Corine J. M. Verhoeven

Outcomes after Internal versus External Tocodynamometry for Monitoring Labor

BACKGROUNDnIt has been hypothesized that internal tocodynamometry, as compared with external monitoring, may provide a more accurate assessment of contractions and thus improve the ability to adjust the dose of oxytocin effectively, resulting in fewer operative deliveries and less fetal distress. However, few data are available to test this hypothesis.nnnMETHODSnWe performed a randomized, controlled trial in six hospitals in The Netherlands to compare internal tocodynamometry with external monitoring of uterine activity in women for whom induced or augmented labor was required. The primary outcome was the rate of operative deliveries, including both cesarean sections and instrumented vaginal deliveries. Secondary outcomes included the use of antibiotics during labor, time from randomization to delivery, and adverse neonatal outcomes (defined as any of the following: an Apgar score at 5 minutes of less than 7, umbilical-artery pH of less than 7.05, and neonatal hospital stay of longer than 48 hours).nnnRESULTSnWe randomly assigned 1456 women to either internal tocodynamometry (734) or external monitoring (722). The operative-delivery rate was 31.3% in the internal-tocodynamometry group and 29.6% in the external-monitoring group (relative risk with internal monitoring, 1.1; 95% confidence interval [CI], 0.91 to 1.2). Secondary outcomes did not differ significantly between the two groups. The rate of adverse neonatal outcomes was 14.3% with internal monitoring and 15.0% with external monitoring (relative risk, 0.95; 95% CI, 0.74 to 1.2). No serious adverse events associated with use of the intrauterine pressure catheter were reported.nnnCONCLUSIONSnInternal tocodynamometry during induced or augmented labor, as compared with external monitoring, did not significantly reduce the rate of operative deliveries or of adverse neonatal outcomes. (Current Controlled Trials number, ISRCTN13667534; Netherlands Trial number, NTR285.)

Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial

BACKGROUNDnExisting approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy.nnnMETHODSnIn this multicentre prospective cohort study with an embedded randomised controlled trial, we screened women (aged ≥18 years) at eight hospitals and five ultrasound centres in the Netherlands with a singleton pregnancy between 16 and 22 weeks gestation for asymptomatic bacteriuria. Screening was done with a single dipslide and two culture media. Dipslides were judged positive when the colony concentration was at least 1×10(5) colony-forming units (CFU) per mL of a single microorganism or when two different colony types were present but one had a concentration of at least 1×10(5) CFU per mL. Asymptomatic bacteriuria-positive women were eligible to participate in the randomised controlled trial comparing nitrofurantoin with placebo treatment. In this trial, participants were randomly assigned 1:1 to receive either nitrofurantoin 100 mg or identical placebo tablets, and were instructed to self-administer these tablets twice daily for 5 consecutive days. Randomisation was done by a web-based application with a computer-generated list with random block sizes of two, four, or six participants rendered by an independent data manager. 1 week after the end of treatment, they provided us with a follow-up dipslide. Women, treating physicians, and researchers all remained unaware of the bacteriuria status and treatment allocation. Women who refused to participate in the randomised controlled trial did not receive any antibiotics, but their outcomes were collected for analysis in the cohort study. We compared untreated and placebo-treated asymptomatic bacteriuria-positive women with asymptomatic bacteriuria-negative women and nitrofurantoin-treated asymptomatic bacteriuria-positive women. The primary endpoint was a composite of pyelonephritis with or without preterm birth at less than 34 weeks, analysed by intention to treat at 6 weeks post-partum. This trial is registered with the Dutch Trial Registry, number NTR3068.nnnFINDINGSnBetween Oct 11, 2011, and June 10, 2013, we enrolled 5621 women into our screening cohort, of whom 5132 were eligible for screening. After exclusions for contaminated dipslides and patients lost to follow-up, in our final cohort of 4283 women, 248 were asymptomatic bacteriuria positive, of whom 40 were randomly assigned to nitrofurantoin and 45 to placebo for the randomised controlled trial, whereas the other 163 asymptomatic bacteriuria-positive women were followed without treatment. The proportion of women with pyelonephritis, preterm birth, or both did not differ between untreated or placebo-treated asymptomatic bacteriuria-positive women and asymptomatic bacteriuria-negative women (6 [2·9%] of 208 vs 77 [1·9%] of 4035; adjusted odds ratio [OR] 1·5, 95% CI 0·6-3·5) nor between asymptomatic bacteriuria-positive women treated with nitrofurantoin versus those who were untreated or received placebo (1 [2·5%] of 40 vs 6 [2·9%] of 208; risk difference -0·4, 95% CI -3·6 to 9·4). Untreated or placebo-treated asymptomatic bacteriuria-positive women developed pyelonephritis in five [2·4%] of 208 cases, compared with 24 [0·6%] of 4035 asymptomatic bacteriuria-negative women (adjusted OR 3·9, 95% CI 1·4-11·4).nnnINTERPRETATIONnIn women with an uncomplicated singleton pregnancy, asymptomatic bacteriuria is not associated with preterm birth. Asymptomatic bacteriuria showed a significant association with pyelonephritis, but the absolute risk of pyelonephritis in untreated asymptomatic bacteriuria is low. These findings question a routine screen-treat-policy for asymptomatic bacteriuria in pregnancy.nnnFUNDINGnZonMw (the Netherlands Organisation for Health Research and Development).

