Severe Adverse Perinatal Outcomes Research Articles

Cost-Effectiveness of Routine Third Trimester Ultrasound Screening for Fetal Growth Restriction Compared to Care as Usual in Low-Risk Pregnancies: A Pragmatic Nationwide Stepped-Wedge Cluster-Randomized Trial in The Netherlands (the IRIS Study).

Routine third trimester ultrasonography is increasingly used to screen for fetal growth restriction. However, evidence regarding its cost-effectiveness is lacking. We aimed to evaluate the cost-effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes compared to usual care (selective ultrasonography). An economic evaluation alongside a stepped-wedge cluster-randomized trial was conducted. Via 60 midwifery practices 12,974 Dutch women aged ≥16 years with low-risk pregnancies were enrolled at 22.8 (SD = 2.4) weeks’ gestation. All practices provided usual care. At 3, 7, and 10 months a third of the practices were randomized to the intervention strategy providing routine ultrasonography at 28–30 and 34–36 weeks’ gestation and usual care. The primary clinical outcome was a dichotomous composite measure of 12 severe adverse perinatal outcomes (SAPO) up to one week postpartum. Information on perinatal care and societal costs was derived from Netherlands Perinatal Registry, hospital records and a survey. Cost-effectiveness analyses revealed no significant differences in SAPO and healthcare and societal costs between the intervention strategy (n = 7026) and usual care (n = 5948). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was never higher than 0.6 for all possible ceiling ratios. Adding routine third trimester ultrasonography to usual care is not cost-effective in reducing SAPO.

Impact of suspected late-onset fetal growth restriction on obstetrical interventions and perinatal outcomes at term; a retrospective cohort study

ObjectivesFirst, assess accuracy of late third trimester universal fetal growth screening in high risk nulliparous women with a singleton in vertex presentation at term. Second, assess instrumental delivery rates and perinatal outcomes in this population. Study designSingle centre retrospective cohort study in a teaching hospital, The Netherlands. ResultsIn a cohort of 1902 pregnancies, growth ultrasound after 33 weeks was moderately accurate in detecting children with a birthweight below the 10th centile with a sensitivity of 46.2% and a false positive rate of 4.7%. Induction of labour followed an antenatal suspicion of FGR more often than in the group with normal expected fetal weight (73.4% vs 52.6% OR 2.49 (1.88–3.3)) as could be expected from application of guidelines. The caesarean section rates was lowest in the group with suspected FGR compared to the group with expected normal fetal weight (15.2% vs 22.1% OR 0.63 (0.45–0.9)). There were no differences between both groups in rates of composite severe adverse perinatal outcome (0.7% vs 0.8% OR 0.87 (0.2–3.93)). ConclusionsThe detection of growth restriction using universal screening in term high risk nulliparous women with a singleton in vertex position is moderate. Despite this, caesarean section rates were not increased and perinatal outcomes were similar when compared to that found in the randomized controlled trial on which the recommendation for induction of labour for suspected term FGR is based. This supports universal late third trimester fetal growth screening in pregnancies under consultant-led care in the two tiers Dutch obstetrical system.

Pregnancy-Related and Perinatal Outcomes in Women With Multiple Sclerosis: A Nationwide Danish Cross-sectional Study.

To investigate differences in pregnancy-related and perinatal outcomes in women with multiple sclerosis (MS) compared with the general population. We conducted a cross-sectional study including pregnancies from January 1, 1997, to December 31, 2016, to women registered in the Danish Multiple Sclerosis Registry (the study cohort). Pregnancy-related and perinatal outcomes were compared with a randomly selected subcohort of pregnancies from the general population (the comparison cohort) using logistic regression adjusted for possible confounders. In total, 2,930 pregnancies were included in the study cohort and 56,958 pregnancies in the comparison cohort. No differences were found in pregnancy-related complications (preeclampsia/gestational diabetes or placenta complications), emergency caesarean section (c-section), instrumental delivery, low Apgar score, stillbirth, preterm birth, or congenital malformations. Elective c-section (odds ratio [OR] 1.89 [95% confidence interval (CI) 1.65-2.16]), induced delivery (OR 1.15 [95% CI 1.01-1.31]), and being born small for gestational age (SGA) (OR 1.29 [95 %CI 1.04-1.60]) had a higher prevalence in the study cohort, whereas the prevalence of signs indicating asphyxia was lower in the study cohort (OR 0.87 [95% CI 0.78-0.97]) relative to the comparison cohort. We found a higher prevalence of elective c-sections, induced delivery, and infants being SGA among newborns to women with MS, whereas the prevalence of asphyxia was lower in the study cohort. There were no significant differences in severe adverse perinatal outcomes when comparing women with MS and their newborns with those of the general population.

