Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial.

BACKGROUND: At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. METHODS AND FINDINGS: We conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM. CONCLUSIONS: In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN29313500

Can a developed country's maternal mortality review be used as the 'gold standard' for a developing country?

BACKGROUND: Relative to other public health problems, maternal mortality ratio (MMR) differences between developed and developing countries are greater than expected. South Africa (SA) produced its first national report on maternal deaths in 1998. UK's last report covered the period 1994-1996. OBJECTIVE AND METHOD: Compare the two reports to document reasons for the MMR differences using the Safe Motherhood analytical model of maternal mortality as a template. RESULTS: The MMR for SA was estimated to be 12.3 times greater than the UK's. Under-reporting was bigger in SA. Substandard medical care was common, but other quality of care issues were not assessed. Disease pattern differences included AIDS, non-pregnancy-related infections and postpartum haemorrhage in SA compared to thromboembolism and medical disorders in the UK. Autopsies were problematic. Demographic differences centred around ethnic origins. Biological differences may involve the immune system. Socio-economic or behavioural factors were not documented. CONCLUSIONS: Awareness of the magnitude of the problem requires better data collection systems. Sepsis and HIV/AIDS are a major problem in SA. Beyond the mutually common problem of substandard medical care, other quality of care issues were inadequately assessed.

Severe acute maternal morbidity and mortality in the Pretoria Academic Complex: changing patterns over 4 years.

OBJECTIVE: To compare the severe acute maternal morbidity (SAMM) and maternal mortality in the Pretoria Academic Complex for the year 2000 and the years 1997-1999. STUDY DESIGN: SAMM and maternal mortality was identified at daily audit meetings. The audit was performed from 1 January 2000 to 31 December 2000 and compared with the data obtained from the original 2-year audit [Br J Obstet Gynecol 105 (1998) 985]. The mortality index (MI) was defined as Maternal Death (MD) divided by SAMM and MD. This index is used to assess the standard of care in specific maternal conditions. Data was assessed using the Chi square test. RESULTS: SAMM and maternal mortality has significantly declined in all patients with a reduction in abortion complications as the main contributor (268/100,000 births versus 94/100,000 births P<0.006). There is a non-significant trend to increased morbidity and mortality in hypertension, hemorrhage and infections. CONCLUSIONS: The standard of care was constant. An audit of SAMM and maternal mortality allows for early detection of trends and early changes in health strategies.

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.