CORONIS - International study of caesarean section surgical techniques: the follow-up study.

BACKGROUND: The CORONIS Trial was a 2×2×2×2×2 non-regular, fractional, factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes, the primary outcome being a composite of maternal death or infectious morbidity. The consequences of different surgical techniques on longer term outcomes have not been well assessed in previous studies. Such outcomes include those related to subsequent pregnancy: mode of delivery; abnormal placentation (e.g. accreta); postpartum hysterectomy, as well as longer term pelvic problems: pain, urinary problems, infertility. The Coronis Follow-up Study aims to measure and compare the incidence of these outcomes between the randomised groups at around three years after women participated in the CORONIS Trial. METHODS/DESIGN: This study will assess the following null hypotheses: In women who underwent delivery by caesarean section, no differences will be detected with respect to a range of long-term outcomes when comparing the following five pairs of alternative surgical techniques evaluated in the CORONIS Trial: 1. Blunt versus sharp abdominal entry. 2. Exteriorisation of the uterus for repair versus intra-abdominal repair. 3. Single versus double layer closure of the uterus. 4. Closure versus non-closure of the peritoneum (pelvic and parietal). 5. Chromic catgut versus Polyglactin-910 for uterine repair. The outcomes will include (1) women's health: pelvic pain; dysmenorrhoea; deep dyspareunia; urinary symptoms; laparoscopy; hysterectomy; tubal/ovarian surgery; abdominal hernias; bowel obstruction; infertility; death. (2) Outcomes of subsequent pregnancies: inter-pregnancy interval; pregnancy outcome; gestation at delivery; mode of delivery; pregnancy complications; surgery during or following delivery. DISCUSSION: The results of this follow-up study will have importance for all pregnant women and for health professionals who provide care for pregnant women. Although the results will have been collected in seven countries with limited health care resources (Argentina, Chile, Ghana, India, Kenya, Pakistan, Sudan) any differences in outcomes associated with different surgical techniques are likely to be generalisable throughout the world. TRIAL REGISTRATION: ISRCTN31089967.

Pregnancy in renal transplant recipients: a UK national cohort study.

BACKGROUND AND OBJECTIVES: Most reports of pregnancy outcome in women with kidney transplants are single-center, retrospective, and include small numbers and few are compared with controls. The aim of this study was to collect information about pregnancy outcomes among all kidney transplant recipients in the United Kingdom, managed with current antenatal and nephrologic care, and to compare these data with a contemporaneous control group. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Pregnant women with a kidney transplant were identified through the UK Obstetric Surveillance System (UKOSS) between January 1, 2007 and December 31, 2009. Data on a comparison cohort were obtained from the UKOSS database, containing information on comparison women identified in previous studies. Outcomes were also compared with national data. RESULTS: There were 105 pregnancies identified in 101 recipients. Median prepregnancy creatinine was 118 µmol/L. Preeclampsia developed in 24% compared with 4% of the comparison group. Median gestation at delivery was 36 weeks, with 52% of women delivering at <37 weeks, significantly higher than the national rate of 8%. Twenty-four infants (24%) were small for gestational age (<10th centile). There were two (2%) cases of acute rejection. Potential predictive factors for poor pregnancy outcome included >1 previous kidney transplant (P=0.03), first trimester serum creatinine >125 µmol/L (P=0.001), and diastolic BP >90 mmHg in the second (P=0.002) and third trimesters (P=0.05). CONCLUSIONS: Most pregnancies in the United Kingdom in women with kidney transplants are successful but rates of maternal and neonatal complications remain high.

Antenatal management and outcomes of gastroschisis in the U.K.