305 A predictive index for severe adverse perinatal outcomes in pregnancies complicated by fetal growth restriction

Lack of significance of several covariates in a model we recently validated indicated model reconstruction may improve its performance. Our aim was to redevelop the model and then use it to develop an index predictive of severe adverse perinatal outcomes in pregnancies complicated by fetal growth restriction (FGR). Data was derived from a cohort of singleton non-anomalous gestations meeting Delphi procedure-based consensus criteria [Gordijn S et al. Ultrasound Obstet Gynecol 2016;48(3):333-9] for FGR between 2010-2020 at a single tertiary-care institution. The cohort was retrospectively analyzed according to the occurrence of composite adverse perinatal outcome: perinatal demise, 5-minute Apgar < 7, cord pH ≤ 7.1, or cord base excess ≥ 12. Regression analysis incorporated clinical factors widely available at the time of growth restriction diagnosis. The sum of beta coefficient-based weights yielded a severe adverse perinatal outcome index score. Of the 907 pregnancies that met criteria for FGR, 226 (25%) were complicated by severe adverse perinatal outcomes. 278 (31%) were delivered by cesarean for non-reassuring fetal status and 410 (45%) neonates were admitted to the NICU. The derived index included nine clinical factors: maternal age ≥ 30, body mass index ≥ 40, nulliparity, male fetus, gestational age ≤ 28 weeks, hypertensive disorder of pregnancy both with and without chronic hypertension, umbilical artery absent or reversed end diastolic flow, and gestational diabetes. The index’s bootstrapped bias-corrected AUC was 0.78 (95% CI 0.74-0.81). Index sum cut-points were selected to identify “high risk” (≥ 10) and “low risk” (≤ 4) ranges that have positive and negative predictive values of 73% (95% CI 63-81%) and 88% (95% CI 86-90%), respectively. An index incorporating nine clinical factors widely available at time of growth restriction diagnosis was predictive of severe adverse perinatal outcomes. If validated, the index may prove useful in counseling and management of pregnancies meeting consensus-based criteria for fetal growth restriction.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

304 Predicting severe adverse perinatal outcomes in pregnancies complicated by fetal growth restriction: a validation study

Validate a model predictive of severe adverse perinatal outcomes in pregnancies complicated by fetal growth restriction using clinical factors widely available at time of diagnosis. We assessed the performance of a 7-item model previously developed from 336 pregnancies (2013-2019) meeting Delphi procedure-based consensus criteria [Gordijn SJ et al. Ultrasound Obstet Gynecol 2016;48(3):333-9] for fetal growth restriction (FGR). The model assesses risk of composite severe adverse perinatal outcome: perinatal demise, 5-minute Apgar < 7, cord pH ≤ 7.1, or cord base excess > 12. It includes factors available at diagnosis: hypertensive disorder of pregnancy (HDP), gestational age ≤ 30 weeks, isolated abdominal circumference < 3rd centile, absent/reversed end diastolic flow (A/REDF), chronic hypertension, maternal height > 160 cm, and pre-gravid weight 68.5 kg. To validate the model, we retrospectively analyzed data from non-anomalous, singleton gestations (2010-2020) not included in model development. Severe adverse perinatal outcomes complicated 22% (127) of 585 pregnancies. In addition, there were 257 (45%) NICU admissions and 169 (29%) cesareans for non-reassuring fetal status. Women with the composite outcome were more likely to have a higher body mass index, hypertensive disorders, and abnormal umbilical artery flow. Model performance in the validation cohort [bias-corrected bootstrapped AUC of 0.76 (95% CI 0.69-0.79)], was similar to the development cohort [AUC of 0.81 (95% CI 0.73-0.84)]; however only HDP, A/REDF, and gestational age ≤ 30 weeks were significant. Performance was better for early-onset [n = 316, AUC 0.76 (95% CI 0.71-0.82)] compared to late-onset (n = 269) growth restriction [AUC 0.69 (95% CI 0.55-0.66)]. Performance of a model predictive of severe adverse perinatal outcome in a larger validation cohort was relatively strong. However, lack of significance of four covariates indicates model redevelopment may improve performance and, in doing so, its utility in counseling and management of pregnancies complicated by growth restriction.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

The first SARS-CoV-2 wave among pregnant women in Italy: results from a prospective population-based study.

