Reporting of gestational diabetes and other maternal medical conditions: validation of routinely collected hospital data from New South Wales, Australia.

INTRODUCTION: Hospital datasets are a valuable resource for examining prevalence and outcomes of medical conditions during pregnancy. To enable effective research and health planning, it is important to determine whether variables are reliably captured. OBJECTIVE: To examine the reliability of reporting of gestational and pre-existing diabetes, hypertension, thyroid conditions, and morbid obesity in coded hospital records that inform the population-level New South Wales Admitted Patient Data Collection. METHODS: Coded hospital admission data from two large tertiary hospitals in New South Wales, from 2011 to 2015, were compared with obstetric data, collected by midwives at outpatient pregnancy booking and in hospital after birth, as the reference standard. Records were deterministically linked and sensitivity, specificity, positive predictive values and negative predictive values for the conditions of interest were obtained. RESULTS: There were 36,051 births included in the analysis. Sensitivity was high for gestational diabetes (83.6%, 95% CI 82.4-84.7%), pre-existing diabetes (88.2%, 95% CI 84.1-91.6%), and gestational hypertension (80.1%, 95% CI 78.2-81.9%), moderate for chronic hypertension (53.5%, 95% CI 47.8-59.1%), and low for thyroid conditions (12.9%, 95% CI 11.7-14.2%) and morbid obesity (9.8%, 95% CI 7.6-12.4%). Specificity was high for all conditions (≥97.8%, 95% CI 97.7-98.0) and positive predictive value ranged from 53.2% for chronic hypertension (95% CI 47.5-58.8%) to 92.7% for gestational diabetes (95% CI 91.8-93.5%). CONCLUSION: Our findings suggest that coded hospital data are a reliable source of information for gestational and pre-existing diabetes and gestational hypertension. Chronic hypertension is less consistently reported, which may be remedied by grouping hypertension types. Data on thyroid conditions and morbid obesity should be used with caution, and if possible, other sources of data for those conditions should be sought.

Validation of anaemia, haemorrhage and blood disorder reporting in hospital data in New South Wales, Australia.

OBJECTIVE: Hospital data are a useful resource for studying pregnancy complications, including bleeding-related conditions, however, the reliability of these data is unclear. This study aims to examine reliability of reporting of bleeding-related conditions, including anaemia, obstetric haemorrhage and blood disorders, and procedures, such as blood transfusion and hysterectomy, in coded hospital records compared with obstetric data from two large tertiary hospitals in New South Wales. RESULTS: There were 36,051 births between 2011 and 2015 included in the analysis. Anaemia and blood disorders were poorly reported in the hospital data, with sensitivity ranging from 2.5% to 24.8% (positive predictive value (PPV) 12.0-82.6%). Reporting of postpartum haemorrhage, transfusion and hysterectomy showed high sensitivity (82.8-96.0%, PPV 78.0-89.6%) while moderate consistency with the obstetric data was observed for other types of obstetric haemorrhage (sensitivity: 41.9-65.1%, PPV: 50.0-56.8%) and placental complications (sensitivity: 68.2-81.3%, PPV: 20.3-72.3%). Our findings suggest that hospital data may be a reliable source of information on postpartum haemorrhage, transfusion and hysterectomy. However, they highlight the need for caution for studies of anaemia and blood disorders, given high rates of uncoded and 'false' cases, and suggest that other sources of data should be sought where possible.

Treatment of vaginal candidiasis for the prevention of preterm birth: a systematic review and meta-analysis.

