Involving women in personalised decision-making on mode of delivery after caesarean section: the development and pilot testing of a patient decision aid.

OBJECTIVE: To develop a patient decision aid (PtDA) for mode of delivery after caesarean section that integrates personalised prediction of vaginal birth after caesarean (VBAC) with the elicitation of patient preferences and evidence-based information. DESIGN: A PtDA was developed and pilot tested using the International Patients Decision Aid Standards (IPDAS) criteria. SETTING: Obstetric health care in the Netherlands. POPULATION: A multidisciplinary steering group, an expert panel, and 25 future users of the PtDA, i.e. women with a previous caesarean section. METHODS: The development consisted of a construction phase (definition of scope and purpose, and selection of content, framework, and format) and a pilot testing phase by interview. The process was supervised by a multidisciplinary steering group. MAIN OUTCOME MEASURES: Usability, clarity, and relevance. RESULTS: The construction phase resulted in a booklet including unbiased balanced information on mode of birth after caesarean section, a preference elicitation exercise, and tailored risk information, including a prediction model for successful VBAC. During pilot testing, visualisation of risks and clarity formed the main basis for revisions. Pilot testing showed the availability of tailored structured information to be the main factor involving women in decision-making. The PtDA meets 39 out of 50 IPDAS criteria (78%): 23 out of 23 criteria for content (100%) and 16 out of 20 criteria for the development process (80%). Criteria for effectiveness (n = 7) were not evaluated. CONCLUSIONS: An evidence-based PtDA was developed, with the probability of successful VBAC and the availability of structured information as key items. It is likely that the PtDA enhances the quality of decision-making on mode of birth after caesarean section.

No effect of the FitFor2 exercise programme on blood glucose, insulin sensitivity, and birthweight in pregnant women who were overweight and at risk for gestational diabetes: results of a randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of an exercise programme for pregnant women who were overweight or obese and at risk for gestational diabetes mellitus (GDM). DESIGN: Randomised controlled trial. SETTING: Hospitals and midwifery practices in the Netherlands. POPULATION: Pregnant women who were overweight or obese and at risk for GDM between 2007 and 2011. METHODS: Normal care was compared with an exercise training programme during pregnancy. The training consisted of aerobic and strength exercises, and was aimed at improving maternal fasting blood glucose, insulin sensitivity, and birthweight. Linear regression analyses were performed to determine the effects. MAIN OUTCOME MEASURES: Maternal outcome measures were fasting blood glucose (mmol/l), fasting insulin (pmol/l) and HbA1c (%), body weight (kg), body mass index (kg/m(2) ), and daily physical activity (minute/week). Offspring outcome measures were birthweight and fetal growth. RESULTS: A total of 121 women were randomly allocated to either a control (n = 59) or an intervention (n = 62) group. Intention-to-treat analysis showed that the exercise programme did not reduce maternal fasting blood glucose levels nor insulin sensitivity. Also, no effect was found on birthweight. CONCLUSIONS: The exercise intervention performed over the second and third trimester of pregnancy had no effects on fasting blood glucose, insulin sensitivity, and birthweight, most probably because of low compliance. The high prevalence of women at risk for GDM calls for further research on possible interventions that can prevent GDM, and other types of interventions to engage this target group in physical activity and exercise.

A clinical prediction model to assess the risk of operative delivery.