The Bishop Score as a Predictor of Labor Induction Success: A Systematic Review

OBJECTIVEnTo assess the ability of the Bishop score to predict the mode of delivery in women scheduled for induction of labor at term.nnnSTUDY DESIGNnWe performed a systematic literature search of electronic databases from inception to July 2009. Studies reporting on both the Bishop score and the outcome of labor in women scheduled for induction of labor at term were eligible. We used a bivariate model to estimate a summary receiver operating characteristic (sROC) curve for the outcome cesarean delivery.nnnRESULTSnWe included 40 primary articles reporting on 13,757 women. Study quality was mediocre. The sROC curve of the Bishop score in the prediction of cesarean delivery indicated a poor predictive capacity. For the prediction of cesarean delivery, the sensitivity-specificity combinations were 47%-75%, 61%-53% and 78%-44% for the Bishop scores of 4, 5, and 6, respectively. For a Bishop score below 9, the sensitivity-specificity combination was 95%-30%.nnnCONCLUSIONnThe Bishop score is a poor predictor for the outcome of induced labor at term and should not be used to decide whether to induce labor or not.

Transvaginal sonographic assessment of cervical length and wedging for predicting outcome of labor induction at term: a systematic review and meta‐analysis

To perform a systematic review and meta‐analysis to assess the predictive capacity of transvaginal sonographic assessment of the cervix for the outcome of induction of labor.

Ultrasonographic fetal head position to predict mode of delivery: a systematic review and bivariate meta‐analysis

We performed a systematic review to determine whether sonographic assessment of occipital position of the fetal head can contribute to the prediction of the mode of delivery.

Development of the Pregnancy and Childbirth Questionnaire (PCQ): evaluating quality of care as perceived by women who recently gave birth

OBJECTIVEnTo develop an instrument to the assess quality of care during pregnancy and delivery as perceived by women who recently gave birth.nnnSTUDY DESIGNnProspective design from focus group interviews to validation of the questionnaire. The focus groups consisted of seven care providers, ten pregnant women and six women who recently gave birth. With the results of the focus group interviews, a draft questionnaire of 52 items was composed and its psychometric properties were tested in a first cohort of 300 women who recently gave birth (sample I) by means of exploratory factor analysis (EFA) and reliability analysis. The final version was further explored by confirmatory factor analyses (CFA) in another sample of 289 women (sample II) with similar characteristics as sample I.nnnRESULTSnEFA in sample I suggested an 18-item scale with two components concerning the quality of care during pregnancy: personal treatment (11 items, Cronbachs alpha (α)=0.87) and educational information (7 items, α=0.90); the delivery scale showed a single domain (7 items, α=0.88). CFA in sample II confirmed both factor structures with an adequate model fit. Overall, satisfaction with care was highest among women who only received midwife-led care, while women who were referred to an obstetrician during pregnancy reported less satisfaction.nnnCONCLUSIONSnThe 25-item PCQ, primarily based on the experiences and perceptions of pregnant women and women who recently gave birth, showed adequate psychometric properties evaluating the quality of care during pregnancy and delivery. This user-friendly instrument might be a valuable instrument for future research to further evaluate the quality of care to pregnant women.

