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The aim of this study was to test whether women who conceived after a period of subfertility are less likely to undergo invasive prenatal testing (IPT) and determine factors of influence in that decision. We conducted a retrospective study at the Maastricht University Medical Centre (MUMC+) to compare the rates of IPT following abnormal results of combined first trimester screening (cFTS) or second trimester screening (STS), or because of advanced maternal age among women tested for the effect of type and duration of subfertility and history of fertility investigations and/or treatment. We included 977 women who underwent IPT between January 2010 and December 2013. The women who conceived after fertility investigations and/or treatment had lower rates of IPT following abnormal STS (12.6% vs. 20.0%, OR = 0.58, 95% CI; 0.34-0.97). The difference was not statistically significant after correction for maternal age and severity of the foetal anomaly. Maternal age was, in contrast to fertility treatment or duration of subfertility, related to the choice of IPT among formerly subfertile women. Therefore, the lower uptake of IPT in women conceiving after a period of subfertility is dependent on the indication for IPT and maternal age and less on the type and duration of subfertility.
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Diagnóstico Prenatal/métodos , Técnicas Reproductivas Asistidas , Adulto , Femenino , Humanos , Oportunidad Relativa , EmbarazoRESUMEN
OBJECTIVE: To develop a prediction model of postnatal renal function in fetuses with lower urinary tract obstruction (LUTO) based on fetal ultrasound parameters and amniotic fluid volume. METHODS: Retrospective nationwide cohort study of fetuses with postnatally confirmed LUTO and known eGFR. Fetuses treated with fetal interventions such as vesico-amniotic shunting or cystoscopy were excluded. Logistic regression analysis was used to identify prognostic ultrasound variables with respect to renal outcome following multiple imputation of missing data. On the basis of these fetal renal parameters and amniotic fluid volume, a model was developed to predict postnatal renal function in fetuses with LUTO. The main study outcome was an eGFR less than 60 mL/min * 1.73 m2 based on the creatinine nadir during the first year following diagnosis. Model performance was evaluated by receiver operator characteristic (ROC) curve analysis, calibration plots, and bootstrapping. RESULTS: Hundred one fetuses with a confirmed diagnosis of LUTO were included, eGFR less than 60 was observed in 40 (39.6%) of them. Variables predicting an eGFR less than 60 mL/min * 1.73m2 included the following sonographic parameters: hyperechogenicity of the renal cortex and abnormal amniotic fluid volume. The model showed fair discrimination, with an area under the ROC curve of 0.70 (95% confidence interval, 0.59-0.81, 0.66 after bootstrapping) and was overall well-calibrated. CONCLUSION: This study shows that a prediction model incorporating ultrasound parameters such as cortical appearance and abnormal amniotic fluid volume can fairly discriminate an eGFR above or below 60 mL/min * 1.73m2 . This clinical information can be used in identifying fetuses eligible for prenatal interventions and improve counseling of parents.
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Tasa de Filtración Glomerular , Riñón/fisiopatología , Modelos Estadísticos , Anomalías Urogenitales/fisiopatología , Líquido Amniótico , Niño , Preescolar , Femenino , Humanos , Riñón/diagnóstico por imagen , Modelos Logísticos , Masculino , Ultrasonografía Prenatal , Anomalías Urogenitales/diagnóstico por imagenRESUMEN
OBJECTIVE: To assess the effectiveness of amnioinfusion in women with second-trimester preterm prelabor rupture of membranes. METHODS: We performed a nationwide, multicenter, open-label, randomized controlled trial, the PPROM: Expectant Management versus Induction of Labor-III (PPROMEXIL-III) trial, in women with singleton pregnancies and preterm prelabor rupture of membranes at 16 0/7 to 24 0/7 weeks of gestation with oligohydramnios (single deepest pocket less than 20 mm). Participants were allocated to transabdominal amnioinfusion or no intervention in a one-to-one ratio by a web-based system. If the single deepest pocket was less than 20 mm on follow-up visits, amnioinfusion was repeated weekly until 28 0/7 weeks of gestation. The primary outcome was perinatal mortality. We needed 56 women to show a reduction in perinatal mortality from 70% to 35% (ß error 0.20, two-sided α error 0.05). RESULTS: Between June 15, 2012, and January 13, 2016, we randomized 28 women to amnioinfusion and 28 to no intervention. One woman was enrolled before the trial registration date (June 19, 2012). Perinatal mortality rates were 18 of 28 (64%) in the amnioinfusion group vs 21 of 28 (75%) in the no intervention group (relative risk 0.86, 95% CI 0.60-1.22, P=.39). CONCLUSION: In women with second-trimester preterm prelabor rupture of membranes and oligohydramnios, we found no reduction in perinatal mortality after amnioinfusion. CLINICAL TRIAL REGISTRATION: NTR Dutch Trial Register, NTR3492.