BACKGROUND: The birth prevalence of gastroschisis is increasing worldwide, yet little evidence exists concerning the optimal monitoring strategies after diagnosis. The aim of this study was to describe the U.K. prevalence, antenatal management and outcomes of affected pregnancies. METHODS: Cases were identified throughout the U.K. between October 2006 and September 2007, using three different sources. RESULTS: The overall birth prevalence of gastroschisis was 4.2 cases per 10, 000 total births (95% CI 3.6-4.8). Infants were variably monitored with growth scans (90%), umbilical artery Doppler ultrasound (85%), cardiotocography (65%) and biophysical profile (27%). Bowel measurements were undertaken for only 113 infants (52%). Eighty-nine women (43%) were induced and 63 (31%) laboured spontaneously. Eleven women (5%) had an elective caesarean delivery where the sole indication was fetal gastroschisis. CONCLUSIONS: The variability in management and paucity of evidence on antenatal monitoring approaches suggests there may be a place for randomised trials of fetal surveillance strategies in order to develop the evidence to improve outcomes for the at-risk fetus with gastroschisis. This study suggests that case ascertainment by regional congenital anomaly registers is high; extension of the coverage of these registers to the entire cohort of U.K. births would facilitate ongoing surveillance and research.

Incidence, risk factors, management, and outcomes of stroke in pregnancy.

OBJECTIVE: To estimate the incidence of antenatal stroke in the United Kingdom and to describe risk factors associated with stroke during pregnancy, management, and outcomes. METHODS: A population-based (nationwide) cohort and nested case-control study was conducted using the UK Obstetric Surveillance System between October 2007 and March 2010. We investigated the potential factors associated with antenatal stroke using a logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Thirty cases of antenatal stroke were reported giving an estimated incidence of 1.5 cases per 100,000 women delivering (95% CI 1.0-2.1). The incidences of nonhemorrhagic and hemorrhagic stroke were 0.9 (95% CI 0.5-1.3) and 0.6 (95% CI 0.3-1.0) per 100,000 women delivering. Factors associated with increased risk of antenatal stroke were history of migraine (adjusted OR 8.5, 95% CI 1.5-62.1), gestational diabetes (adjusted OR 26.8, 95% CI 3.2-∞), and preeclampsia or eclampsia (adjusted OR 7.7, 95% CI 1.3-55.7). There was wide variation in the use of pharmacologic, surgical, and organized stroke unit care. There were six stroke-related maternal deaths giving a case-fatality rate of 20% of all strokes, 50% of hemorrhagic strokes, and a mortality rate of 0.3 (95% CI 0.1-0.6) per 100,000 women delivering. CONCLUSION: The risk of a stroke during pregnancy is low; however, the poor outcomes in terms of morbidity and mortality and variations in care highlight the importance of such women receiving specialist stroke care. Clinicians should be aware of an association with a history of migraine, gestational diabetes, and preeclampsia or eclampsia. LEVEL OF EVIDENCE: II.

Uterine rupture by intended mode of delivery in the UK: a national case-control study.

BACKGROUND: Recent reports of the risk of morbidity due to uterine rupture are thought to have contributed in some countries to a decrease in the number of women attempting a vaginal birth after caesarean section. The aims of this study were to estimate the incidence of true uterine rupture in the UK and to investigate and quantify the associated risk factors and outcomes, on the basis of intended mode of delivery. METHODS AND FINDINGS: A UK national case-control study was undertaken between April 2009 and April 2010. The participants comprised 159 women with uterine rupture and 448 control women with a previous caesarean delivery. The estimated incidence of uterine rupture was 0.2 per 1,000 maternities overall; 2.1 and 0.3 per 1,000 maternities in women with a previous caesarean delivery planning vaginal or elective caesarean delivery, respectively. Amongst women with a previous caesarean delivery, odds of rupture were also increased in women who had ≥ two previous caesarean deliveries (adjusted odds ratio [aOR] 3.02, 95% CI 1.16-7.85) and <12 months since their last caesarean delivery (aOR 3.12, 95% CI 1.62-6.02). A higher risk of rupture with labour induction and oxytocin use was apparent (aOR 3.92, 95% CI 1.00-15.33). Two women with uterine rupture died (case fatality 1.3%, 95% CI 0.2-4.5%). There were 18 perinatal deaths associated with uterine rupture among 145 infants (perinatal mortality 124 per 1,000 total births, 95% CI 75-189). CONCLUSIONS: Although uterine rupture is associated with significant mortality and morbidity, even amongst women with a previous caesarean section planning a vaginal delivery, it is a rare occurrence. For women with a previous caesarean section, risk of uterine rupture increases with number of previous caesarean deliveries, a short interval since the last caesarean section, and labour induction and/or augmentation. These factors should be considered when counselling and managing the labour of women with a previous caesarean section.