Costs and effects of screening and treating low risk women with a singleton pregnancy for asymptomatic bacteriuria, the ASB study

BackgroundThe prevalence of asymptomatic bacteriuria (ASB) in pregnancy is 2-10% and is associated with both maternal and neonatal adverse outcomes as pyelonephritis and preterm delivery. Antibiotic treatment is reported to decrease these adverse outcomes although the existing evidence is of poor quality.Methods/DesignWe plan a combined screen and treat study in women with a singleton pregnancy. We will screen women between 16 and 22u2009weeks of gestation for ASB using the urine dipslide technique. The dipslide is considered positive when colony concentration ≥105 colony forming units (CFU)/mL of a single microorganism or two different colonies but one ≥105u2009CFU/mL is found, or when Group B Streptococcus bacteriuria is found in any colony concentration. Women with a positive dipslide will be randomly allocated to receive nitrofurantoin or placebo 100u2009mg twice a day for 5 consecutive days (double blind). Primary outcomes of this trial are maternal pyelonephritis and/or preterm delivery before 34u2009weeks. Secondary outcomes are neonatal and maternal morbidity, neonatal weight, time to delivery, preterm delivery rate before 32 and 37u2009weeks, days of admission in neonatal intensive care unit, maternal admission days and costs.DiscussionThis trial will provide evidence for the benefit and cost-effectiveness of dipslide screening for ASB among low risk women at 16–22u2009weeks of pregnancy and subsequent nitrofurantoin treatment.Trial registrationDutch trial registry: NTR-3068

Comparison of Induction of Labour and Expectant Management in Postterm Pregnancy: A Matched Cohort Study

Randomized clinical trials have shown that induction of labour does not result in higher caesarean delivery rates in women who are postterm. Despite this evidence, the policy of inducing women who are postterm is not generally applied in the Netherlands. This provides us with the opportunity to assess whether the findings from randomized studies can also be observed in nonrandomized studies and to validate these findings in the Dutch obstetric population. We performed a retrospective matched cohort study (1:1 ratios for both age and parity) in women with uncomplicated pregnancies of 42 weeks duration and compared induction of labour with a policy of serial antenatal monitoring. Analyses were made by the intention to treat principle. We studied 674 women. Among the 337 women in the expectant management group, 42 (12.5%) underwent caesarean delivery, compared to 46 (13.6%) of the 337 women in the induction group (relative risk [RR], 0.9; 95% confidence interval [CI], 0.6-1.4). However, the incidence of shoulder dystocia (RR, 4.3; 95% CI, 1.3-15) and meconium-stained amniotic fluid (RR, 1.8; 95% CI, 1.4-2.3) were higher in the expectant management group. Induction of labour does not result in an increased risk of caesarean delivery in women who are postterm. Because epidemiologic studies suggest an increased risk of perinatal death and birth injury beyond 42 weeks gestation, induction of labour should be offered to all women who are postterm.

Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial

OBJECTIVEnThe objective of this study was to evaluate the effectiveness of vaginal progesterone in reducing adverse neonatal outcome due to preterm birth (PTB) in low-risk pregnant women with a short cervical length (CL).nnnSTUDY DESIGNnWomen with a singleton pregnancy without a history of PTB underwent CL measurement at 18 to 22 weeks. Women with a CLu2009≤u200930u2009mm received vaginal progesterone or placebo. Primary outcome was adverse neonatal outcome, defined as a composite of respiratory distress syndrome, bronchopulmonary dysplasia, intracerebral hemorrhageu2009>u2009grade II, necrotizing enterocolitisu2009>u2009stage 1, proven sepsis, or death before discharge. Secondary outcomes included time to delivery, PTB before 32, 34, and 37 weeks of gestation. Analysis was by intention to treat.nnnRESULTSnBetween 2009 and 2013, 20,234 women were screened. A CL of 30u2009mm or less was seen in 375 women (1.8%). In 151 women, a CLu2009≤u200930u2009mm was confirmed with a second measurement and 80 of these women agreed to participate in the trial. We randomly allocated 41 women to progesterone and 39 to placebo. Adverse neonatal outcomes occurred in two (5.0%) women in the progesterone and in four (11%) women in the control group (relative risk [RR], 0.47; 95% confidence interval [CI], 0.09-2.4). The use of progesterone resulted in a nonsignificant reduction of PTBu2009<u200932 weeks (2.0 vs. 8.0%; RR, 0.33; 95% CI, 0.04-3.0) andu2009<u200934 weeks (7.0 vs. 10%; RR, 0.73; 95% CI, 0.18-3.1) but not on PTBu2009<u200937 weeks (15 vs. 13%; RR, 1.2; 95% CI, 0.39-3.5).nnnCONCLUSIONnIn women with a short cervix, who are otherwise low risk, we could not show a significant benefit of progesterone in reducing adverse neonatal outcome and PTB.

The capacity of mid-pregnancy cervical length to predict preterm birth in low-risk women: a national cohort study

We investigated the predictive capacity of mid‐trimester cervical length (CL) measurement for spontaneous and iatrogenic preterm birth.