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Líquido Amniótico , Rotura Prematura de Membranas Fetales/terapia , Oligohidramnios/terapia , Adulto , Femenino , Rotura Prematura de Membranas Fetales/mortalidad , Edad Gestacional , Humanos , Recién Nacido , Infusiones Parenterales , Países Bajos , Oligohidramnios/mortalidad , Atención Perinatal , Embarazo , Resultado del Embarazo , Segundo Trimestre del Embarazo , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
OBJECTIVE: To investigate the best criteria for discriminating fetuses with isolated posterior urethral valves from those theoretically not eligible for fetal treatment because of complex megacystis, high chance of spontaneous resolution, and urethral atresia. METHODS: A retrospective national study was conducted in fetuses with megacystis detected before 17 weeks' gestation (early megacystis). RESULTS: In total, 142 cases with fetal megacystis were included in the study: 52 with lower urinary tract obstruction, 29 with normal micturition at birth, and 61 with miscellaneous syndromal associations, chromosomal and multiple structural abnormalities (complex megacystis). Only a nuchal translucency > 95th centile, and not a longitudinal bladder diameter ≤15 mm (p = 0.24), significantly increased the risk of complex megacystis (p < 0.01). Cases with a high chance of spontaneous resolution were identified by using the cut-off of 12 mm, as demonstrated in a previous study, and the finding of an associated umbilical cord cyst carried a high-risk of urethral atresia (odds ratio: 15; p = 0.026), an unfavorable condition for antenatal treatment. An algorithm encompassing these three criteria demonstrated good accuracy in selecting fetuses theoretically eligible for fetal treatment (specificity 73%; sensitivity 92%). CONCLUSIONS: Cases theoretically eligible for early fetal therapy are those with normal nuchal translucency, a longitudinal bladder diameter > 12 mm, and without ultrasound evidence of umbilical cord cysts.
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Duodeno/anomalías , Enfermedades Fetales/diagnóstico , Terapias Fetales , Vejiga Urinaria/anomalías , Adulto , Femenino , Enfermedades Fetales/terapia , Humanos , Selección de Paciente , Embarazo , Primer Trimestre del Embarazo , Segundo Trimestre del Embarazo , Estudios Retrospectivos , Ultrasonografía PrenatalRESUMEN
OBJECTIVE: To compare the effects of immediate delivery an expectant management among women whose pregnancies were complicated by preterm prelabor rupture of membranes (PROM) in the late preterm period (from 34 0/7 weeks until 36 6/7 weeks of gestation). DATA SOURCES: PubMed, Scopus, ClinicalTrials.gov, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception until December 2016. METHODS OF STUDY SELECTION: We included all randomized controlled trials with individual participant data reporting on late preterm PROM with randomization to immediate delivery or expectant management. The primary outcome was a composite of adverse neonatal outcomes: probable or definitive neonatal sepsis, necrotizing enterocolitis, respiratory distress syndrome, stillbirth, or neonatal death. TABULATION, INTEGRATION AND RESULTS: Of eight eligible trials (total n=3,203 mothers), three (2,563 mothers, 2,572 neonates) had individual participant data available. The composite adverse neonatal outcome occurred in 9.6% of neonates in the immediate delivery group and 8.3% in the expectant management group (relative risk [RR] 1.20, 95% CI 0.94-1.55). Neonatal sepsis rates were 2.6% and 3.5%, respectively (RR 0.74, 95% CI 0.47-1.15). Neonates in the immediate delivery group were more likely to be diagnosed with respiratory distress syndrome (RR 1.47, 95% CI 1.10-1.97), and to be admitted to the neonatal intensive care unit or special care nursery (RR 1.17, 95% CI 1.11-1.23) and had longer admissions. Mothers randomized to immediate delivery were less likely to have an antepartum hemorrhage (RR 0.57, 95% CI 0.34-0.95) or chorioamnionitis (RR 0.21, 95% CI 0.13-0.35), but more likely to undergo cesarean delivery (RR 1.26, 95% CI 1.08-1.47). CONCLUSION: In women with late preterm PROM, immediate delivery and expectant management resulted in comparable rates of the composite of adverse neonatal outcomes. Effects on individual secondary maternal and neonatal outcomes were mixed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, 42016032972.
