Intrapartum-related perinatal deaths in births planned in midwifery-led settings in Great Britain: findings and recommendations from the ESMiE confidential enquiry.

OBJECTIVE: To review quality of care in births planned in midwifery-led settings, resulting in an intrapartum-related perinatal death. DESIGN: Confidential enquiry. SETTING: England, Scotland and Wales. SAMPLE: Intrapartum stillbirths and intrapartum-related neonatal deaths in births planned in alongside midwifery units, freestanding midwifery units or at home, sampled from national perinatal surveillance data for 2015/16 (alongside midwifery units) and 2013-16 (freestanding midwifery units and home births). METHODS: Multidisciplinary panels reviewed medical notes for each death, assessing and grading quality of care by consensus, with reference to national standards and guidance. Data were analysed using thematic analysis and descriptive statistics. RESULTS: Sixty-four deaths were reviewed, 30 stillbirths and 34 neonatal deaths. At the start of labour care, 23 women were planning birth in an alongside midwifery unit, 26 in a freestanding midwifery unit and 15 at home. In 75% of deaths, improvements in care were identified that may have made a difference to the outcome for the baby. Improvements in care were identified that may have made a difference to the mother's physical and psychological health and wellbeing in 75% of deaths. Issues with care were identified around risk assessment and decisions about planning place of birth, intermittent auscultation, transfer during labour, resuscitation and neonatal transfer, follow up and local review. CONCLUSIONS: These confidential enquiry findings do not address the overall safety of midwifery-led settings for healthy women with straightforward pregnancies, but suggest areas where the safety of care can be improved. Maternity services should review their care with respect to our recommendations. TWEETABLE ABSTRACT: Confidential enquiry of intrapartum-related baby deaths highlights areas where care in midwifery-led settings can be made even safer.

The incidence, characteristics, management and outcomes of anaphylaxis in pregnancy: a population-based descriptive study.

OBJECTIVE: The aim of this study was to estimate the incidence of anaphylaxis in pregnancy and describe the management and outcomes in the UK. DESIGN: A population-based descriptive study using the UK Obstetric Surveillance System (UKOSS). SETTING: All consultant-led maternity units in the UK. POPULATION: All pregnant women who had anaphylaxis between 1 October 2012 and 30 September 2015. Anaphylaxis was defined as a severe, life-threatening generalised or systemic hypersensitivity reaction. METHODS: Prospective case notification using UKOSS. MAIN OUTCOME MEASURES: Maternal mortality, severe maternal morbidity, neonatal mortality and severe neonatal morbidity. RESULTS: There were 37 confirmed cases of anaphylaxis in pregnancy, giving an estimated incidence of 1.6 (95% CI: 1.1-2.2) per 100 000 maternities. Four cases of anaphylaxis were in women with known penicillin allergies: two received co-amoxiclav and two cephalosporins. Twelve women had anaphylaxis following prophylactic use of antibiotics at the time of a caesarean delivery. Prophylactic use of antibiotics for Group B streptococcal infection accounted for anaphylaxis in one woman. Two women died (5%), 14 (38%) women were admitted to intensive care and seven women (19%) had one or more additional severe maternal morbidities, which included three haemorrhagic events, two cardiac arrests, one thrombotic event and one pneumonia. No infants died; however, in those infants whose mother had anaphylaxis before delivery (n = 18) there were seven (41%) neonatal intensive care unit admissions, three preterm births and one baby was cooled for neonatal encephalopathy. CONCLUSIONS: Anaphylaxis is a rare severe complication of pregnancy and frequently the result of a reaction to antibiotic administration. This study highlights the seriousness of the outcomes of this condition for the mother. The low incidence is reassuring given the large proportion of the pregnant population that receive prophylactic antibiotics during delivery. TWEETABLE ABSTRACT: Anaphylaxis is a rare severe complication of pregnancy and frequently the result of a reaction to antibiotic administration.

Ethnic differences in the clustering and outcomes of health behaviours during pregnancy: results from the Born in Bradford cohort.

