although the most common (≥3 patients) drug-related adverse events were headache and heart failure. The MTD of tadalafil among Japanese patients was 40 mg. Conclusions Tadalafil has a manageable safety profile up to an MTD of 40 mg/d.

Induction opioids for caesarean section under general anaesthesia: a systematic review and meta-analysis of randomised controlled trials

IntroductionThe adverse effects of induction opioids on the neonate are poorly characterised. The study aim was to investigate whether induction opioids can be used in caesarean section without adversely affecting the neonate. MethodsSix databases were systematically searched from inception until January 2019. Included studies compared induction opioids and placebo in caesarean section. Results were presented as odds ratios (95% confidence intervals) for dichotomous outcomes and weighted mean difference for continuous outcomes. An I2 statistic of >50% was significant for heterogeneity. The primary outcome was Apgar score (1 and 5 min). Secondary outcomes included neonatal adverse events, cord blood gas analyses, maternal haemodynamic parameters (systolic blood pressure (SBP), mean arterial pressure (MAP), heart rate (HR) and catecholamine concentrations. ResultsSeventeen studies (n=987) were included in the meta-analysis. Remifentanil 0.5–1 μg/kg or 2–3 μg/kg/h, alfentanil 7.5–10 μg/kg and fentanyl 0.5–1 μg/kg were compared to placebo. There was no significant difference in Apgar scores at 1 min (P=0.25, 0.58 and 0.89 respectively) for all three opioids or at 5 min for remifentanil and alfentanil (P=0.08 and 0.21 respectively). Fentanyl significantly reduced 5 min Apgar scores (P=0.002). There was no difference in neonatal airway interventions with remifentanil or alfentanil (P <0.05). All three induction opioids caused a significant reduction in maximum SBP (P <0.0001), MAP (P <0.00001) and HR (P <0.00001). ConclusionInduction opioids are effective sympatholytic agents. Remifentanil and alfentanil appear to be safe, with no significant effect on Apgar scores or neonatal airway intervention, but a well-powered trial is required to confirm these findings.

Association of Adult Congenital Heart Disease With Pregnancy, Maternal, and Neonatal Outcomes

With the help of medical advances, more women with adult congenital heart disease (ACHD) are becoming pregnant. Adverse maternal, obstetric, and neonatal events occur more frequently in women with ACHD than in the general obstetric population. Adult congenital heart disease is heterogeneous, yet few studies have assessed whether maternal and neonatal outcomes differ across ACHD subtypes. To assess the association of ACHD and its subtypes with pregnancy, maternal, and neonatal outcomes. This cross-sectional study used data from the Discharge Abstract Database, which contains information on all hospitalizations in Canada (except Quebec) from fiscal years 2001-2002 through 2014-2015. Discharge Abstract Database information was linked with maternal and infant hospital records across Canada. All women who gave birth in hospitals during the study period were included in the study. Data were analyzed from December 18, 2017, to March 22, 2019. Women with ACHD were identified using diagnostic and procedural codes. Subtypes of ACHD were classified using the Anatomic and Clinical Classification of Congenital Heart Defects scheme. Primary outcomes were defined a priori and included severe maternal morbidity (measured using the Maternal Morbidity Outcomes Indicator), neonatal morbidity and mortality (measured using the Neonatal Adverse Outcomes Indicator), ischemic placental disease, preterm birth, congenital anomalies, and small-for-gestational-age births. Absolute and relative rates of each outcome were calculated overall and by ACHD subtype. Logistic regression using generalized estimating equations assessed crude and adjusted odds ratios (aORs) for each outcome in women with ACHD compared with women without ACHD after adjustment for comorbidities, mode of delivery, and study year. The 2114 women with ACHD included in the analysis (mean [SD] age, 29.4 [5.7] years) had significantly higher odds of maternal morbidity (aOR, 2.7; 95% CI, 2.2-3.4) and neonatal morbidity and mortality (aOR, 1.8; 95% CI, 1.6-2.1) compared with women without ACHD (n = 2 682 451). Substantial variation was observed between women with different subtypes of ACHD. For example, the aORs of preterm birth (<37 weeks) varied from 0.4 (95% CI, 0.4-0.5) for women with anomalies of atrioventricular junctions and valves to 4.7 (95% CI, 2.9-7.5) for women with complex anomalies of atrioventricular connections. These results suggest that women with different subtypes of ACHD are not uniformly at risk for adverse maternal and neonatal outcomes. Although some women with ACHD can potentially expect healthy pregnancies, it appears that clinical care should be modified to address the heightened risks of certain ACHD subtypes.