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Parto Obstétrico , Rotura Prematura de Membranas Fetales/terapia , Enfermedades del Recién Nacido/epidemiología , Femenino , Humanos , Recién Nacido , EmbarazoRESUMEN
OBJECTIVE: To determine if the verification of short cervical length with a repeated measurement improved the identification of patients with short cervical length at increased risk of preterm delivery. METHODS: The present secondary analysis analyzed prospective cohort study data from patients with singleton pregnancies without a history of preterm delivery who presented for obstetric care in the Netherlands and delivered between November 18, 2009, and January 1, 2013. Cervical length was measured during standard anomaly scan and a second measurement was performed if the cervical length was 30 mm of shorter. Logistic regression and Cox proportional hazards modeling were used to evaluate associations between cervical length measurements and spontaneous preterm delivery before 37 weeks of pregnancy. RESULTS: Cervical length measurements from 12 358 patients were included; 221 (1.8%) had an initial cervical length measurement of 30 mm or shorter. A second cervical length measurement was performed for 167 (75.6%) patients; no differences were identified in the odds of spontaneous preterm delivery when evaluated using the first, second, or a mean of both measurements, regardless of whether cervical length was analyzed as a continuous or dichotomous variable. CONCLUSION: Among patients with singleton pregnancies, verification of short cervical length did not improve the identification of short cervical length.
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Medición de Longitud Cervical/estadística & datos numéricos , Cuello del Útero/diagnóstico por imagen , Nacimiento Prematuro/etiología , Adulto , Medición de Longitud Cervical/métodos , Cuello del Útero/anatomía & histología , Femenino , Humanos , Modelos Logísticos , Países Bajos , Tamaño de los Órganos , Embarazo , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVE: To determine outcome of children born with isolated gastroschisis (no extra-gastrointestinal congenital abnormalities). STUDY DESIGN: International cohort study and meta-analysis. PRIMARY OUTCOME: time to full enteral feeding (TFEF); secondary outcomes: Duration of mechanical ventilation, length of stay (LOS), mortality and differences in outcome between simple and complex gastroschisis (complex; born with bowel atresia, volvulus, perforation or necrosis). To compare the cohort study results with literature three databases were searched. Studies were eligible for inclusion if cases were born in developed countries with isolated gastroschisis after 1990, number of cases >20 and TFEF was reported. RESULTS: The cohort study included 204 liveborn cases of isolated gastroschisis. The TFEF, median duration of ventilation and LOS was, 26days (range 6-515), 2days (range 0-90) and 33days (range 11-515), respectively. Overall mortality was 10.8%. TFEF and LOS were significantly longer (P<0.0001) and mortality was fourfold higher in the complex group. Seventeen studies, amongst the current study, were included for further meta-analysis comprising a total of 1652 patients. Mean TFEF was 35.3±4.4days, length of ventilation was 5.5±2.0days, LOS was 46.4±5.2days and mortality risk was 0.06 [0.04-0.07 95%CI]. Outcome of simple and complex gastroschisis was described in five studies. TFEF, ventilation time, LOS were significant longer and mortality rate was 3.64 [1.95-6.83 95%CI] times higher in complex cases. CONCLUSIONS: These results give a good indication of the expected TFEF, ventilation time and LOS and mortality risk in children born with isolated gastroschisis, although ranges remain wide. This study shows the importance of dividing gastroschisis into simple and complex for the prediction of outcome.