Incidence and risk factors for placenta accreta/increta/percreta in the UK: a national case-control study.

BACKGROUND: Placenta accreta/increta/percreta is associated with major pregnancy complications and is thought to be becoming more common. The aims of this study were to estimate the incidence of placenta accreta/increta/percreta in the UK and to investigate and quantify the associated risk factors. METHODS: A national case-control study using the UK Obstetric Surveillance System was undertaken, including 134 women diagnosed with placenta accreta/increta/percreta between May 2010 and April 2011 and 256 control women. RESULTS: The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall; 577 per 10,000 in women with both a previous caesarean delivery and placenta praevia. Women who had a previous caesarean delivery (adjusted odds ratio (aOR) 14.41, 95%CI 5.63-36.85), other previous uterine surgery (aOR 3.40, 95%CI 1.30-8.91), an IVF pregnancy (aOR 32.13, 95%CI 2.03-509.23) and placenta praevia diagnosed antepartum (aOR 65.02, 95%CI 16.58-254.96) had raised odds of having placenta accreta/increta/percreta. There was also a raised odds of placenta accreta/increta/percreta associated with older maternal age in women without a previous caesarean delivery (aOR 1.30, 95%CI 1.13-1.50 for every one year increase in age). CONCLUSIONS: Women with both a prior caesarean delivery and placenta praevia have a high incidence of placenta accreta/increta/percreta. There is a need to maintain a high index of suspicion of abnormal placental invasion in such women and preparations for delivery should be made accordingly.

Gastroschisis: one year outcomes from national cohort study.

OBJECTIVE: To describe one year outcomes for a national cohort of infants with gastroschisis. DESIGN: Population based cohort study of all liveborn infants with gastroschisis born in the United Kingdom and Ireland from October 2006 to March 2008. SETTING: All 28 paediatric surgical centres in the UK and Ireland. PARTICIPANTS: 301 infants (77%) from an original cohort of 393. MAIN OUTCOME MEASURES: Duration of parenteral nutrition and stay in hospital; time to establish full enteral feeding; rates of intestinal failure, liver disease associated with intestinal failure, unplanned reoperation; case fatality. RESULTS: Compared with infants with simple gastroschisis (intact, uncompromised, continuous bowel), those with complex gastroschisis (bowel perforation, necrosis, or atresia) took longer to reach full enteral feeding (median difference 21 days, 95% confidence interval 9 to 39 days); required a longer duration of parenteral nutrition (median difference 25 days, 9 to 46 days) and a longer stay in hospital (median difference 57 days, 29 to 95 days); were more likely to develop intestinal failure (81% (25 infants) v 41% (102); relative risk 1.96, 1.56 to 2.46) and liver disease associated with intestinal failure (23% (7) v 4% (11); 5.13, 2.15 to 12.3); and were more likely to require unplanned reoperation (42% (13) v 10% (24); 4.39, 2.50 to 7.70). Compared with infants managed with primary fascial closure, those managed with preformed silos took longer to reach full enteral feeding (median difference 5 days, 1 to 9) and had an increased risk of intestinal failure (52% (50) v 32% (38); 1.61, 1.17 to 2.24). Event rates for the other outcomes were low, and there were no other significant differences between these management groups. Twelve infants died (4%). CONCLUSIONS: This nationally representative study provides a benchmark against which individual centres can measure outcome and performance. Stratifying neonates with gastroschisis into simple and complex groups reliably predicts outcome at one year. There is sufficient clinical equipoise concerning the initial management strategy to embark on a multicentre randomised controlled trial comparing primary fascial closure with preformed silos in infants suitable at presentation for either treatment to determine the optimal initial management strategy and define algorithms of care.