This study aimed to estimate the incidence of SARS-CoV-2 infection among pregnant women during the first pandemic wave in Italy, and to describe COVID-19 disease characteristics and maternal and perinatal outcomes. National population-based prospective cohort study collecting information on women with SARS-CoV-2 diagnosis, confirmed within 7 days from hospital admission. The national SARS-CoV-2 rate was 6.04 per 1,000 births (95% CI 5.62-6.49) among pregnant women and 7.54 (95% CI 7.47-7.61) among women in reproductive age. 72.1% of the cohort developed mild COVID-19 disease without pneumonia nor need for ventilatory support. Severe disease was significantly associated with women's previous comorbidities (OR 2.55; 95% CI 0.98-6.90), obesity (OR 4.76; 95% CI 1.79-12.66) and citizenship from High Migration Pressure Countries (OR 3.43; 95% CI 1.27-9.25). During the first pandemic wave in Italy, the SARS-CoV-2 rate among pregnant women was lower compared to that detected among women of reproductive age, and risks of severe COVID-19 disease and adverse maternal and perinatal outcomes were rare.

998 Fetal growth restriction and the association between abnormal placental changes and significant adverse neonatal outcomes

To evaluate the frequency of abnormal placental changes and significant adverse neonatal outcomes in pregnancies complicated by fetal growth restriction (FGR) as defined by the Delphi procedure. We performed a retrospective cohort study of 423 singleton, non-anomalous pregnancies at a tertiary care center from 2010-2020 that met the diagnosis of fetal growth restriction by the Delphi procedure-based consensus and resulted in either intrauterine fetal demise, neonatal demise, or NICU admission. Cases for which the postnatal course was unknown or placenta pathology was not performed were excluded. Chi-square bivariate analysis was performed to evaluate the association between abnormal placental findings and severe adverse neonatal outcomes, which included grade III-IV intraventricular hemorrhage (IVH) or periventricular leukomalacia, necrotizing enterocolitis (NEC), sepsis, bronchopulmonary dysplasia, perinatal demise, as well as a composite of all outcomes. Severe adverse perinatal outcomes occurred in 168 (39.7%) pregnancies; 54 (32.1%) ended in demise. Placental pathology was available for 401 cases. Placenta-to-birthweight ratio was greater for cases with severe adverse outcomes (0.27 vs 0.21, p< .001). 171 (43%) placentas exhibited maternal lesions and 30 (7%) had fetal lesions. Villous changes were noted in all categories with the exception of NEC; vascular lesions were found in all categories except for NEC and IVH. Perinatal demise was the only factor associated with fetal malperfusion lesions. NEC was the only outcome not individually associated with any placental pathology. Cases of severe adverse neonatal outcomes were associated with abnormal placental pathology, most commonly malperfusion lesions. Our findings support the conclusion that severe FGR and significant adverse outcomes are associated with poor placental perfusion attributed to maternal vascular disease. Future study is needed to determine how chronic maternal vascular disorders may be used to guide prognostic discussions on the likelihood of adverse outcomes.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Anesthesia management in obstetric patients with positive COVID-19