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Gastrosquisis/epidemiología , Gastrosquisis/diagnóstico , Gastrosquisis/terapia , Humanos , Lactante , Mortalidad Infantil , Recién Nacido , Tiempo de Internación/estadística & datos numéricos , Nutrición Parenteral/estadística & datos numéricos , Respiración Artificial/estadística & datos numéricosRESUMEN
BACKGROUND: There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. METHOD: Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. RESULTS: The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adherence 46%), 2) non-progressive labour (frequency 12%, CS performed too early in over 75%), 3) continuous support during labour (frequency 88%, adherence 37%) and 4) previous CS (frequency 12%), with adequate counselling in 15%. CONCLUSIONS: We identified four concrete target groups for improvement of obstetrical care, which can be used as a starting point to reduce CS rates worldwide.
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Cesárea/normas , Adhesión a Directriz/normas , Cesárea/estadística & datos numéricos , Técnica Delphi , Femenino , Guías como Asunto , Humanos , Países BajosRESUMEN
Objective The aim of this study was to assess which characteristics and results of vaginal examination are predictive for delivery within 7 days, in women with threatened preterm labor after initial treatment. Study Design A secondary analysis of a randomized controlled trial on maintenance nifedipine includes women who remained undelivered after threatened preterm labor for 48 hours. We developed one model for women with premature prelabor rupture of membranes (PPROM) and one without PPROM. The predictors were identified by backward selection. We assessed calibration and discrimination and used bootstrapping techniques to correct for potential overfitting. Results For women with PPROM (model 1), nulliparity, history of preterm birth, and vaginal bleeding were included in the multivariable analysis. For women without PPROM (model 2), maternal age, vaginal bleeding, cervical length, and fetal fibronectin (fFN) status were in the multivariable analysis. Discriminative capability was moderate to good (c-statistic 0.68; 95% confidence interval [CI] 0.60-0.77 for model 1 and 0.89; 95% CI, 0.84-0.93 for model 2). Conclusion PPROM and vaginal bleeding in the current pregnancy are relevant predictive factors in all women, as are maternal age, cervical length, and fFN in women without PPROM and nulliparity, history of preterm birth in women with PPROM.
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OBJECTIVE: We recently reported that induction of labour does not improve short term neonatal outcome in women with late preterm premature rupture of membranes (PPROM) as compared to expectant management (PPROMEXIL trial). In this study the neurodevelopmental and behavioural outcome of the children from this trial at 2 years of age was studied. STUDY DESIGN: We studied outcome of offspring of women randomised in the PPROMEXIL study. These women had >24h of ruptured membranes and were between 34 and 37 weeks of pregnancy when they were randomised to induction of labour (IoL) or expectant management (EM). Two years after delivery, the parents received the ages and stages questionnaire (ASQ), the child behaviour checklist (CBCL) and a general questionnaire. RESULTS: Follow-up data were obtained from 234 children (121 after IoL, 113 after EM, response rate 59% (44% of the original 532 randomised women)). In the IoL group 16 children (14%) had an abnormal score in ≥1 domains of the ASQ, versus 27 (26%) in the EM group (difference in percentage -11.4 (95% CI -21.9 to -0.98; p=0.033)). For the CBCL, an abnormal score was found in 13% (n=15) in the IoL group and in 15% (n=16) in the EM group (difference in percentage -2.13 (95% CI -11.2 to 6.94; p=0.645)). CONCLUSION: Although a policy of induction of labour in women with late PPROM does not improve short term neonatal outcome, it might be associated with a decrease in neurodevelopmental difficulties at the age of two years as compared to expectant management. Expectant management did not lead to a difference in behavioural problems.