BACKGROUND: Recognition that ascending infection leads to preterm birth has led to a number of studies that have evaluated the treatment of vaginal infections in pregnancy to reduce preterm birth rates. However, the role of candidiasis is relatively unexplored. Our aim was to undertake a systematic review and meta-analysis to assess whether treatment of pregnant women with vulvovaginal candidiasis reduces preterm birth rates and other adverse birth outcomes. METHODS: We undertook a systematic review and meta-analysis of published randomised controlled trials (RCTs) in which pregnant women were treated for vulvovaginal candidiasis (compared to placebo or no treatment) and where preterm birth was reported as an outcome. Trials were identified by searching the Cochrane Central Register of Controlled Trials, Medline and Embase databases to January 2014. Trial eligibility and outcomes were pre-specified. Two reviewers independently assessed the studies against the agreed criteria and extracted relevant data using a standard data extraction form. Meta-analysis was used to calculate pooled rate ratios (RR) and 95% confidence intervals (CI) using a fixed-effects model. RESULTS: There were two eligible RCTs both among women with asymptomatic candidiasis, with a total of 685 women randomised. Both trials compared treatment with usual care (no screening for, or treatment of, asymptomatic candidiasis). Data from one trial involved a post-hoc subgroup analysis (n = 586) of a larger trial of treatment of 4,429 women with asymptomatic infections in pregnancy and the other was a pilot study (n = 99). There was a significant reduction in spontaneous preterm births in treated compared with untreated women (meta-analysis RR = 0.36, 95% CI = 0.17 to 0.75). Other outcomes were reported by one or neither trial. CONCLUSIONS: This systematic review found two trials comparing the treatment of asymptomatic vaginal candidiasis in pregnancy for the outcome of preterm birth. Although the effect estimate suggests that treatment of asymptomatic candidiasis may reduce the risk of preterm birth, the result needs to be interpreted with caution as the primary driver for the pooled estimate comes from a post-hoc (unplanned) subgroup analysis. A prospective trial with sufficient power to answer the clinical question 'does treatment of asymptomatic candidiasis in early pregnancy prevent preterm birth' is warranted. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009241.

A survey of women and health providers about information regarding the timing of driving a car after experiencing a caesarean section.

BACKGROUND: In NSW, around 30% of women experience a caesarean section. Anecdotally, few receive consistent information regarding driving after a caesarean delivery. AIMS: The aims were to determine the information provided to women following caesarean section and by whom it was given, and compare this with women's actual driving behaviour. METHOD: Prior to hospital discharge, 101 consenting women completed a survey of five questions documenting the information they received about when to commence driving. They were telephoned 6-8 weeks postpartum and asked when they drove and whether they experienced any problems. Following this, a staff survey was conducted to establish what information was given to women. Insurance companies and government departments were contacted for relevant polices about when women can drive postcaesarean. RESULTS: 100 women completed both surveys (99% of recruits); 65% were advised to wait for 6 weeks or longer before driving. However, 72% of women reported they had driven by 6 weeks, and 35% by 3 weeks. In our sample, women reported minimal discomfort and rarely discontinued driving. Returned staff surveys (n = 138) revealed inconsistent advice ranging from no advice to 8 weeks of driving abstinence. Other recommendations included following insurance company guidelines (of which there were none specific to postcaesarean) (34%), 'listen to your body and be able to perform an emergency stop' (27%). CONCLUSION: Women receive conflicting advice, and current recommendations are not reflected in women's behaviour. Women are driving earlier than advised with minimal reported complications.

Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial.

BACKGROUND: Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth. METHODS: We used a prospective, randomized, open-label, blinded-endpoint (PROBE) study design. Pregnant women presenting at <20 weeks gestation with singleton pregnancies self-collected a vaginal swab. Those who were asymptomatic and culture positive for Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg) or usual care (screening result is not revealed, no treatment). The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth <37 weeks gestation was also assessed. RESULTS: Of 779 women approached, 500 (64%) participated in candidiasis screening, and 98 (19.6%) had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03. CONCLUSIONS: A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609001052224.

Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077].

BACKGROUND: Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases. METHODS/DESIGN: Using a prospective, randomised, open-label, blinded-endpoint (PROBE) study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care<20 weeks gestation with singleton pregnancies are eligible for inclusion. The intervention is a 6-day course of clotrimazole vaginal pessaries (100 mg) and the primary outcome is spontaneous preterm birth<37 weeks gestation.The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone) to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care). Outcomes will be obtained from population databases.A sample size of 3,208 women with Candida colonisation (1,604 per arm) is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8). Analyses will be by intention to treat. DISCUSSION: For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design.This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in pregnancy significantly reduces the rate of spontaneous preterm birth. If it can be demonstrated that treating asymptomatic candidiasis reduces preterm births this will change current practice and would directly impact the management of every pregnant woman. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000607077.