David van der Ham

Induction of Labor versus Expectant Management in Women with Preterm Prelabor Rupture of Membranes between 34 and 37 Weeks: A Randomized Controlled Trial

In a randomized controlled trial David van der Ham and colleagues investigate induction of labor versus expectant management for women with preterm prelabor rupture of membranes.

Accuracy of C-reactive protein determination in predicting chorioamnionitis and neonatal infection in pregnant women with premature rupture of membranes: A systematic review

Preterm premature rupture of the fetal membranes (PPROM) is associated with intra-uterine infection. Early detection of intra-uterine infection may help prevent neonatal sepsis. C-reactive protein (CRP) is an acute phase protein often elevated when inflammation is present. The aim of this review was to assess whether CRP accurately predicts chorioamnionitis and/or neonatal sepsis in women with PPROM. We searched Medline and Embase databases for articles reporting on CRP and chorioamnionitis and/or neonatal sepsis. Two reviewers extracted clinical and methodological study characteristics and test accuracy data. Accurate data were used to form 2 x 2 data tables comparing CRP and the occurrence of infection. For the selected studies, sensitivity and specificity of CRP in the prediction of histological chorioamnionitis, clinical chorioamnionitis and neonatal sepsis were calculated separately. A bivariate meta-regression model was used to calculate pooled estimates of sensitivity and specificity. The search revealed 200 articles, of which only five met the inclusion criteria. These five articles reported on 381 patients, of which four articles (227 patients) reported on CRP as a predictor for histological chorioamnionitis and four studies (330 patients) reported on CRP as a predictor for clinical chorioamnionitis. None of the selected articles fulfilled our criteria for the use of CRP as a predictor of neonatal sepsis. CRP was moderately predictive of histological chorioamnionitis. Unfortunately, the studies of clinical chorioamnionitis were too heterogeneous to pool data. Current literature does not support the use of CRP in women with PPROM.

Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial)

BackgroundPreterm prelabour rupture of the membranes (PPROM) is an important clinical problem and a dilemma for the gynaecologist. On the one hand, awaiting spontaneous labour increases the probability of infectious disease for both mother and child, whereas on the other hand induction of labour leads to preterm birth with an increase in neonatal morbidity (e.g., respiratory distress syndrome (RDS)) and a possible rise in the number of instrumental deliveries.Methods/DesignWe aim to determine the effectiveness and cost-effectiveness of immediate delivery after PPROM in near term gestation compared to expectant management. Pregnant women with preterm prelabour rupture of the membranes at a gestational age from 34+0 weeks until 37+0 weeks will be included in a multicentre prospective randomised controlled trial. We will compare early delivery with expectant monitoring.The primary outcome of this study is neonatal sepsis. Secondary outcome measures are maternal morbidity (chorioamnionitis, puerperal sepsis) and neonatal disease, instrumental delivery rate, maternal quality of life, maternal preferences and costs. We anticipate that a reduction of neonatal infection from 7.5% to 2.5% after induction will outweigh an increase in RDS and additional costs due to admission of the child due to prematurity. Under these assumptions, we aim to randomly allocate 520 women to two groups of 260 women each. Analysis will be by intention to treat. Additionally a cost-effectiveness analysis will be performed to evaluate if the cost related to early delivery will outweigh those of expectant management. Long term outcomes will be evaluated using modelling.DiscussionThis trial will provide evidence as to whether induction of labour after preterm prelabour rupture of membranes is an effective and cost-effective strategy to reduce the risk of neonatal sepsis.Controlled clinical trial registerISRCTN29313500

Neonatal outcome of pregnancies complicated by hypertensive disorders between 34 and 37 weeks of gestation : a 7 year retrospective analysis of a national registry

OBJECTIVE The objective of the study was to determine the neonatal morbidity in late preterm infants born from mothers with a hypertensive disorder. STUDY DESIGN Data were obtained from the national Perinatal Registry in The Netherlands on women who delivered between 34(+0) and 36(+6) weeks with gestational hypertension (n = 4316), preeclampsia (n = 1864), and normotensive controls (n = 20,749). RESULTS Children from mothers with preeclampsia had an increased risk for admission to the neonatal intensive care unit compared with children from normotensive mothers (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.8-2.2). A cesarean delivery and decreasing gestational age were independent risk factors for neonatal respiratory morbidity. Gestational hypertension or preeclampsia reduced the risk of respiratory distress syndrome compared with the control group (OR, 0.81; 95% CI, 0.64-1.0 and OR, 0.69; 95% CI, 0.49-0.96, respectively). CONCLUSION Neonatal morbidity in the late preterm period is considerable. Hypertensive disorders appear to protect for neonatal respiratory morbidity, but higher rates of cesarean section diminish this protective effect.