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Conducta Infantil , Desarrollo Infantil , Rotura Prematura de Membranas Fetales , Trabajo de Parto Inducido , Adulto , Preescolar , Femenino , Estudios de Seguimiento , Humanos , EmbarazoRESUMEN
INTRODUCTION: We investigated the predictive capacity of mid-trimester cervical length (CL) measurement for spontaneous and iatrogenic preterm birth. MATERIAL AND METHODS: We performed a prospective observational cohort study in nulliparous women and low-risk multiparous women with a singleton pregnancy between 16(+0) and 21(+6) weeks of gestation. We assessed the prognostic capacity of transvaginally measured mid-trimester CL for spontaneous and iatrogenic preterm birth (<37 weeks) using likelihood ratios (LR) and receiver-operating-characteristic analysis. We calculated numbers needed to screen to prevent one preterm birth assuming different treatment effects. Main outcome measures were preterm birth <32, <34 and <37 weeks. RESULTS: We studied 11,943 women, of whom 666 (5.6%) delivered preterm: 464 (3.9%) spontaneous and 202 (1.7%) iatrogenic. Mean CL was 44.1 mm (SD 7.8 mm). In nulliparous women, the LRs for spontaneous preterm birth varied between 27 (95% CI 7.7-95) for a CL ≤ 20 mm, and 2.0 (95% CI 1.6-2.5) for a CL between 30 and 35 mm. For low-risk multiparous women, these LRs were 37 (95% CI 7.5-182) and 1.5 (95% CI 0.97-2.2), respectively. Using a cut-off for CL ≤ 30 mm, 28 (6.0%) of 464 women with spontaneous preterm birth were identified. The number needed to screen to prevent one case of preterm birth was 618 in nulliparous women and 1417 for low-risk multiparous women (40% treatment effect, cut-off 30 mm). CONCLUSION: In women at low risk of preterm birth, CL predicts spontaneous preterm birth. However, its isolated use as a screening tool has limited value due to low sensitivity.
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Medición de Longitud Cervical , Cuello del Útero/diagnóstico por imagen , Nacimiento Prematuro/diagnóstico , Nacimiento Prematuro/epidemiología , Adulto , Estudios de Cohortes , Femenino , Humanos , Funciones de Verosimilitud , Países Bajos/epidemiología , Tamaño de los Órganos , Paridad , Embarazo , Segundo Trimestre del Embarazo , Pronóstico , Curva ROCRESUMEN
OBJECTIVE: The aim of the study was to assess the impact of gestational age (GA) at rupture and latency on perinatal outcome after midtrimester prelabor rupture of membranes (PROM). STUDY DESIGN: We obtained data on singleton pregnancies from 22 weeks onwards from the Dutch Perinatal Registry from 1999 to 2007, congenital abnormalities were excluded. In women with PROM before 26 weeks, we studied the impact of GA at rupture and latency on perinatal mortality and morbidity. RESULTS: A total of 1,233 pregnancies were included. Higher GA at delivery appeared to increase the probability of survival without morbidity, GA at PROM did not. In pregnancies of minimum 22 weeks GA, there appeared to be no clear relationship between earlier GA at PROM and adverse outcome. CONCLUSION: Longer latency and early GA at PROM seem to have limited impact in patients delivering after 22 weeks.
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Rotura Prematura de Membranas Fetales , Edad Gestacional , Mortalidad Perinatal , Resultado del Embarazo , Adulto , Femenino , Humanos , Recién Nacido , Masculino , Países Bajos , Embarazo , Segundo Trimestre del Embarazo , Sepsis/epidemiología , Factores de TiempoRESUMEN
BACKGROUND: Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. METHODS/DESIGN: Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. INTERVENTION: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, ß-error 0.2 and α-error 0.05). DISCUSSION: This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. TRIAL REGISTRATION: NTR3492 Dutch Trial Register (http://www.trialregister.nl).