Background: Pregnancy is a time of optimal motivation for many women to make positive behavioural changes. We aim to describe pregnant women with similar patterns of self-reported health behaviours and examine associations with birth outcomes. Methods: We examined the clustering of multiple health behaviours during pregnancy in the Born in Bradford cohort, including smoking physical inactivity, vitamin d supplementation and exposure to second-hand smoke. Latent class analysis was used to identify groups of individuals with similar patterns of health behaviours separately for White British (WB) and Pakistani mothers. Multinomial regression was then used to examine the association between group membership and birth outcomes, which included preterm birth and mean birthweight. Results: For WB mothers, offspring of those in the 'Unhealthiest' group had lower mean birthweight than those in the 'Mostly healthy but inactive' class, although no association was observed for preterm birth. For Pakistani mothers, group membership was not associated with birthweight differences, although the odds of preterm birth was higher in 'Inactive smokers' compared to the 'Mostly healthy but inactive' group. Conclusions: The use of latent class methods provides important information about the clustering of health behaviours which can be used to target population segments requiring behaviour change interventions considering multiple risk factors. Given the dominant negative association of smoking with the birth outcomes investigated, latent class groupings of other health behaviours may not confer additional risk information for these outcomes.

Pregnancy at very advanced maternal age: a UK population-based cohort study.

OBJECTIVES: To describe the characteristics, management and outcomes of women giving birth at advanced maternal age (≥48 years). DESIGN: Population-based cohort study using the UK Obstetric Surveillance System (UKOSS). SETTING: All UK hospitals with obstetrician-led maternity units. POPULATION: Women delivering at advanced maternal age (≥48 years) in the UK between July 2013 and June 2014 (n = 233) and 454 comparison women. METHODS: Cohort and comparison group identification through the UKOSS monthly mailing. MAIN OUTCOME MEASURES: Pregnancy complications. RESULTS: Older women were more likely than comparison women to be overweight (33% versus 23%, P = 0.0011) or obese (23% versus 19%, P = 0.0318), nulliparous (53% versus 44%, P = 0.0299), have pre-existing medical conditions (44% versus 28%, P < 0.0001), a multiple pregnancy (18% versus 2%, P < 0.0001), and conceived following assisted conception (78% versus 4%, P < 0.0001). Older women appeared more likely than comparison women to have pregnancy complications including gestational hypertensive disorders, gestational diabetes, postpartum haemorrhage, caesarean delivery, iatrogenic and spontaneous preterm delivery on univariable analysis and after adjustment for demographic and medical factors. However, adjustment for multiple pregnancy or use of assisted conception attenuated most effects, with significant associations remaining only with gestational diabetes (adjusted odds ratio [aOR] 4.81, 95% CI 1.93-12.00), caesarean delivery (aOR 2.78, 95% CI 1.44-5.37) and admission to an intensive care unit (aOR 33.53, 95% CI 2.73-412.24). CONCLUSIONS: Women giving birth at advanced maternal age have higher risks of a range of pregnancy complications. Many of the increased risks appear to be explained by multiple pregnancy or use of assisted conception. TWEETABLE ABSTRACT: The pregnancy complications in women giving birth aged 48 or over are mostly explained by multiple pregnancy.

Incidence, risk factors, management and outcomes of amniotic-fluid embolism: a population-based cohort and nested case-control study.