OBJECTIVE: To predict instrumental vaginal delivery or caesarean section for suspected fetal distress or failure to progress. DESIGN: Secondary analysis of a randomised trial. SETTING: Three academic and six non-academic teaching hospitals in the Netherlands. POPULATION: 5667 labouring women with a singleton term pregnancy in cephalic presentation. METHODS: We developed multinomial prediction models to assess the risk of operative delivery using both antepartum (model 1) and antepartum plus intrapartum characteristics (model 2). The models were validated by bootstrapping techniques and adjusted for overfitting. Predictive performance was assessed by calibration and discrimination (area under the receiver operating characteristic), and easy-to-use nomograms were developed. MAIN OUTCOME MEASURES: Incidence of instrumental vaginal delivery or caesarean section for fetal distress or failure to progress with respect to a spontaneous vaginal delivery (reference). RESULTS: 375 (6.6%) and 212 (3.6%) women had an instrumental vaginal delivery or caesarean section due to fetal distress, and 433 (7.6%) and 571 (10.1%) due to failure to progress, respectively. Predictors were age, parity, previous caesarean section, diabetes, gestational age, gender, estimated birthweight (model 1) and induction of labour, oxytocin augmentation, intrapartum fever, prolonged rupture of membranes, meconium stained amniotic fluid, epidural anaesthesia, and use of ST-analysis (model 2). Both models showed excellent calibration and the receiver operating characteristics areas were 0.70-0.78 and 0.73-0.81, respectively. CONCLUSION: In Dutch women with a singleton term pregnancy in cephalic presentation, antepartum and intrapartum characteristics can assist in the prediction of the need for an instrumental vaginal delivery or caesarean section for fetal distress or failure to progress.

[Prevention of neonatal infection with group B streptococci: what the best strategy is remains unclear]. / Preventie van neonatale infectie met groep B-streptokokken: onduidelijk welke strategie de beste is.

Early-onset group B streptococcal disease (GBS disease) is an important cause of morbidity and mortality in newborn infants. There is no international agreement on the best strategy for selecting pregnant women for antibiotic prophylaxis during delivery in order to reduce the incidence of this disease. A cost-effectiveness study of 4 strategies using a theoretical model showed that the risk strategy (antibiotics for women at risk) and combination strategy (antibiotics for GBS-positive women at risk) seemed more cost-effective than the current Dutch strategy (antibiotics for women at risk ifGBS positive) and the screening strategy (antibiotics for GBS-positive women). Balancing the possible effects, costs, unwanted side effects, and limitations of the implementation of either strategy in the Netherlands, the combination strategy may be a reasonable option. The possibly favourable introduction of PCR screening techniques and vaginal chlorhexidine flushing in Dutch obstetric practice deserves further scientific attention.

Intrapartum and neonatal mortality in primary midwife-led and secondary obstetrician-led care in the Amsterdam region of the Netherlands: A retrospective cohort study.

OBJECTIVE: To compare intrapartum- and neonatal mortality and intervention rates in term women starting labour in primary midwife-led versus secondary obstetrician-led care. DESIGN: Retrospective cohort study. SETTING: Amsterdam region of the Netherlands. PARTICIPANTS: Women with singleton pregnancies who gave birth beyond 37+0 weeks gestation in the years 2005 up to 2008 and lived in the catchment area of the neonatal intensive care units of both academic hospitals in Amsterdam. Women with a primary caesarean section or a pregnancy complicated by antepartum death or major congenital anomalies were excluded. For women in the midwife-led care group, a home or hospital birth could be planned. MEASUREMENTS: Analysis of linked data from the national perinatal register, and hospital- and midwifery record data. We assessed (unadjusted) relative risks with confidence intervals. Main outcome measures were incidences of intrapartum and neonatal (<28 days) mortality. Secondary outcomes included incidences of caesarean section and vaginal instrumental delivery. FINDINGS: 53,123 women started labour in primary care and 30,166 women in secondary care. Intrapartum and neonatal mortality rates were 37/53,123 (0.70‰) in the primary care group and 24/30,166 (0.80‰) in the secondary care group (relative risk 0.88; 95% CI 0.52-1.46). Women in the primary care group were less likely to deliver by secondary caesarean section (5% versus 16%; RR 0.31; 95% CI 0.30-0.32) or by instrumental delivery (10% versus 13%; RR 0.76; 95% CI 0.73-0.79). KEY CONCLUSIONS: We found a low absolute risk of intrapartum and neonatal mortality, with a comparable risk for women who started labour in primary versus secondary care. The intervention rate was significantly lower in women who started labour in primary care. IMPLICATIONS FOR PRACTICE: These findings suggest that it is possible to identify a group of women at low risk of complications that can start labour in primary care and have low rates of medical interventions whereas perinatal mortality is low.