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Parto Obstétrico/métodos , Rotura Prematura de Membranas Fetales/prevención & control , Enfermedades del Recién Nacido/prevención & control , Atención Perinatal/métodos , Segundo Trimestre del Embarazo , Adulto , Femenino , Rotura Prematura de Membranas Fetales/epidemiología , Estudios de Seguimiento , Edad Gestacional , Humanos , Mortalidad Infantil/tendencias , Recién Nacido , Enfermedades del Recién Nacido/epidemiología , Países Bajos/epidemiología , Mortalidad Perinatal/tendencias , Embarazo , Resultado del Embarazo , Estudios RetrospectivosRESUMEN
OBJECTIVE: Women with late preterm premature rupture of membranes (PROM) have an increased risk that their child will develop neonatal sepsis. We evaluated whether neonatal sepsis can be predicted from antepartum parameters in these women. STUDY DESIGN: We used multivariable logistic regression to develop a prediction model. Data were obtained from two recent randomized controlled trials on induction of labor versus expectant management in late preterm PROM (PPROMEXIL trials, (ISRCTN29313500 and ISRCTN05689407). Data from randomized as well as non-randomized women, who consented to the use of their medical data, were used. We evaluated 13 potential antepartum predictors for neonatal sepsis. Missing data were imputed. Discriminative ability of the model was expressed as the area under the receiver operating characteristic (ROC) curve and a calibration with both a calibration plot and the Hosmer and Lemeshow goodness-of-fit test. Overall performance of the prediction model was quantified as the scaled Brier score. RESULTS: We studied 970 women. Thirty-three (3.4%) neonates suffered neonatal sepsis. Maternal age (OR 1.09 per year), maternal CRP level (OR 1.01 per mmol/l), maternal temperature (OR 1.80 per °C) and positive GBS culture (OR 2.20) were associated with an increased risk of neonatal sepsis. The model had an area under the ROC-curve of 0.71. The model had both a good calibration and accuracy. CONCLUSIONS: Antepartum parameters aid in the more precise prediction of the risk of neonatal sepsis in women with late preterm PPROM.
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Rotura Prematura de Membranas Fetales , Enfermedades del Recién Nacido/etiología , Sepsis/etiología , Adulto , Temperatura Corporal , Proteína C-Reactiva/análisis , Femenino , Humanos , Recién Nacido , Persona de Mediana Edad , Modelos Biológicos , Embarazo , Pronóstico , Curva ROC , RiesgoRESUMEN
OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. POPULATION: Women with PPROM near term who were not in labor 24 h after PPROM. METHODS: A cost-minimization analysis was done from a health care provider perspective, using a bottom-up approach to estimate resource utilization, valued with unit-costs reflecting actual costs. MAIN OUTCOME MEASURES: Primary health outcome was the incidence of neonatal sepsis. Direct medical costs were estimated from start of randomization to hospital discharge of mother and child. RESULTS: Induction of labor did not significantly reduce the probability of neonatal sepsis [2.6% vs. 4.1%, relative risk 0.64 (95% confidence interval 0.25-1.6)]. Mean costs per woman were 8094 for induction and 7340 for expectant management (difference 754; 95% confidence interval -335 to 1802). This difference predominantly originated in the postpartum period, where the mean costs were 5669 for induction vs. 4801 for expectant management. Delivery costs were higher in women allocated to induction than in women allocated to expectant management (1777 vs. 1153 per woman). Antepartum costs in the expectant management group were higher because of longer antepartum maternal stays in hospital. CONCLUSIONS: In women with pregnancies complicated by PPROM near term, induction of labor does not reduce neonatal sepsis, whereas costs associated with this strategy are probably higher.