Perinatal outcomes after maternal 2009/H1N1 infection: national cohort study.

OBJECTIVES: To follow up a UK national cohort of women admitted to hospital with confirmed 2009/H1N1 influenza in pregnancy in order to obtain a complete picture of pregnancy outcomes and estimate the risks of adverse fetal and infant outcomes. DESIGN: National cohort study. SETTING: 221 hospitals with obstetrician led maternity units in the UK. PARTICIPANTS: 256 women admitted to hospital with confirmed 2009/H1N1 in pregnancy during the second wave of pandemic infection between September 2009 and January 2010; 1220 pregnant women for comparison. MAIN OUTCOME MEASURES: Rates of stillbirth, perinatal mortality, and neonatal mortality; odds ratios for infected versus comparison women. RESULTS: Perinatal mortality was higher in infants born to infected women (10 deaths among 256 infants; rate 39 (95% confidence interval 19 to 71) per 1000 total births) than in infants of uninfected women (9 deaths among 1233 infants; rate 7 (3 to 13) per 1000 total births) (P < 0.001). This was principally explained by an increase in the rate of stillbirth (27 per 1000 total births v 6 per 1000 total births; P = 0.001). Infants of infected women were also more likely to be born prematurely than were infants of comparison women (adjusted odds ratio 4.0, 95% confidence interval 2.7 to 5.9). Infected women who delivered preterm were more likely to be infected in their third trimester (P = 0.046), to have been admitted to an intensive care unit (P < 0.001), and to have a secondary pneumonia (P = 0.001) than were those who delivered at term. CONCLUSIONS: This study suggests an increase in the risk of poor outcomes of pregnancy in women infected with 2009/H1N1, which reinforces the message from studies of maternal risk alone. The health of pregnant women is an important public health priority in future waves of this and other influenza pandemics.

Maternal and obstetric factors associated with delayed postpartum eclampsia: a national study population.

OBJECTIVE: To estimate the incidence of delayed postpartum eclampsia and to investigate whether maternal characteristics and outcomes were different between women with delayed or early postpartum eclampsia. DESIGN: Prospective population-based study. SETTING: All 229 UK hospitals with consultant-led maternity units in the UK. POPULATION: All women delivering between February 2005 and February 2006. METHODS: Maternal characteristics and outcomes were compared between women with delayed (≥ 12 hours between delivery and eclampsia) and early postpartum eclampsia. MAIN OUTCOME MEASURES: Rates with 95% confidence intervals (CIs). Adjusted odds ratio estimates. RESULTS: Seventy-six women had postpartum eclampsia, representing an incidence of 1.0/10 000 (95% CI 0.7-1.2/10 000) maternities. Among the women having postpartum eclampsia, 53 (70%; 95% CI 59-79) occurred in the first 12 hours following delivery, eight (11%; 95% CI 3-20) during hours 12-24, four (5%; 95% CI 2-13) during the 24-48 hours after delivery and 11 (14%; 95% CI 7-24) more than 48 hours after delivery. Maternal characteristics, biological and clinical symptoms in the week preceding eclampsia and neonatal outcomes were not significantly different in the delayed eclampsia group in comparison with the early postpartum eclampsia group. However, the cesarean delivery rate was higher in women with delayed eclampsia in comparison with earlier postpartum eclampsia [13 (57%) vs. 6 (11%); odds ratio 10.1, 95% CI 3.12-33.3]. CONCLUSIONS: Close follow-up should be performed in the 12 hours following delivery in women with hypertensive disorders of pregnancy. Beyond this, the risk of eclampsia is very low, and eclampsia occurs mainly among women who have had a cesarean delivery.

Uterine compression sutures for the management of severe postpartum hemorrhage.