OBJECTIVE: To describe the incidence, risk factors, management and outcomes of amniotic-fluid embolism (AFE) over time. DESIGN: A population-based cohort and nested case-control study using the UK Obstetric Surveillance System (UKOSS). SETTING: All UK hospitals with obstetrician-led maternity units. POPULATION: All women diagnosed with AFE in the UK between February 2005 and January 2014 (n = 120) and 3839 control women. METHODS: Prospective case and control identification through UKOSS monthly mailing. MAIN OUTCOME MEASURES: Amniotic-fluid embolism, maternal death or permanent neurological injury. RESULTS: The total and fatal incidence of AFE, estimated as 1.7 and 0.3 per 100 000, respectively, showed no significant temporal trend over the study period and there was no notable temporal change in risk factors for AFE. Twenty-three women died (case fatality 19%) and seven (7%) of the surviving women had permanent neurological injury. Women who died or had permanent neurological injury were more likely to present with cardiac arrest (83% versus 33%, P < 0.001), be from ethnic-minority groups (adjusted odds ratio [OR] 2.85, 95% confidence interval [95% CI] 1.02-8.00), have had a hysterectomy (unadjusted OR 2.49, 95% CI 1.02-6.06), had a shorter time interval between the AFE event and when the hysterectomy was performed (median interval 77 minutes versus 248 minutes, P = 0.0315), and were less likely to receive cryoprecipitate (unadjusted OR 0.30, 95% CI 0.11-0.80). CONCLUSION: There is no evidence of a temporal change in the incidence of or risk factors for AFE. Further investigation is needed to establish whether earlier treatments can reverse the cascade of deterioration leading to severe outcomes.

Antenatal magnesium sulfate: Neuro-protection for preterm infants.

The neuro-protective effect of antenatal magnesium sulfate on very preterm infants has been demonstrated in good-quality randomised controlled trials and meta-analyses. Magnesium administered prior to preterm delivery crosses over to the foetal circulation and acts via several pathways to reduce perinatal neuronal damage. Meta-analysis of the trial data indicates that antenatal magnesium sulfate reduces the risk of cerebral palsy by one-third, and results in one fewer case in every 50 women treated. Treatment is associated with discomfort and flushing in some women, but maternal side-effects are mostly transient and manageable. Magnesium sulfate has also been found to be without any serious adverse consequences in newborn infants. Consensus recommendations and guidelines have been developed and implemented internationally, and endorsed by the UK Royal College of Obstetricians and Gynaecologists. However, magnesium sulfate for neuro-protection of very preterm infants has not yet become established widely in UK practice. Paediatricians, neonatologists and advocacy groups for preterm infants and their families could contribute to raising awareness and engage in dissemination activities and implementation initiatives to develop local protocols for adoption of this safe, effective and cost-effective intervention to reduce the burden of cerebral palsy in children born very preterm.

Small-for-gestational age and large-for-gestational age thresholds to predict infants at risk of adverse delivery and neonatal outcomes: are current charts adequate? An observational study from the Born in Bradford cohort.

OBJECTIVES: Construct an ethnic-specific chart and compare the prediction of adverse outcomes using this chart with the clinically recommended UK-WHO and customised birth weight charts using cut-offs for small-for-gestational age (SGA: birth weight <10th centile) and large-for-gestational age (LGA: birth weight >90th centile). DESIGN: Prospective cohort study. SETTING: Born in Bradford (BiB) study, UK. PARTICIPANTS: 3980 White British and 4448 Pakistani infants with complete data for gestational age, birth weight, ethnicity, maternal height, weight and parity. MAIN OUTCOME MEASURES: Prevalence of SGA and LGA, using the three charts and indicators of diagnostic utility (sensitivity, specificity and area under the receiver operating characteristic (AUROC)) of these chart-specific cut-offs to predict delivery and neonatal outcomes and a composite outcome. RESULTS: In White British and Pakistani infants, the prevalence of SGA and LGA differed depending on the chart used. Increased risk of SGA was observed when using the UK-WHO and customised charts as opposed to the ethnic-specific chart, while the opposite was apparent when classifying LGA infants. However, the predictive utility of all three charts to identify adverse clinical outcomes was poor, with only the prediction of shoulder dystocia achieving an AUROC>0.62 on all three charts. CONCLUSIONS: Despite being recommended in national clinical guidelines, the UK-WHO and customised birth weight charts perform poorly at identifying infants at risk of adverse neonatal outcomes. Being small or large may increase the risk of an adverse outcome; however, size alone is not sensitive or specific enough with current detection to be useful. However, a significant amount of missing data for some of the outcomes may have limited the power needed to determine true associations.