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Rotura Prematura de Membranas Fetales/economía , Rotura Prematura de Membranas Fetales/terapia , Trabajo de Parto Inducido/economía , Espera Vigilante/economía , Adulto , Analgésicos/administración & dosificación , Analgésicos/economía , Control de Costos , Ahorro de Costo , Análisis Costo-Beneficio , Cuidados Críticos/economía , Parto Obstétrico/economía , Femenino , Humanos , Incidencia , Recién Nacido , Cuidado Intensivo Neonatal/economía , Trabajo de Parto Inducido/métodos , Tiempo de Internación/economía , Monitoreo Fisiológico/economía , Países Bajos/epidemiología , Embarazo , Tercer Trimestre del Embarazo , Sepsis/epidemiologíaRESUMEN
OBJECTIVE: The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT trial) showed that in women with suspected intrauterine growth restriction (IUGR) at term, there were no substantial outcome differences between induction of labour and expectant monitoring. The objective of the present analysis is to evaluate whether maternal or fetal markers could identify IUGR fetuses who would benefit from early labour induction. STUDY DESIGN: The DIGITAT trial was a multicenter, parallel and open-label randomised controlled trial in women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected IUGR (n=650). Women had been randomly allocated to either labour induction or expectant monitoring. The primary outcome was a composite measure of adverse neonatal outcome, defined as neonatal death before hospital discharge, Apgar score <7, umbilical artery pH <7.05, or admission to neonatal intensive care. Using logistic regression modelling, we investigated associations between outcome and 17 markers, maternal characteristics and fetal sonographic and Doppler velocimetry measurements, all collected at study entry. RESULTS: 17 (5.3%) infants in the induction group had an adverse neonatal outcome compared to 20 (6.1%) in the expectant monitoring group. The only potentially informative marker for inducing labour was maternal pre-pregnancy body mass index (BMI). Otherwise, we observed at best weak associations between a benefit from labour induction and maternal age, ethnicity, smoking, parity, pregnancy-induced hypertension or preeclampsia, Bishop score and gestational age, or fetal sonographic markers (gender, estimated fetal weight, body measurements, oligohydramnios, or umbilical artery pulsatility index and end diastolic flow). CONCLUSION: In late preterm and term pregnancies complicated by suspected intrauterine growth restriction, most of the known prognostic markers seem unlikely to be helpful in identifying women who could benefit from labour induction, except for maternal pre-pregnancy BMI.
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Puntaje de Apgar , Retardo del Crecimiento Fetal/terapia , Mortalidad Infantil , Trabajo de Parto Inducido/métodos , Desequilibrio Ácido-Base/sangre , Adolescente , Adulto , Índice de Masa Corporal , Femenino , Humanos , Recién Nacido , Inicio del Trabajo de Parto , Flujometría por Láser-Doppler , Masculino , Embarazo , Resultado del Tratamiento , Ultrasonografía Prenatal , Arterias Umbilicales , Espera Vigilante , Adulto JovenRESUMEN
Objective Midtrimester preterm prelabor rupture of membranes (PPROM) has a high rate of neonatal mortality and morbidity. The aim of this study was to study outcomes of subsequent pregnancies after a pregnancy with PPROM before 27 weeks' gestation. Study Design Retrospective study of subsequent pregnancies of women who suffered PPROM before 27 weeks' gestation from 1994 to 2009. The main outcome measure was the risk of recurrence of PPROM before 27 weeks' gestation. The authors also studied preterm birth and pregnancy outcome in the subsequent pregnancy. Finally, they assessed associative factors for subsequent premature delivery. Results They identified 307 patients, of whom 118 women had a subsequent pregnancy. Of 99 women with complete outcome data, 9 women (9%) had PPROM before 27 weeks' gestation in a subsequent pregnancy and 35 women (35%) had a preterm delivery. In 58 (59%) of pregnancies no major complications occurred. They found three associative factors for premature delivery in a subsequent pregnancy: negative vaginal culture for Group B streptococcus, increasing maternal age and early gestational age at PPROM in the index pregnancy. Conclusions Women with PPROM before 27 weeks have a 9% recurrence risk of early PPROM and a risk of 35% of having a preterm delivery in a subsequent pregnancy.
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OBJECTIVE: Pregnancies complicated by intrauterine growth restriction (IUGR) are at increased risk for neonatal morbidity and mortality. The Dutch nationwide disproportionate intrauterine growth intervention trial at term (DIGITAT trial) showed that induction of labour and expectant monitoring were comparable with respect to composite adverse neonatal outcome and operative delivery. In this study we compare the costs of both strategies. STUDY DESIGN: A cost analysis was performed alongside the DIGITAT trial, which was a randomized controlled trial in which 650 women with a singleton pregnancy with suspected IUGR beyond 36 weeks of pregnancy were allocated to induction or expectant management. Resource utilization was documented by specific items in the case report forms. Unit costs for clinical resources were calculated from the financial reports of participating hospitals. For primary care costs Dutch standardized prices were used. All costs are presented in Euros converted to the year 2009. RESULTS: Antepartum expectant monitoring generated more costs, mainly due to longer antepartum maternal stays in hospital. During delivery and the postpartum stage, induction generated more direct medical costs, due to longer stay in the labour room and longer duration of neonatal high care/medium care admissions. From a health care perspective, both strategies generated comparable costs: on average 7106 per patient for the induction group (N=321) and 6995 for the expectant management group (N=329) with a cost difference of 111 (95%CI: -1296 to 1641). CONCLUSION: Induction of labour and expectant monitoring in IUGR at term have comparable outcomes immediately after birth in terms of obstetrical outcomes, maternal quality of life and costs. Costs are lower, however, in the expectant monitoring group before 38 weeks of gestation and costs are lower in the induction of labour group after 38 weeks of gestation. So if induction of labour is considered to pre-empt possible stillbirth in suspected IUGR, it is reasonable to delay until 38 weeks, with watchful monitoring.