The COVID-19 pandemic, is an ongoing pandemic caused by corona virus.It can lead to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).As of 9 March 2021, more than 117 million cases have been confirmed, with more than 2.6 million deaths attributed to COVID-19, making it one of the deadliest pandemics in history. As the pandemic evolves rapidly, there are data emerging to suggest that pregnant women diagnosed as having coronavirus disease 2019 can have severe morbidities (up to 9%). The aim of this article is to bring attention to all steps that should be followed in obstetric patients with positive COVID-19. This is a litterature review, refering to international guidelines and international collegues experiences , especially from Wuhan and USA. In contrast to earlier data that showed good maternal and neonatal outcomes, the latest data suggest that pregnant woman can have severe morbidities. Exposure to virus predisposes both mother and fetus to an increased risk of infection and severe adverse maternal and perinatal outcomes. The anesthesia management of the patient with a suspected or confirmed COVID-19 infection presents a major challenge for anesthesia professionals because of the pathophysiologic and confirmed rapid human-to- human transmission of the virus through symptomatic and asymptomatic carriers. As with SARS and MERS, the most critical goal in the OR is to prevent cross-contamination by implementing stringent anesthesia guidelines and infection control strategies in the perioperative setting. Pregnant women with suspected or confirmed COVID-19 should be triaged and their condition categorized as mild, severe, or critical. Asymptomatic and mild cases should be isolated at home, and be taken care throw all the process until the day of the delivery. Severe and MOF patients should be taken care in the hospital by a multidisciplinary group. Vaginal delivery is recommended in stable patients because viral shedding and vertical transmission have not been reported. There are international recommendations starting to continuous CTG monitoring due to possible increased risk of fetal distress, monitor temperature, respiratory rate. Under normal labor progression, vaginal examinations should be minimized. Neuraxial analgesia is not contraindicated, and by providing good analgesia, it may reduce cardiopulmonary stress from pain and anxiety. Although evidence of mother-to-child transmission is lacking, early cord clamping may be discussed with the patient. The patient could informedly decide skin-to-skin contact with the newborn , ensuring precautions for respiratory droplets with the use of a mask as well as hand and skin hygiene. Caesarean section should follow usual obstetric indications. The potential risk of vertical transmission is not an indication for caesarean section. Because of pulmonary complication known in COVID-19, the regional anesthesia is recommended unless there are no contraindication. Before neuraxial anesthesia must be done blood count test, especially to asses the platelet count. If general anesthesia is required , the anesthesia machine must be prepared with an HMEF between the circuit and the patient’s airway. The most experienced anesthesia provider should be dedicated to the intubation. The anesthetist should manage the pain, preferably with NSAIDS, the PONV using antiemetics and VTE prophylaxis. COVID-19 is highly contagious, and this must be taken into consideration when planning intrapartum care. Rational use of personal protective equipment is key in preventing infection in attending professionals. The first of all is ’’ Primum non nocere’’, it should be done the best for the pregnant patient and for the newborn protecting the personnel. There are still limited data on the care and management of the parturient with COVID-19. It is paramount that our profession shares our experiences and practices to help guide our multidisciplinary approach in delivering the best care possible to these women.

Induction of labour at 41 weeks or expectant management until 42 weeks: A systematic review and an individual participant data meta-analysis of randomised trials

