Fetal, Infant and Maternal Outcomes among Women with Prolapsed Membranes Admitted before 29 Weeks Gestation.
ABSTRACT: Few studies have examined fetal, infant and maternal mortality and morbidity among pregnant women at very early gestation with an open cervix and prolapsed membranes. We carried out a study describing the outcomes of women hospitalized with prolapsed membranes at 22-28 weeks' gestation.We prospectively recruited women with singleton pregnancies admitted at 22-28 weeks' gestation to tertiary hospitals of the Canadian Perinatal Network between 2005 and 2009. Time-to-delivery, perinatal death, neonatal intensive care unit (NICU) admission, severe neonatal morbidity and severe maternal morbidity were compared between women admitted at 22-25 vs. 26-28 weeks gestation. Logistic regression was used to estimate adjusted odds ratios (AOR) and 95% confidence intervals.129 women at 22-25 weeks gestation and 65 women at 26-28 weeks gestation were admitted to hospital and the median time-to-delivery was 4 days in both groups. Stillbirth rates were 12.4% vs 4.6% among women admitted at earlier vs later gestation (AOR 2.8, 95% CI 0.5-14.8), while perinatal death rates were 38.0% vs 6.1% (AOR 14.1, 95% CI 3.5-59.0), respectively. There were no significant differences in NICU admission and severe morbidity among live-born infants; 89.4% and 82.3% died or were admitted to NICU, (P value 0.18), and 53.9% vs 44.0% of NICU infants had severe neonatal morbidity (P value 0.28). Antibiotics, tocolysis and cerclage did not have a significant effect on perinatal death. Maternal death or severe maternal morbidity occurred in 8.5% and 6.2% of women admitted at 22-25 vs 26-28 weeks (AOR 1.2, 95% CI 0.4-4.2).Perinatal mortality among women with prolapsed membranes at very early gestation is high, although significantly lower among those admitted at a relatively later gestational age. Rates of adverse maternal outcomes are also high. This information can be used to counsel women with prolapsed membranes at 22 to 28 weeks gestation.
Project description:The efficacy of antenatal corticosteroid treatment for women with threatened preterm birth depends on timely administration within 7 days before delivery. We modelled the probability of delivery within 7 days of admission to hospital among women presenting with threatened preterm birth, using routinely collected clinical characteristics.Data from the Canadian Perinatal Network (CPN) were used, 2005-11, including women admitted to hospital with preterm labour, preterm pre-labour rupture of membranes, short cervix without contractions, or dilated cervix or prolapsed membranes without contractions at preterm gestation. Women with fetal anomaly, intrauterine fetal demise, twin-to-twin transfusion syndrome, and quadruplets were excluded. Logistic regression was undertaken to create a predictive model that was assessed for its calibration capacity, stratification ability, and classification accuracy (ROC curve).We included 3012 women admitted at 24-28 weeks gestation, or readmitted at up to 34 weeks gestation, to 16 tertiary-care CPN hospitals. Of these, 1473 (48.9%) delivered within 7 days of admission. Significant predictors of early delivery included maternal age, parity, gestational age at admission, smoking, preterm labour, prolapsed membranes, preterm pre-labour rupture of membranes, and antepartum haemorrhage. The area under the ROC curve was 0.724 (95% CI 0.706-0.742).We propose a useful tool to improve prediction of delivery within 7 days after admission among women with threatened preterm birth. This information is important for optimal corticosteroid treatment.
Project description:INTRODUCTION:The objective was to evaluate the association between fetal sex and adverse pregnancy outcome, while correcting for fetal growth and gestational age at delivery. MATERIAL AND METHODS:Data from the Netherlands Perinatal Registry (1999-2010) were used. The study population comprised all white European women with a singleton delivery between 25+0 and 42+6 weeks of gestation. Fetuses with structural or chromosomal abnormalities were excluded. Outcomes were antepartum death, intrapartum/neonatal death (from onset of labor until 28 days after birth), perinatal death (antepartum death or intrapartum/neonatal death), a composite of neonatal morbidity (including infant respiratory distress syndrome, sepsis, necrotizing enterocolitis, meconium aspiration, persistent pulmonary hypertension of the newborn, periventricular leukomalacia, Apgar score <7 at 5 minutes, and intracranial hemorrhage) and a composite adverse neonatal outcome (perinatal death or neonatal morbidity). Outcomes were expressed stratified by birthweight percentile (<p10 [small for gestation], p10-90 [normal weight], >p90 [large for gestation]) and gestational age at delivery (25+0 -27+6 , 28+0 -31+6 , 32+0 -36+6 , 37+0 -42+6 weeks). The association between fetal sex and outcome was assessed using the fetus at risk approach. RESULTS:We studied 1 742 831 pregnant women. We found no increased risk of antepartum, intrapartum/neonatal and perinatal death in normal weight and large-for-gestation males born after 28+0 weeks compared with females. We found an increased risk of antepartum death among small-for-gestation males born after 28+0 weeks (relative risk [RR] 1.16-1.40). All males born after 32+0 weeks of gestation suffered more neonatal morbidity than females regardless of birthweight percentile (RR 1.07-1.34). Infant respiratory distress syndrome, sepsis, persistent pulmonary hypertension of the newborn, Apgar score <7 at 5 minutes, and intracranial hemorrhage all occurred more often in males than in females. CONCLUSIONS:Small-for-gestation males have an increased risk of antepartum death and all males born after 32+0 weeks of gestation have an increased risk of neonatal morbidity compared with females. In contrast to findings in previous studies we found no increased risk of antepartum, intrapartum/neonatal or perinatal death in normal weight and large-for-gestation males born after 28+0 weeks.