Asunto(s)
Retardo del Crecimiento Fetal/economía , Trabajo de Parto Inducido/economía , Ensayos Clínicos Controlados Aleatorios como Asunto/economía , Espera Vigilante/economía , Femenino , Humanos , EmbarazoRESUMEN
BACKGROUND: Preterm prelabour rupture of membranes (PPROM) before 26 weeks can delay lung development and can cause pulmonary hypoplasia, as a result of oligohydramnios. Restoring the amniotic fluid volume by transabdominal amnioinfusion might prevent abnormal lung development and might have a protective effect for neurological complications, fetal deformities and neonatal sepsis. OBJECTIVES: To assess the effectiveness of transabdominal amnioinfusion in improving perinatal outcome in women with oligohydramnios secondary to rupture of fetal membranes before 26 weeks. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). SELECTION CRITERIA: All randomised controlled trials comparing transabdominal amnioinfusion with no transabdominal amnioinfusion. Cluster- or quasi-randomised trials were not eligible for inclusion. In cases where only an abstract was available, we attempted to find the full articles. DATA COLLECTION AND ANALYSIS: Two review authors assessed trials for inclusion. No eligible trials were identified. MAIN RESULTS: There are no included studies. AUTHORS' CONCLUSIONS: There is currently no evidence to evaluate the use of transabdominal amnioinfusion in women with oligohydramnios secondary to rupture of fetal membranes before 26 weeks for improving perinatal outcome. Further research examining the effects of this intervention is needed. Two randomised controlled trials are ongoing but final data have not yet been published.
Asunto(s)
Amnios , Rotura Prematura de Membranas Fetales , Infusiones Parenterales/métodos , Trabajo de Parto Prematuro , Oligohidramnios/terapia , Anomalías Múltiples/prevención & control , Femenino , Fluidoterapia , Edad Gestacional , Humanos , Pulmón/anomalías , Enfermedades Pulmonares/prevención & control , Oligohidramnios/etiología , EmbarazoRESUMEN
OBJECTIVE: Preterm prelabor rupture of membranes (PPROM) before 27 weeks' gestation is associated with severe perinatal complications, but quantitative estimates are lacking. The aim of this study was to report and predict outcomes of pregnancies complicated by early PPROM and to study antepartum risk factors that might predict perinatal death in future patients. STUDY DESIGN: We performed a retrospective cohort study of women with PPROM between 13(+0) weeks and 27(+0) weeks' gestation between 1994 and 2009 in three perinatal centers. MAIN OUTCOME MEASURES: Perinatal mortality, composite neonatal morbidity and premature delivery. A model to predict these outcomes was developed from antepartum variables. RESULTS: We identified 314 women with PPROM before 27 weeks, including 28 multiple pregnancies. Six pregnancies (2%) were terminated before 24 weeks' gestation, and three were lost to follow up, leaving 305 pregnancies for analysis. Overall, there were 166 perinatal deaths (49%). The perinatal mortality rate decreased with increasing gestational age at PPROM (from 70% in the group PPROM 13-20 weeks to 27% in the group PPROM 24-27 weeks). Of the 170 surviving neonates, 70 suffered from serious morbidity (41%). Early gestational age at PPROM, long interval between PPROM and birth and positive vaginal culture (any bacteria) were associated with perinatal mortality. CONCLUSION: Perinatal mortality in PPROM before 27 weeks occurred in half of the cases and among those who survive approximately 40% suffered serious morbidity. Antenatal parameters can be helpful to predict perinatal mortality.