The risk of perinatal death and severe neonatal morbidity increases gradually after 41 weeks of pregnancy. Several randomised controlled trials (RCTs) have assessed if induction of labour (IOL) in uncomplicated pregnancies at 41 weeks will improve perinatal outcomes. We performed an individual participant data meta-analysis (IPD-MA) on this subject. We searched PubMed, Excerpta Medica dataBASE (Embase), The Cochrane Library, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and PsycINFO on February 21, 2020 for RCTs comparing IOL at 41 weeks with expectant management until 42 weeks in women with uncomplicated pregnancies. Individual participant data (IPD) were sought from eligible RCTs. Primary outcome was a composite of severe adverse perinatal outcomes: mortality and severe neonatal morbidity. Additional outcomes included neonatal admission, mode of delivery, perineal lacerations, and postpartum haemorrhage. Prespecified subgroup analyses were conducted for parity (nulliparous/multiparous), maternal age (<35/≥35 years), and body mass index (BMI) (<30/≥30). Aggregate data meta-analysis (MA) was performed to include data from RCTs for which IPD was not available. From 89 full-text articles, we identified three eligible RCTs (n = 5,161), and two contributed with IPD (n = 4,561). Baseline characteristics were similar between the groups regarding age, parity, BMI, and higher level of education. IOL resulted overall in a decrease of severe adverse perinatal outcome (0.4% [10/2,281] versus 1.0% [23/2,280]; relative risk [RR] 0.43 [95% confidence interval [CI] 0.21 to 0.91], p-value 0.027, risk difference [RD] -57/10,000 [95% CI -106/10,000 to -8/10,000], I2 0%). The number needed to treat (NNT) was 175 (95% CI 94 to 1,267). Perinatal deaths occurred in one (<0.1%) versus eight (0.4%) pregnancies (Peto odds ratio [OR] 0.21 [95% CI 0.06 to 0.78], p-value 0.019, RD -31/10,000, [95% CI -56/10,000 to -5/10,000], I2 0%, NNT 326, [95% CI 177 to 2,014]) and admission to a neonatal care unit ≥4 days occurred in 1.1% (24/2,280) versus 1.9% (46/2,273), (RR 0.52 [95% CI 0.32 to 0.85], p-value 0.009, RD -97/10,000 [95% CI -169/10,000 to -26/10,000], I2 0%, NNT 103 [95% CI 59 to 385]). There was no difference in the rate of cesarean delivery (10.5% versus 10.7%; RR 0.98, [95% CI 0.83 to 1.16], p-value 0.81) nor in other important perinatal, delivery, and maternal outcomes. MA on aggregate data showed similar results. Prespecified subgroup analyses for the primary outcome showed a significant difference in the treatment effect (p = 0.01 for interaction) for parity, but not for maternal age or BMI. The risk of severe adverse perinatal outcome was decreased for nulliparous women in the IOL group (0.3% [4/1,219] versus 1.6% [20/1,264]; RR 0.20 [95% CI 0.07 to 0.60], p-value 0.004, RD -127/10,000, [95% CI -204/10,000 to -50/10,000], I2 0%, NNT 79 [95% CI 49 to 201]) but not for multiparous women (0.6% [6/1,219] versus 0.3% [3/1,264]; RR 1.59 [95% CI 0.15 to 17.30], p-value 0.35, RD 27/10,000, [95% CI -29/10,000 to 84/10,000], I2 55%). A limitation of this IPD-MA was the risk of overestimation of the effect on perinatal mortality due to early stopping of the largest included trial for safety reasons after the advice of the Data and Safety Monitoring Board. Furthermore, only two RCTs were eligible for the IPD-MA; thus, the possibility to assess severe adverse neonatal outcomes with few events was limited. In this study, we found that, overall, IOL at 41 weeks improved perinatal outcome compared with expectant management until 42 weeks without increasing the cesarean delivery rate. This benefit is shown only in nulliparous women, whereas for multiparous women, the incidence of mortality and morbidity was too low to demonstrate any effect. The magnitude of risk reduction of perinatal mortality remains uncertain. Women with pregnancies approaching 41 weeks should be informed on the risk differences according to parity so that they are able to make an informed choice for IOL at 41 weeks or expectant management until 42 weeks. Study Registration: PROSPERO CRD42020163174.

Effectiveness of Routine Third Trimester Ultrasonography to Reduce Adverse Perinatal Outcomes in Low-risk Pregnancy (the IRIS Study): Nationwide, Pragmatic, Multicentre, Stepped Wedge Cluster Randomized Trial

(BMJ. 2019;367:l5517) Fetal growth restriction affects 7% to 10% of pregnancies and is a major risk factor for perinatal morbidity and death, as well as cardiovascular disease in adulthood. Small for gestational age (SGA) infants can be detected during usual prenatal care with serial fundal height measurements. While routine ultrasonography during the third trimester more frequently detects SGA infants than usual prenatal care, there is a lack of evidence indicating this practice reduces the incidence of severe adverse perinatal outcomes. Previous studies on the subject have been underpowered or were not clearly linked with appropriate management practices following an SGA diagnosis. This Intrauterine growth restriction Risk Selection (IRIS) study developed a multidisciplinary protocol for detecting and managing suspected fetal growth restriction and used a stepped wedge cluster randomized design to evaluate the effectiveness of routine ultrasonography in the third trimester combined with usual care, compared with usual care alone, in decreasing severe adverse perinatal outcomes.

Insulin Dosing, Glycemic Control, and Perinatal Outcomes in Pregnancies Complicated by Type-2 Diabetes.