A comparison of South Asian specific and established BMI thresholds for determining obesity prevalence in pregnancy and predicting pregnancy complications: findings from the Born in Bradford cohort.

OBJECTIVE: To describe how maternal obesity prevalence varies by established international and South Asian specific body mass index (BMI) cut-offs in women of Pakistani origin and investigate whether different BMI thresholds can help to identify women at risk of adverse pregnancy and birth outcomes. DESIGN: Prospective bi-ethnic birth cohort study (the Born in Bradford (BiB) cohort). SETTING: Bradford, a deprived city in the North of the UK. PARTICIPANTS: A total of 8478 South Asian and White British pregnant women participated in the BiB cohort study. MAIN OUTCOME MEASURES: Maternal obesity prevalence; prevalence of known obesity-related adverse pregnancy outcomes: mode of birth, hypertensive disorders of pregnancy (HDP), gestational diabetes, macrosomia and pre-term births. RESULTS: Application of South Asian BMI cut-offs increased prevalence of obesity in Pakistani women from 18.8 (95% confidence interval (CI) 17.6-19.9) to 30.9% (95% CI 29.5-32.2). With the exception of pre-term births, there was a positive linear relationship between BMI and prevalence of adverse pregnancy and birth outcomes, across almost the whole BMI distribution. Risk of gestational diabetes and HDP increased more sharply in Pakistani women after a BMI threshold of at least 30 kg m(-2), but there was no evidence of a sharp increase in any risk factors at the new, lower thresholds suggested for use in South Asian women. BMI was a good single predictor of outcomes (area under the receiver operating curve: 0.596-0.685 for different outcomes); prediction was more discriminatory and accurate with BMI as a continuous variable than as a binary variable for any possible cut-off point. CONCLUSION: Applying the new South Asian threshold to pregnant women would markedly increase those who were referred for monitoring and lifestyle advice. However, our results suggest that lowering the BMI threshold in South Asian women would not improve the predictive ability for identifying those who were at risk of adverse pregnancy outcomes.

Maternal sepsis: a Scottish population-based case-control study.

OBJECTIVE: To describe the risk of maternal sepsis associated with obesity and other understudied risk factors such as operative vaginal delivery. DESIGN: Population-based, case-control study. SETTING: North NHS region of Scotland. POPULATION: All cases of pregnant, intrapartum and postpartum women with International Classification of Disease-9 codes for sepsis or severe sepsis recorded in the Aberdeen Maternal and Neonatal Databank (AMND) from 1986 to 2009. Four controls per case selected from the AMND were frequency matched on year-of-delivery. METHODS: Cases and controls were compared; significant variables from univariable regression were adjusted in a multivariable logistic regression model. MAIN OUTCOME MEASURES: Dependent variables were uncomplicated sepsis or severe ('near-miss') sepsis. Independent variables were demographic, medical and clinical delivery characteristics. Unadjusted and adjusted odds ratios (OR) with 95% confidence intervals (95% CI) are reported. RESULTS: Controlling for mode of delivery and demographic and clinical factors, obese women had twice the odds of uncomplicated sepsis (OR 2.12; 95% CI 1.14-3.89) compared with women of normal weight. Age <25 years (OR 5.15; 95% CI 2.43-10.90) and operative vaginal delivery (OR 2.20; 95% CI 1.02-4.87) were also significant predictors of sepsis. Known risk factors for maternal sepsis were also significant in this study (OR for uncomplicated and severe sepsis respectively): multiparity (OR 6.29, 12.04), anaemia (OR 3.43, 18.49), labour induction (OR 3.92 severe only), caesarean section (OR 3.23, 13.35), and preterm birth (OR 2.46 uncomplicated only). CONCLUSIONS: Obesity, operative vaginal delivery and age <25 years are significant risk factors for sepsis and should be considered in clinical obstetric care.

Measuring placental transfusion for term births: weighing babies with cord intact.