Methods for the diagnosis of rupture of the fetal membranes in equivocal cases: a systematic review

Prelabor rupture of membranes (PROM) is a common obstetrical problem, but its diagnosis is frequently problematic. Lacking a gold standard, the diagnosis is equivocal in some 10% of cases. We performed a systematic review to assess the accuracy of several tests for the diagnosis of PROM in these equivocal cases. We performed an electronic search in PubMed, Embase, DARE and the Cochrane Library and reference lists for potentially missed articles. No language restrictions were used. Only accuracy studies for diagnostic methods for PROM in women with equivocal PROM were selected. The studies were scored according to STARD and QUADAS guidelines. Based on the full description of reference and index tests, an expert panel finally decided whether the selected articles were of sufficient quality to be included. We identified 3864 studies of which 146 full manuscripts were obtained. We excluded 133 due to multiple reasons. The remaining 13 studies were scored by an expert panel. Only three articles with a total of 155 patients fulfilled all criteria. These articles tested three different methods, pH measurement (64 patients), insulin-like growth factor binding protein-1 (ILGBP-1, 83 patients) and alpha fetoprotein (AFP, 8 patients). Sensitivity varied from 88% (pH) to 100% (AFP), specificity varied from 56% (ILGPP-1) to 100% (AFP). Based on the limited evidence on the accuracy of tests to diagnose ruptured membranes, we conclude that the use of a particular test cannot be recommended.

The accuracy of clinical parameters in the prediction of perinatal pulmonary hypoplasia secondary to midtrimester prelabour rupture of fetal membranes: A meta-analysis

Prediction of pulmonary hypoplasia after midtrimester preterm prelabour rupture of membranes (PPROM) is important for optimal management. We performed a systematic review to assess the capacity of clinical parameters to predict pulmonary hypoplasia. A systematic literature search in EMBASE and MEDLINE was performed to identify articles published on pulmonary hypoplasia in relation to midtrimester PPROM. Articles were selected when they reported on one of the following clinical parameters - gestational age at PPROM, latency period and degree of oligohydramnios - and when they allowed the construction of a two-by-two table comparing at least one of three clinical parameters to the occurrence of pulmonary hypoplasia. The selected studies were scored on methodological quality, and sensitivity and specificity of the tests in the prediction of pulmonary hypoplasia and lethal pulmonary hypoplasia were calculated. Overall performance was assessed by summary receiver operating characteristic (sROC) curves that were constructed with bivariate meta-analysis. We detected 28 studies that reported on the prediction of pulmonary hypoplasia. Prediction of lethal pulmonary hypoplasia could be analysed separately in 21 of these studies. The quality of the included studies was poor. The estimated sROC-curves showed that gestational age at PPROM performed significantly better than the two other parameters in the prediction of pulmonary hypoplasia. The accuracy in the prediction of lethal pulmonary hypoplasia was similar. In women with midtrimester PPROM, pulmonary hypoplasia can be predicted from the gestational age at PPROM. This information should be used in the management of women with early PPROM.

Meta-analysis shows that infants who have suffered neonatal sepsis face an increased risk of mortality and severe complications.

Infants suffering from neonatal sepsis face an increased risk of early death and long‐term neurodevelopmental delay. This paper analyses and summarises the existing data on short‐term and long‐term outcomes of neonatal sepsis, based on 12 studies published between January 2000 and 1 April 2012 and covering 3669 neonates with sepsis.

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM).

Prelabour rupture of membranes: overview of diagnostic methods.

Purpose of review To evaluate diagnostic accuracy studies for rupture of the fetal membranes (ROM). Recent findings Sample sizes of recent studies are small and studies used different ‘silver standard’ definitions for ROM. Therefore, reported results should be interpreted with caution. Over the review period the focus of diagnostic studies has been on two bedside test strips: insulin-like growth factor-binding protein-1 (IGFBP-1) and placental &agr; microglobulin-1 (PAMG-1). Bedside tests improve the confidence of the clinician about their diagnosis. Compared to nitrazine or ferning test alone, IGFBP-1 and PAMG-1 are more accurate. However, compared to the conventional testing (combination of history, ferning, nitrazine, speculum and ultrasound) no statistical difference in accuracy was found. In-vitro PAMG-1 is shown to be superior to IGFPB-1. Furthermore, soluble intercellular adhesion molecule-1 and Axl receptor tyrosine kinase (Axl) seem to be promising new specific biomarkers for diagnosing ROM. Summary IGFBP-1 and PAMG-1 are the most commonly used bedside tests for diagnosing ROM. Both tests seem to be sensitive and specific, however, evidence is lacking especially in equivocal cases and comparative studies against the real gold standard (amnio-dye) have still not been published. Further effectiveness research is needed before tests can be applied in practice.

Can neonatal sepsis be predicted in late preterm premature rupture of membranes? Development of a prediction model

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.