OBJECTIVE: To assess maternal outcomes after uterine compression suture use and to characterize the risk factors for failure, defined as cases that proceeded to hysterectomy. METHODS: A prospective population-based study of 1.2 million women delivering was conducted using the U.K. Obstetric Surveillance System to identify all women in the United Kingdom delivering between September 2007 and March 2009 and treated with uterine compression sutures. RESULTS: Two hundred eleven women were treated with a uterine compression suture to control postpartum hemorrhage. The overall rate of failure, leading to hysterectomy, was 25% (95% confidence interval, 19­31%); there were no significant differences in failure rates among B-Lynch sutures, modified B-Lynch sutures, and other suture techniques. Women were more likely to have a hysterectomy if they were aged 35 years or older (33% compared with 20% aged younger than 35 years), multiparous (33% compared with 14% in nulliparous), in unemployed and routine or manual occupational groups (28% compared with 17% in managerial or professional groups), had a vaginal delivery (47% compared with 22% in the cesarean delivery group), or a delay of between 2 and 6 hours from delivery to uterine suture compression (42% compared with 16% with delay less than 1 hour). CONCLUSION: A prolonged delay of 2­6 hours between delivery and uterine compression suture was independently associated with a fourfold increase in the odds of hysterectomy. These data emphasize the need for a careful evaluation of blood loss after delivery to avoid any prolonged delay in recognition of hemorrhage. LEVEL OF EVIDENCE: III

The incidence and outcomes of fetomaternal alloimmune thrombocytopenia: a UK national study using three data sources.

Fetomaternal alloimmune thrombocytopenia (FMAIT) is the most common cause of severe neonatal thrombocytopenia in otherwise well, term infants. First pregnancies are often severely affected. This descriptive, population-based national study was undertaken in order to inform the case for antenatal screening. Cases were identified using three sources and capture-recapture techniques used to generate a robust incidence estimate. One hundred and seventy three cases were identified between October 2006 and September 2008. An extra 20 cases were estimated from capture-recapture analysis, giving an estimated incidence of clinically detected FMAIT of 12·4 cases per 100 000 total births (95%confidence interval: 10·7, 14·3). Fifty-two cases (30%) were known at the start of pregnancy; 120 (70%) were unknown (n=115) or unrecognized (n=5). Unknown cases were more likely to experience a haemorrhagic complication (67% vs. 5%) (P<0·001) and more likely to have an intracranial haemorrhage (20% vs. 4%) (P=0·014) than known cases receiving antenatal management. In view of the incidence of severe disease identified, further assessment of the case for antenatal screening is important. There were a number of cases in which the significance of a history of FMAIT in a previous sibling was not recognized and there is a need to raise awareness of the importance of this diagnosis.

Gastroschisis: a national cohort study to describe contemporary surgical strategies and outcomes.

BACKGROUND: Information on adoption of newer surgical strategies for gastroschisis and their outcomes is largely limited to hospital-based studies. The aim of this study was to use a new UK national surveillance system to identify cases and thus to describe the contemporary surgical management and outcomes of gastroschisis. METHODS: We conducted a national cohort study using the British Association of Paediatric Surgeons Congenital Anomalies Surveillance System to identify cases between October 2006 and March 2008. RESULTS: All 28 surgical units in the United Kingdom and Ireland participated (100%). Data were received for 95% of notified cases of gastroschisis (n = 393). Three hundred thirty-six infants (85.5%) had simple gastroschisis; 45 infants (11.5%) had complex gastroschisis. For 12 infants (3.0%), the type of gastroschisis could not be categorized. Operative primary closure (n = 170, or 51%) and staged closure after a preformed silo (n = 120, or 36%) were the most commonly used intended techniques for simple gastroschisis. Outcomes for infants with complex gastroschisis were significantly poorer than for simple cases, although all deaths occurred in the simple group. CONCLUSIONS: This study provides a comprehensive picture of current UK practice in the surgical management of gastroschisis. Further follow-up data will help to elucidate additional prognostic factors and guide future research.

A novel use of a classification system to audit severe maternal morbidity.