This study aimed to evaluate the prevalence of severe insulin resistance (insulin requirements ≥2 units/kg) at delivery and the relationship between severe insulin resistance, glycemic control, and adverse perinatal outcomes in pregnant women with type-2 diabetes mellitus. This is a retrospective cohort study of women with type-2 diabetes mellitus who delivered between January 2015 and December 2017 at a tertiary academic medical center. Maternal demographic information, self-monitored blood sugars, and insulin doses were abstracted from the medical record. Multivariable logistic regression was used to identify maternal baseline characteristics associated with severe insulin resistance at delivery. Overall 72/160 (45%) of women had severe insulin resistance. Women in the severe insulin resistance group demonstrated evidence of suboptimal glycemic control as evidenced by higher mean hemoglobin A1c (HbA1c) values (7.2 [ ± 1.1] vs. 6.6 [ ± 1.3%], p = 0.003), higher mean fasting (104.0 [ ± 17.4] vs. 95.2 [ ± 11.7 mg/dL], p < 0.001) and postprandial glucose values (132.4 [ ± 17.2] vs. 121.9 [ ± 16.9 mg/dL]), p < 0.001), and a higher percentage of total glucose values that were elevated above targets (37.7 [95% confidence interval (CI): 26.8-50] vs. 25.6 [95% CI: 13.3-41.3%], p < 0.001). Maternal HbA1c ≥6.5% and insulin use prior to pregnancy were associated with a higher prevalence of severe insulin resistance, while Hispanic ethnicity and non-White race were associated with a lower prevalence of severe insulin resistance. The rates of adverse perinatal outcomes including large for gestational age (LGA) birth weight, cesarean delivery, and hypertensive disorders of pregnancy did not differ between groups. Severe insulin resistance is common among pregnant women with type-2 diabetes, and it is associated with suboptimal glycemic control. Future studies are necessary to develop strategies to identify women with severe insulin resistance early in pregnancy and facilitate adequate insulin dosing. · Severe insulin resistance is common.. · BMI does not predict severe insulin resistance.. · Suboptimal glycemic control is common..

Reappraisal of the relationship between 24-hour proteinuria and preeclampsia in terms of the maternal and perinatal outcomes

ABSTRACT Objective This study evaluated the association between proteinuria levels and maternal, and perinatal outcomes of preeclampsia patients and determined the cutoff values for predicting severe complications. Methods We retrospectively evaluated the records of 412 patients with proteinuric preeclampsia. Results Median proteinuria levels were significantly higher in patients with severe maternal and adverse perinatal outcomes than in those without such outcomes, except in cases of placental abruption and late preterm delivery. Conclusion Proteinuria levels may aid in diagnosing preeclampsia and indicating early intervention. The revised guidelines do not suggest that proteinuria encountered during pregnancy is clinically insignificant.

Prediction of preterm birth and adverse perinatal outcomes after cervical pessary placement in singleton pregnancies with short cervical length

Objectives To identify ultrasound-assessed cervical characteristics, modified after pessary placement, which could be predictive of spontaneous preterm birth (sPTB) at < 34 weeks of gestation (WG) or severe adverse perinatal outcomes (APO). Study design This prospective observational study conducted at Vall d’Hebron Universitary Hospital assessed multiple cervical characteristics in women with short cervical length (CL). All participants were examined by transvaginal ultrasound before and immediately after a cervical pessary was placed. Cervical assessment included CL, uterocervical angles (UCA), and cervical consistency indexes (cervical consistency index (CCI) and cervical length consistency index (CLCI)). Pregnancy outcomes were recorded to determine the capacity of these variables for predicting sPTB at < 34 WG and severe APO. Results Thirty-one women with short CL, 17 (54.8%) with asymptomatic midtrimester short CL, and 14 (45.2%) after arrested threatened preterm labor were enrolled. After pessary placement, transvaginal ultrasound detected four participants in whom the pessary was not correctly placed around the cervix (12.9%); additionally, significant changes were observed in most cervical baseline characteristics, with CL, anterior UCA (A-UCA), CLCI, and intersegmentary angle (ISA) being predictive of sPTB at <34 WG and severe APO. Receiver operator curves were calculated to compare the predictive capacity of these variables, with CL and A-UCA after pessary placement being the best predictive parameters with an area under the curve of 0.88 and 0.87, respectively. Conclusions Transvaginal ultrasound after pessary placement detects incorrect pessary placement after pessary insertion and during follow-up. APO and sPTB can be predicted by measuring CL, A-UCA, CLCI, and ISA immediately after pessary placement, being CL and A-UCA more accurate and easier to be measured. Our results help to better identify women in whom the pessary is more likely to fail. Further research is required to assess the effectiveness of applying alternative, sequential or additional treatments to reduce prematurity and our results could be considered when designing such studies.