OBJECTIVE: To estimate the volume and duration of placental transfusion at term. DESIGN: Prospective observational study. SETTING: Maternity unit in Bradford, UK. POPULATION: Twenty-six term births. METHODS: Babies were weighed with umbilical cord intact using digital scales that record an average weight every 2 seconds. Placental transfusion was calculated from the change in weight between birth and either cord clamping or when weighing stopped. Start and end weights were estimated using both a B-spline and inspection of graphs. Weight was converted to volume, 1 ml of blood weighing 1.05 g. MAIN OUTCOME MEASURES: Volume and duration of placental transfusion. RESULTS: Twenty-six babies were weighed. Start weights were difficult to determine because of artefacts in the data as the baby was placed on the scales and wrapped. The mean difference in weight was 116 g [95% confidence interval (CI), 72-160 g] using the B-spline and 87 g (95% CI, 64-110 g) using inspection. Converting this to the mean volume of placental transfusion gave 110 ml (95% CI, 69-152 ml) and 83 ml (95% CI, 61-106 ml), respectively. Placental transfusion was usually complete by 2 minutes, but sometimes continued for up to 5 minutes. Based on the B-spline, placental transfusion contributed 32 ml (95% CI, 30-33 ml) per kilogram of birth weight to blood volume, but 24 ml (95% CI, 19-32 ml) based on inspection. This equates to 40% (95% CI, 37-42%) and 30% (24-40%), respectively, of total potential blood volume. CONCLUSION: Inspection of the graphs probably underestimates placental transfusion. For term infants, placental transfusion contributes between one-third and one-quarter of total potential blood volume at birth.

The importance of postpartum glucose tolerance testing after pregnancies complicated by gestational diabetes.

AIMS: To review postpartum glucose tolerance in women with gestational diabetes and evaluate the role of formal 75 g oral glucose tolerance testing vs. fasting plasma glucose in screening for persistent abnormalities. METHODS: Retrospective study of 985 pregnancies over a 10 year period in a mixed ethnic cohort of women who underwent follow-up glucose tolerance testing at 6 weeks postpartum. Diagnosis obtained by oral glucose tolerance test was tested against that from the fasting plasma glucose value. RESULTS: There were 272 abnormal postpartum oral glucose tolerance test results (27.6%), with 109 women identified as having frank diabetes. Eleven of these (10%) had fasting plasma glucose < or =6.0 mmol/l, as did 62 of 114 cases of impaired glucose tolerance. A fasting plasma glucose concentration of > or =6.1 mmol/l correctly identified abnormal glucose tolerance in 199 of 272 cases (sensitivity 0.73). South Asian women were much more likely to have persistent abnormalities of glucose tolerance than were Europeans (32 vs. 15%, chi(2)P < 0.0001). CONCLUSIONS: A postpartum fasting plasma glucose measurement alone is not sensitive enough in our population to classify glucose tolerance status accurately. A formal postpartum oral glucose tolerance test is therefore needed to facilitate early detection and treatment.

Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes.