[Malacoplakia of the female genital tract in a woman with postmenopausal bleeding]. / Malacoplakie van de tractus genitalis bij een vrouw met postmenopauzaal bloedverlies.

A 74-year-old woman had vaginal bleeding for 6 months with no other complaints. A suspected tumour was visible on the cervix and the endometrium was slightly thickened. Histological examination revealed Michaelis-Gutmann bodies. Following antibiotic treatment, the tumour and the bleeding disappeared. Malacoplakia is a chronic inflammation which usually arises in the urinary tract of older women and, rarely, in the female genital tract. The abnormality often appears to be a malignancy, although histologically it is an inflammatory condition. Histological examination is necessary to establish the diagnosis. Treatment usually consists of antibiotics and surgical excision.

Rapid target allopurinol concentrations in the hypoxic fetus after maternal administration during labour.

OBJECTIVE: Perinatal hypoxia-induced free radical formation is an important cause of hypoxic-ischaemic encephalopathy and subsequent neurodevelopmental disabilities. Allopurinol reduces the formation of free radicals, which potentially limits hypoxia-induced brain damage. We investigated placental transfer and safety of allopurinol after maternal allopurinol treatment during labour to evaluate its potential role as a neuroprotective agent in suspected fetal hypoxia. DESIGN: We used data from a randomised, double-blind multicentre trial comparing maternal allopurinol versus placebo in case of imminent fetal hypoxia (NCT00189007). PATIENTS: We studied 58 women in labour at term, with suspected fetal hypoxia prompting immediate delivery, in the intervention arm of the study. SETTING: Delivery rooms of 11 Dutch hospitals. INTERVENTION: 500 mg allopurinol, intravenously to the mother, immediately prior to delivery. MAIN OUTCOME MEASURES: Drug disposition (maternal plasma concentrations, cord blood concentrations) and drug safety (maternal and fetal adverse events). RESULTS: Within 5 min after the end of maternal allopurinol infusion, target plasma concentrations of allopurinol of ≥2 mg/L were present in cord blood. Of all analysed cord blood samples, 95% (52/55) had a target allopurinol plasma concentration at the moment of delivery. No adverse events were observed in the neonates. Two mothers had a red and/or painful arm during infusion. CONCLUSIONS: A dose of 500 mg intravenous allopurinol rapidly crosses the placenta and provides target concentrations in 95% of the fetuses at the moment of delivery, which makes it potentially useful as a neuroprotective agent in perinatology with very little side effects. TRIAL REGISTRATION: The study is registered in the Dutch Trial Register (NTR1383) and the Clinical Trials protocol registration system (NCT00189007).

Comparative analysis of recommendations in local Dutch guidelines on 'Hypertension and pregnancy'.

OBJECTIVE: Hypertensive disorders in pregnancy remain the most prevalent cause of maternal and fetal morbidity and mortality. We hypothesise that incompleteness of local protocols 'Hypertension during pregnancy' might be associated with adverse obstetric outcome. Therefore, we analyzed the contents of the local Dutch protocols. STUDY DESIGN: We analyzed local Dutch protocols on 'Hypertension during pregnancy' using qualitative methods to score the completeness using the national guideline as standard. Indicators were designed using key recommendation from the national Dutch guideline 'Hypertension during pregnancy' (n=83 indicators), 22 of these indicators were classified as crucial indicators. Deficiencies in the local Dutch protocols, differences between the protocols and differences between the protocols of academically affiliated hospitals, teaching non-academic hospitals and non-teaching hospitals were analyzed using ANOVA test. RESULTS: The median total score of the local protocols is 32.5 (max 83, range from 2 to 55). Thirteen indicators were described in less than 10% of the local protocols. We found more indicators lacking in the non-teaching hospitals protocols compared to academically affiliated hospitals and teaching non-academically hospitals protocols. (Six of the crucial indicators were described in less than 50% of the local protocols.) CONCLUSIONS: The data from this review imply incompleteness of the local Dutch protocols. Improvement of the protocols can result in improvement of implementation and subsequent improvement of quality care for pregnant women with hypertension finally resulting in better outcome of mother and child.