Trauma in pregnancy and severe adverse perinatal outcomes

Background Trauma, including accidental and violent trauma, is a rare but severe complication of pregnancy. The incidence of adverse perinatal outcomes in pregnancies affected by traumatic injury has not been well-studied. Objective We sought to characterize the association between traumatic injury during pregnancy and severe adverse perinatal outcomes in a large population. Study design We performed a retrospective cohort study of California Birth Registry data from 2007 to 2011. ICD-9 diagnosis and procedure codes were used to categorize patients into trauma and non-trauma cohorts and to assess the prevalence of severe adverse fetal and neonatal outcomes. Chi-square tests were used to characterize maternal demographics and perform univariate analyses, and logistic regression was used to control for potential confounders. Results Of 2,406,605 singleton nonanomalous pregnancies, 1262 (0.05%) experienced trauma prior to delivery. The rate of composite perinatal outcomes was higher in pregnancies with trauma compared to those without (3.1 versus 0.87%, p < .001). Trauma was associated with higher occurrences of preterm birth <37 weeks, preterm birth <32 weeks, very low birth weight and neonatal death. Fetal demise at any gestational age was more common among trauma patients (1.9 versus 0.53%, p < .001), though this difference was not statistically significant among term fetuses (0.28 versus 0.14%, p = .21). A difference in composite adverse perinatal outcomes was seen even after controlling for important maternal characteristics (aOR 3.2, 95% CI). Trauma patients with severe morbidity compared to those without had higher rates of preterm birth <37 weeks, preterm birth <32 weeks, and composite severe perinatal outcomes. Conclusion Trauma in pregnant women is associated with an increased risk of severe adverse perinatal outcomes, including fetal and neonatal demise. Prevalence of fetal demise is not different between trauma and non-trauma mothers when looking at term fetuses only, suggesting that the greatest risk of fetal demise in the setting of trauma occurs in the preterm period. These data can be used to counsel patients and to inform more detailed research into the mechanisms of trauma in pregnancy outcomes.

Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial

ObjectivesTo 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...

Outcome of small for gestational age-fetuses in breech presentation at term according to mode of delivery: a nationwide, population-based record linkage study.

To evaluate whether a trial of planned vaginal labor is associated with adverse perinatal outcome in singleton, small for gestational agefetuses in breech presentation at term. This is a Finnish nationwide, population-based record linkage study. The studied population included all small for gestational age breech labors from January 1, 2004 to December 31, 2014. "Small for gestational age" was defined as birth weight below the 10th percentile according to gestational age. An odds ratio with 95% confidence intervals was used to estimate the relative risk for perinatal mortality and morbidity in a trial of vaginal labor. The reference group included all small for gestational age infants born in breech presentation by planned cesarean section. During the study period of eleven years, 1841 small for gestational age infants were delivered in breech position at term. A trial of vaginal breech labor is associated with a higher rate of neonates with an umbilical pH below seven [odds ratio 7.82 (1-61.21)], a lower 5-min Apgar score <7 [adjusted odds ratio 6.39 (1.43-28.46)] and <4 [adjusted odds ratio 6.39 (1.43-28.46)], a higher rate of postpartum neonatal intubations [adjusted odds ratio 6.52 (1.93-22)], an increased rate of neonatal antibiotic therapy [adjusted odds ratio 3.31 (1.85-5.93)], and with a higher rate of combined severe adverse perinatal outcome [adjusted odds ratio 4.24 (1.43-12.61)]. A trial of vaginal breech labor in SGA fetuses is associated with adverse perinatal outcome and should be avoided.

OC10.03: Prediction of small‐for‐gestational age with severe adverse perinatal outcome or neonatal morbidity at term

OC10.03: Prediction of small‐for‐gestational age with severe adverse perinatal outcome or neonatal morbidity at term

Perinatal mortality or severe neonatal encephalopathy among normally formed singleton pregnancies according to obstetric risk status:” is low risk the new high risk?” A population-based cohort study