BACKGROUND: Diabetes causes a rise in blood glucose above normal physiological levels causing damage to many systems including the cardiovascular and renal systems. Pregnancy causes a physiological reduction in insulin action; for those women who have pre-gestational diabetes, this results in an increasing insulin requirement. There are several methods of administering insulin. Conventionally, insulin has been administered subcutaneously, formally referred to as intensive conventional treatment, but now more usually referred to as multiple daily injections (MDI). An alternative insulin administration method is the continuous subcutaneous insulin infusion pump (CSII). OBJECTIVES: To compare continuous subcutaneous insulin infusion with MDI of insulin for pregnant women with diabetes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2006). SELECTION CRITERIA: Randomised controlled trials comparing CSII with MDI for pregnant women with diabetes. DATA COLLECTION AND ANALYSIS: Three authors independently assessed studies and extracted data. MAIN RESULTS: Two studies (60 women with 61 pregnancies) were included. There was a significant increase in mean birthweight associated with CSII as opposed to MDI (weighted mean difference 220.56, 95% confidence interval (CI) -2.09 to 443.20; two trials, 61 participants). However, taking into consideration the lack of significant difference in rate of macrosomia (birthweight greater than 4000 g) (relative risk (RR) 3.20, 95% CI 0.14 to 72.62; two trials, 61 participants), this is not viewed by the authors as clinically significant. No significant differences were found in any other outcomes measured, which may reflect the small number of trials suitable for meta-analysis and the small number of participants in the included studies. No significant differences were found in perinatal mortality (RR 2.00, 95% CI 0.20 to 19.91), fetal anomaly (RR 1.07, 95% CI 0.07 to 15.54), maternal hypoglycaemia (RR 3.00, 95% CI 0.35 to 25.87) or maternal hyperglycaemia (RR 7.00, 95% CI 0.39 to 125.44). AUTHORS' CONCLUSIONS: There is a dearth of robust evidence to support the use of one particular form of insulin administration over another for pregnant women with diabetes. The data are limited because of the small number of trials appropriate for meta-analysis, small study sample size and questionable generalisability of the trial population. Conclusions cannot be made from the data available and therefore a robust randomised trial is needed. The trial should be adequately powered to assess the efficacy of continuous subcutaneous insulin infusion versus multiple daily injections in terms of appropriate outcomes for women with diabetes.

In vitro susceptibilities in lymphocytes from mothers and cord blood to the monofunctional alkylating agent EMS.

It has been reported that children may experience different levels of chemical exposures than adults and that their sensitivities to chemical toxins may be increased or decreased when compared to adults. The perinatal period is one period in which these susceptibilities may be examined. Midwives at the Bradford Royal Infirmary collected venous blood samples from mothers at the time of birth and venous cord blood post-delivery. Lymphocytes were isolated from both blood types and examined in the alkaline comet assay using the monofunctional alkylating agent ethyl methanesulphonate (EMS). There were no biologically significant differences when subjects were categorized into subgroups based on lifestyle habits and physical characteristics, and overall there were no statistically significant differences in levels of DNA damage in mothers (n=22) and babies (n=22), except at the basal level (P<0.05), but mean values in babies were always lower over the EMS dose range. Whole blood was used in the micronucleus (MN) assay, and there was a significantly (P<0.05) higher rate of MN in mothers (n=17), per 1000 binucleates, as compared with lymphocytes from their offspring (n=17) at the basal level. This may be accounted for by age and endogenous factors. Overall, this current study cannot provide statistically significant evidence that children have either increased or decreased levels of susceptibility to a chemical toxin in comparison to adults when EMS is examined in vitro.

How long does a fetal scalp blood sample take?

The study aim was to identify the time from a decision to perform a fetal blood sample to the result of the test being available. A total of 100 consecutive fetal scalp blood samples taken on women in labour were identified from the blood gas analysers on the delivery suite. Eighty-nine percent of attempts yielded a result. The median time taken was 18 minutes (interquartile range 12-25 minutes). In 9% of women, the result took longer than 30 minutes. This is important clinically when repeated testing is required or in the second stage when operative vaginal delivery is achievable. Furthermore, when retrospectively analysing cases with a poor outcome, the time to obtain a result needs to be taken into account when determining the time at which a baby could have been delivered.

United kingdom amniotic fluid embolism register.