Project description:OBJECTIVE:To compare induction of labour at 41 weeks with expectant management until 42 weeks in low risk women. DESIGN:Open label, randomised controlled non-inferiority trial. SETTING:123 primary care midwifery practices and 45 hospitals (secondary care) in the Netherlands, 2012-16. PARTICIPANTS:1801 low risk women with an uncomplicated singleton pregnancy: randomised to induction (n=900) or to expectant management until 42 weeks (n=901). INTERVENTIONS:Induction at 41 weeks or expectant management until 42 weeks with induction if necessary. PRIMARY OUTCOME MEASURES:Primary outcome was a composite of perinatal mortality and neonatal morbidity (Apgar score <7 at five minutes, arterial pH <7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial haemorrhage, and admission to a neonatal intensive care unit (NICU). Secondary outcomes included maternal outcomes and mode of delivery. The null hypothesis that expectant management is inferior to induction was tested with a non-inferiority margin of 2%. RESULTS:Median gestational age at delivery was 41 weeks+0 days (interquartile range 41 weeks+0 days-41 weeks+1 day) for the induction group and 41 weeks+2 days (41 weeks+0 days-41 weeks+5 days) for the expectant management group. The primary outcome was analysed for both the intention-to-treat population and the per protocol population. In the induction group, 15/900 (1.7%) women had an adverse perinatal outcome versus 28/901 (3.1%) in the expectant management group (absolute risk difference -1.4%, 95% confidence interval -2.9% to 0.0%, P=0.22 for non-inferiority). 11 (1.2%) infants in the induction group and 23 (2.6%) in the expectant management group had an Apgar score <7 at five minutes (relative risk (RR) 0.48, 95% CI 0.23 to 0.98). No infants in the induction group and three (0.3%) in the expectant management group had an Apgar score <4 at five minutes. One fetal death (0.1%) occurred in the induction group and two (0.2%) in the expectant management group. No neonatal deaths occurred. 3 (0.3%) neonates in the induction group versus 8 (0.9%) in the expectant management group were admitted to an NICU (RR 0.38, 95% CI 0.10 to 1.41). No significant difference was found in composite adverse maternal outcomes (induction n=122 (13.6%) v expectant management n=102 (11.3%)) or in caesarean section rate (both groups n=97 (10.8%)). CONCLUSIONS:This study could not show non-inferiority of expectant management compared with induction of labour in women with uncomplicated pregnancies at 41 weeks; instead a significant difference of 1.4% was found for risk of adverse perinatal outcomes in favour of induction, although the chances of a good perinatal outcome were high with both strategies and the incidence of perinatal mortality, Apgar score <4 at five minutes, and NICU admission low. TRIAL REGISTRATION:Netherlands Trial Register NTR3431.
Project description:BackgroundPerinatal decision-making affects outcomes for extremely preterm babies (22–26 weeks’ gestational age (GA)): more active units have improved survival without increased morbidity. We hypothesised such units may gain skills and expertise meaning babies at higher gestational ages have better outcomes than if they were born elsewhere. We examined mortality and morbidity outcomes at age two for babies born at 27–28 weeks’ GA in relation to the intensity of perinatal care provided to extremely preterm babies.MethodsFetuses from the 2011 French national prospective EPIPAGE-2 cohort, alive at maternal admission to a level 3 hospital and delivered at 27–28 weeks’ GA, were included. Morbidity-free survival (survival without sensorimotor (blindness, deafness or cerebral palsy) disability) and overall survival at age two were examined. Sensorimotor disability and Ages and Stages Questionnaire (ASQ) result below threshold among survivors were secondary outcomes. Perinatal care intensity level was based on birth hospital, grouped using the ratio of 24–25 weeks’ GA babies admitted to neonatal intensive care to fetuses of the same gestation alive at maternal admission. Sensitivity analyses used ratios based upon antenatal steroids, Caesarean section, and newborn resuscitation. Multiple imputation was used for missing data; hierarchical logistic regression accounted for births nested within centres.Results633 of 747 fetuses (84.7%) born at 27–28 weeks’ GA survived to age two. There were no differences in survival or morbidity-free survival: respectively, fully adjusted odds ratios were 0.96 (95% CI: 0.54 to 1.71) and 1.09 (95% CI: 0.59 to 2.01) in medium and 1.12 (95% CI: 0.63 to 2.00) and 1.16 (95% CI: 0.62 to 2.16) in high compared to low-intensity hospitals. Among survivors, there were no differences in sensorimotor disability or ASQ below threshold. Sensitivity analyses were consistent with the main results.ConclusionsNo difference was seen in survival or morbidity-free survival at two years of age among fetuses alive at maternal hospital admission born at 27–28 weeks’ GA, or in sensorimotor disability or presence of an ASQ below threshold among survivors. There is no evidence for an impact of intensity of perinatal care for extremely preterm babies on births at a higher gestational age.