ObjectiveTo evaluate the capacity of the current system of obstetric risk stratification at the outset of pregnancy to predict severe adverse perinatal outcome. Study DesignThis retrospective cohort study of singleton pregnancies over a five year period (2009–2013) was performed at the Rotunda Hospital, Dublin, Ireland. High-risk or low-risk status was assigned retrospectively to a large consecutive cohort of women with a normally-formed singleton pregnancy on the basis of factors analyzed at the first prenatal hospital visit. The incidence of severe perinatal morbidity and mortality were compared between high- and low-risk groups to determine the predictive utility of risk stratification at the outset of pregnancy for severe perinatal morbidity. ResultsDuring the study period, 41,044 patients registered for prenatal care. 25,702;(63%) were deemed low-risk and 15,342;(37%) high-risk. Low-risk women were statistically more likely to be nulliparous (p < 0.0001) and to have a spontaneous or operative vaginal delivery (p < 0.0001). High-risk women were more likely to be multiparous and to undergo Caesarean delivery (p < 0.0001). The perinatal mortality rate was 3.8 per-1000 in low-risk pregnancies and 6.1 per-1000 in the a priori high-risk group (p = 0.012). The incidence of severe neonatal encephalopathy (NNE) was 1.8 and 0.65 per-1000 in the low and high-risk groups respectively (p = 0.0025). ConclusionWhere low-risk status is assigned at registration, neonatal encephalopathy is more prevalent. This data is relevant for the design of prenatal care models and demonstrates that assignment of low obstetric risk on the basis of maternal or pre-pregnancy factors alone may erroneously be interpreted as conferring low-risk status to the fetus.

Early-onset Preeclampsia in Lupus Pregnancy.

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that occurs during childbearing years and has been associated with preeclampsia. However, little is known about preeclampsia of early onset, which is associated with severe adverse maternal and perinatal outcomes. Using national population-based Swedish registers we identified women with SLE (≥2 visits with corresponding ICD codes) and a sample without SLE who gave birth to singleton infants 2001-12. Risk ratios (RR) and 95% confidence intervals (CI) for early-onset preeclampsia (defined by ICD codes corresponding to preeclampsia registered at <34 weeks) in SLE women were calculated based on adjusted modified Poisson models for first, subsequent, and all pregnancies. Among 742 births to women with SLE and 10 484 births to non-SLE women, there were 32 (4.3%) and 55 (0.5%) diagnoses of early-onset preeclampsia respectively. SLE was associated with an increased risk of early-onset preeclampsia (RR 7.8, 95% CI 4.8, 12.9, all pregnancies). The association remained similar upon restriction to women without pregestational hypertension. Adjustment for antiphospholipid syndrome (APS)-proxy attenuated the association. RRs for early-onset preeclampsia were smaller for subsequent pregnancies (RR 4.7, 95% CI 2.0, 11.2) compared to first and all (see above). Women with SLE are at increased risk of early-onset preeclampsia and this increased risk may be independent of the traditional risk factors such as pregestational hypertension, APS, BMI, or smoking. Women with SLE during pregnancy should be closely monitored for early-onset preeclampsia and future research needs to identify the non-traditional preeclampsia factors that might cause this serious outcome.

Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study)

BackgroundIntrauterine growth retardation (IUGR) is a major risk factor for perinatal mortality and morbidity. Thus, there is a compelling need to introduce sensitive measures to detect IUGR fetuses. Routine third trimester ultrasonography is increasingly used to detect IUGR. However, we lack evidence for its clinical effectiveness and cost-effectiveness and information on ethical considerations of additional third trimester ultrasonography. This nationwide stepped wedge cluster-randomized trial examines the (cost-)effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcome through subsequent protocolized management.MethodsFor this trial, 15,000 women with a singleton pregnancy receiving care in 60 participating primary care midwifery practices will be included at 22 weeks of gestation. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. All practices will start offering the control condition (ultrasonography based on medical indication). Every three months, 20 practices will be randomized to the intervention condition, i.e. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28–30 weeks and 34–36 weeks). If IUGR is suspected, both groups will receive subsequent clinical management as described in the IRIS study protocol that will be developed before the start of the trial.The primary dichotomous clinical composite outcome is ‘severe adverse perinatal outcome’ up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. For the economic evaluation, costs will be measured from a societal perspective. Quality of life will be measured using the EQ-5D-5 L to enable calculation of QALYs. Cost-effectiveness and cost-utility analyses will be performed. In a qualitative sub-study (using diary notes from 32 women for 9 months, at least 10 individual interviews and 2 focus group studies) we will explore ethical considerations of additional ultrasonography and how to deal with them.DiscussionThe results of this trial will assist healthcare providers and policymakers in making an evidence-based decision about whether or not introducing routine third trimester ultrasonography.Trial registration NTR4367, 21 March 2014.