OBJECTIVE: The United Kingdom Amniotic Fluid Embolism Register was established to identify the incidence of the condition and examine any differences or common factors between survivors and fatalities. DESIGN: An anonymous voluntary register. SETTING: The United Kingdom from 1997 to 2004. POPULATION: Any woman with a clinical diagnosis of amniotic fluid embolism. The entry criteria were as follows: acute hypotension or cardiac arrest, acute hypoxia and coagulopathy with onset during labour, caesarean section or within 30 minutes of delivery with no other clinical condition or potential explanation for the symptoms and signs. METHODS: A data collection form was completed after reporting. MAIN OUTCOME MEASURES: Mortality and morbidity rates in women and their babies. RESULTS: Of 66 cases, 44 had sufficient information to be included. Thirteen (29.5%; 95% CI 17-45%) women died. If the five extra deaths in the Confidential Enquiry into Maternal Death were included, the mortality would be 37% (95% CI 23-52%). Of the 31 survivors, 12 women had a cardiac arrest, 7 had a hysterectomy, 2 had further laparotomies, 1 had subglottic stenosis and 2 had persisting neurological impairment. Twenty-four of the 31 survivors were admitted to intensive care units. Of the 13 women who died, 7 of their babies survived. Four were acidotic at birth, of whom two developed hypoxic ischaemic encephalopathy (HIE) and one of these is known to have developed cerebral palsy. In 18 cases, the woman survived and the baby was alive and in utero at the time of the maternal collapse. Four of these died, four had HIE with one known to have developed cerebral palsy and one other was acidotic at birth. CONCLUSION: The mortality of amniotic fluid embolism is high but the majority of women will survive. There is significant maternal and neonatal morbidity even when the woman survives. Continuing assessment of cases of amniotic fluid embolism is important to identify ways of improving outcome.

Outcomes of severe pre-eclampsia/eclampsia in Yorkshire 1999/2003.

OBJECTIVE: To establish the risk of serious complications from severe pre-eclampsia and eclampsia in a region using a common guideline for the management of these conditions. DESIGN: A five-year prospective study. SETTING: Sixteen maternity units in Yorkshire. POPULATION: All women managed with severe pre-eclampsia and eclampsia. METHODS: A common guideline was developed for the management of women with these conditions. A network of midwives prospectively collected outcome data. MAIN OUTCOME MEASURE: Incidence of the conditions and serious complication rates. RESULTS: A total of 210,631 women delivered in the 16 units between 1 January 1999 and 31 December 2003. One thousand eighty-seven women were diagnosed with severe pre-eclampsia or eclampsia (5.2/1000). One hundred and fifty-one women had serious complications including 82 women (39/10,000) having eclamptic seizures and 49 women (23/10,000) requiring ICU admission. There were no maternal deaths but 54 out of 1145 babies died before discharge, giving a mortality rate of 47.2/1000. Of the 82 cases of eclampsia, 45 occurred antenatally (55%), 18 before admission to the maternity unit. Eleven cases occurred in labour (13%), including 1 during a caesarean section, and 26 cases occurred following delivery (32%). Twenty-five women developed pulmonary oedema (2.3% of cases) and six women required renal dialysis (0.55% of cases). One hundred and sixty-five (15%) required no antihypertensive therapy and 489 (53%) of the remainder required only oral therapy. Two hundred and one (18.5%) required more than one drug. CONCLUSION: A regional guideline for severe pre-eclampsia and eclampsia can be developed and implemented. Its use may contribute to a low rate of serious complications.

Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol.

BACKGROUND: The conventional view that participants in randomised controlled trials sacrifice themselves for the good of future patients is challenged by increasing evidence to suggest that individual patients benefit from participation in trials. OBJECTIVE: To test the hypothesis that trial participants receive higher quality care and, as a consequence, have better outcomes than patients receiving guideline driven routine care. METHODS: Retrospective comparative study of 408 women with pre-eclampsia all managed according to a strict protocol. Trial participants were 86 women who participated in a multicentre randomised controlled trial of magnesium sulphate for the treatment of pre-eclampsia (Magpie Trial); 322 non-participants formed the control group. Indicators of the process of care and clinical outcomes were compared between the two groups. RESULTS: Trial participants were significantly more likely to have received daily blood tests (odds ratio (OR) 6.82, 95% CI 1.62 to 28.72) and had their respiration rate measured hourly (OR 3.42, 95% CI 1.69 to 6.92) than control patients. There were no significant differences in other markers of clinical process and no significant difference in clinical outcomes. CONCLUSION: This study shows minor differences in process markers and no difference in clinical outcomes between patients in a clinical trial and patients receiving protocol driven care. The benefits of improved clinical care that have previously been associated with being in a trial may be explained by the use of clear clinical protocols. In routine practice, patients may be well advised to insist on treatment as part of a protocol.