Project description:BACKGROUND:There is conflicting evidence about the role of oral magnesium supplementation in the prevention of preterm birth and related adverse outcomes. The objective of this study was to compare magnesium citrate with placebo in the prevention of adverse perinatal and maternal outcomes among women at higher risk. METHODS:This multicenter, double-masked, placebo-controlled randomized superiority clinical trial compared oral magnesium citrate 300?mg to matched placebo, from 12 to 20?weeks' gestation until delivery. This trial was completed in three centers in northeastern Brazil. Eligible women were those with a singleton pregnancy and???1 risk factor, such as prior preterm birth or preeclampsia, or current chronic hypertension or pre-pregnancy diabetes mellitus, age?>?35?years or elevated body mass index. The primary perinatal composite outcome comprised preterm birth?<?37?weeks' gestation, stillbirth?>?20?weeks, neonatal death?or NICU admission <?28?days after birth, or small for gestational age birthweight <?3rd percentile. The co-primary maternal composite outcome comprised preeclampsia or eclampsia?<?37?weeks, severe gestational hypertension?<?37?weeks, placental abruption, or maternal stroke or death during pregnancy or???7?days after delivery. RESULTS:Analyses comprised 407 women who received magnesium citrate and 422 who received placebo. The perinatal composite outcome occurred among 75 (18.4%) in the magnesium arm and 76 (18.0%) in the placebo group - an adjusted odds ratio (aOR) of 1.10 (95% CI 0.72-1.68). The maternal composite outcome occurred among 49 (12.0%) women in the magnesium arm and 41 women (9.7%) in the placebo group - an aOR of 1.29 (95% CI 0.83-2.00). CONCLUSIONS:Oral magnesium citrate supplementation did not appear to reduce adverse perinatal or maternal outcomes in high-risk singleton pregnancies. TRIAL REGISTRATION:ClinicalTrials.gov NCT02032186, registered January 9, 2014.
Project description:Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments.The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs.This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples.Trial registration number: NTR 4414 . Date of registration January 29th 2014.
Project description:<h4>Background</h4>Maternal asthma is associated with serious pregnancy complications, but newborn morbidity is understudied.<h4>Objective</h4>We wanted to determine whether infants of asthmatic mothers have more neonatal complications.<h4>Methods</h4>The Consortium on Safe Labor (2002-2008), a retrospective cohort, included 223,512 singleton deliveries at ? 23 weeks' gestation. Newborns of mothers with asthma (n = 17,044) were compared with newborns of women without asthma by using logistic regression models with generalized estimating equations to calculate adjusted odds ratios (ORs) and 95% CIs. Electronic medical record data included gestational week at delivery, birth weight, resuscitation, neonatal intensive care unit (NICU) admission, NICU length of stay, hyperbilirubinemia, respiratory distress syndrome, apnea, sepsis, anemia, transient tachypnea of the newborn, infective pneumonia, asphyxia, intracerebral hemorrhage, seizure, cardiomyopathy, periventricular or intraventricular hemorrhage, necrotizing enterocolitis, aspiration, retinopathy of prematurity, and perinatal mortality.<h4>Results</h4>Preterm delivery was associated with maternal asthma for each week after 33 completed weeks of gestation and not earlier. Maternal asthma also increased the adjusted odds of small for gestational age (OR = 1.10; 95% CI, 1.05-1.16), NICU admission (OR = 1.12; 95% CI, 1.07-1.17), hyperbilirubinemia (OR = 1.09; 95% CI, 1.04-1.14), respiratory distress syndrome (OR = 1.09; 95% CI, 1.01-1.19), transient tachypnea of the newborn (OR = 1.10; 95% CI, 1.02-1.19), and asphyxia (OR = 1.34; 95% CI, 1.03-1.75). Findings persisted for term infants (? 37 weeks) who had additional increased odds of intracerebral hemorrhage (OR = 1.84; 95% CI, 1.11-3.03) and anemia (OR = 1.30; 95% CI, 1.04-1.62).<h4>Conclusions</h4>Maternal asthma was associated with prematurity and small for gestational age. Adverse neonatal outcomes, including respiratory complications, hyperbilirubinemia, and NICU admission, were increased in association with maternal asthma even among term deliveries.
Project description:To describe the epidemiology of 2009 A/H1N1 influenza in critically ill pregnant women.Population based cohort study.All intensive care units in Australia and New Zealand.All women with 2009 H1N1 influenza who were pregnant or recently post partum and admitted to an intensive care unit in Australia or New Zealand between 1 June and 31 August 2009.Maternal and neonatal mortality and morbidity.64 pregnant or postpartum women admitted to an intensive care unit had confirmed 2009 H1N1 influenza. Compared with non-pregnant women of childbearing age, pregnant or postpartum women with 2009 H1N1 influenza were at increased risk of admission to an intensive care unit (relative risk 7.4, 95% confidence interval 5.5 to 10.0). This risk was 13-fold greater (13.2, 9.6 to 18.3) for women at 20 or more weeks' gestation. At the time of admission to an intensive care unit, 22 women (34%) were post partum and two had miscarried. 14 women (22%) gave birth during their stay in intensive care and 26 (41%) were discharged from an intensive care unit with ongoing pregnancy. All subsequently delivered. 44 women (69%) were mechanically ventilated. Of these, nine (14%) were treated with extracorporeal membrane oxygenation. Seven women (11%) died. Of 60 births after 20 weeks' gestation, four were stillbirths and three were infant deaths. 22 (39%) of the liveborn babies were preterm and 32 (57%) were admitted to a neonatal intensive care unit. Of 20 babies tested, two were positive for the 2009 H1N1 virus.Pregnancy is a risk factor for critical illness related to 2009 H1N1 influenza, which causes maternal and neonatal morbidity and mortality.
Project description:Introduction: Rates for caesarean section are on the rise and the reasons for this are being discussed worldwide. As the data is unclear, the identification of additional predictive factors for caesarean section is important as caesarean sections are closely linked to maternal and neonatal morbidity. The aim of the study was to identify predictive factors for the transfer of the neonate to a neonatal intensive care unit (NICU) depending on the mode of delivery. The study investigated the neonatal transfer rates for singleton and twin pregnancies delivered at ??36?+?0 weeks of gestation. Material and Methods: The data of all singleton (n?=?4181) and twin pregnancies (n?=?305 neonates), delivered between 1 January 2009 and 31 March 2012 in the OB/Gyn Department of the University Hospital Frankfurt/M, Germany, (perinatal center level 1) were evaluated. The indications for transfer to the NICU and possible predictive factors were evaluated. Results: Our study found a two times lower neonatal transfer rate for vaginal deliveries of pregnant women without risk factors compared to women with risk factors. The following neonatal transfer rates to the NICU were noted for singleton pregnancies: 4.7?% without risk factors, 8.3?% high-risk pregnancy, 6.2?% vaginal breech delivery, 9.3?% forceps delivery, 10?% elective primary caesarean section and 14?% secondary caesarean section. There was a statistically signific.
Project description:Objective:To determine whether there is a relationship between abnormal umbilical artery Doppler studies (UADS) and small for gestational age (SGA) birth weight and other adverse perinatal outcomes in fetuses that appear normally grown by ultrasound. Methods:This was a retrospective study of all women who had UADS performed at or after 26?weeks of gestation at our institution between January 2005 and December 2012. Women were excluded if they had a fetal demise, a fetus with growth restriction, a fetus with congenital anomaly, or a multiple gestation. Women with missing delivery outcomes were excluded. The primary outcome was birth weight below the 10th percentile. Results:There were 2744 women included in the study. Of those, 98 (3.6%) had an abnormal UADS, and 379 (13.8%) had an SGA neonate. Of the 2646 women who had a normal UADS, 353 (13.3%) women had an SGA neonate. Twenty-six (26.5%) of the 98 women who had an abnormal UADS had an SGA neonate. After adjusting for potential confounders, the adjusted odds ratio for an SGA neonate with an abnormal UADS was 2.2 (95% CI, 1.38-3.58; p?<? 0.05). In examining other adverse perinatal outcomes, neonatal intensive care unit (NICU) admission and low 5-min Apgar scores were 12.4 and 2.3%, respectively. The adjusted odds ratio for NICU admission was 1.84 (95% CI, 1.06-3.21; p?<? 0.05). Abnormal UADS was not associated with low Apgar scores (aOR 1.39: 95% CI 0.47-4.07; p?>?0.05). Conclusions:Our data suggest that abnormal UADS in fetuses that appear normally grown by ultrasound are associated with SGA neonates and NICU admission.