OBJECTIVE: obstetric haemorrhage remains a significant cause of maternal morbidity and mortality worldwide and is significant in terms of patient safety and quality of care. One drastic outcome of haemorrhage is the need for peripartum hysterectomy. A classification system that can be used to audit severe events such as peripartum hysterectomy would be a useful adjunct to patient safety systems, but it would need to account for pre-existing risk factors, such as previous caesarean section. One system that accounts for important risk factors is the Robson Ten Group Classification System (TGCS). The aim of this study was to examine whether the TGCS could be extended in a novel way to classify who required peripartum hysterectomy. SETTING: population-based matched case-control study data from the UK Obstetric Surveillance System was used. All eligible UK hospitals participated. PARTICIPANTS: women who underwent peripartum hysterectomy between February 2005 and February 2006 and their matched controls. METHODS: cases and controls were categorised using the TGCS. The odds of having a peripartum hysterectomy in each classification group were calculated using logistic regression. An adjusted analysis was undertaken controlling for potential confounders. FINDINGS: 307 of the 315 women who had a peripartum hysterectomy were classified into one of the 10 groups; 606 of the 608 control women were classified. Women who underwent a peripartum hysterectomy were predominantly from the more complex classification groups. After adjusting for age, ethnicity and socio-economic status, the groups with an increased odds of peripartum hysterectomy were those who had a previous caesarean section. CONCLUSIONS: the TGCS can be used in a novel way, that is, to examine an outcome other than caesarean section, and could be part of a new system to monitor patient safety. Population-based data were used as an example of how an existing classification system could be used in a different way from that for which it was created, and could make comparisons across institutions and countries while adjusting for case mix in a simple manner. The TGCS may not necessarily be a useful way to monitor other events in childbirth. Further work is needed to develop other classification systems which could be used as a benchmarking tools to monitor patient safety in maternity care.

Incidence and risk factors for amniotic-fluid embolism.

OBJECTIVE: To estimate the incidence of amniotic-fluid embolism and to describe risk factors, management, and outcomes. METHODS: Through a population-based cohort study and nested case-control analysis, using the UK Obstetric Surveillance System, we identified 60 women in the United Kingdom who had an amniotic-fluid embolism between February 2005 and February 2009 and 1,227 women for the control group. We investigated the potential factors underlying amniotic-fluid embolism using an exploratory logistic regression analysis to estimate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Sixty cases of amniotic-fluid embolism were reported, an estimated incidence of 2.0 per 100,000 deliveries (95% CI 1.5-2.5). Amniotic-fluid embolism occurrence was significantly associated with induction of labor (adjusted OR 3.86, 95% CI 2.04-7.31) and multiple pregnancy (adjusted OR 10.9, 95% CI 2.81-42.7); an increased risk also was noted in older, ethnic-minority women (adjusted OR 9.85, 95% CI 3.57-27.2). Cesarean delivery was associated with postnatal amniotic-fluid embolism (adjusted OR 8.84, 95% CI 3.70-21.1). Twelve women died (case fatality 20%, 95% CI 11-32%); 5 of 37 newborns of women with antenatal amniotic-fluid embolism died (perinatal mortality 135 per 1,000 total births, 95% CI 45-288). Women who died were significantly more likely to be from ethnic-minority groups (adjusted OR 11.8, 95% CI 1.40-99.5). CONCLUSION: High-quality supportive care can result in good maternal outcomes after amniotic-fluid embolism. Clinicians should consider both the risks and benefits of induction and cesarean delivery because more restricted use may result in a decrease in the number of women suffering a potentially fatal amniotic-fluid embolism. The observed increased risk of fatality in ethnic-minority women may be associated with differences in underlying medical conditions or access to care, and clinicians should that ensure appropriate services are provided to minimize this risk.

Extreme obesity in pregnancy in the United Kingdom.

OBJECTIVE: To estimate the prevalence and describe on a national basis the management and outcomes of extreme obesity (body mass index [BMI] 50 kg/m or higher) in pregnancy in the United Kingdom. METHODS: A national cohort study was undertaken. Extremely obese women (BMI 50 or higher) and a comparison cohort were identified using the UK Obstetric Surveillance System. Prevalence estimates were calculated with 95% confidence intervals (CIs). Data for obese and comparison women were compared using the chi test or the Wilcoxon rank sum test. Odds ratios were estimated throughout using unconditional logistic regression. RESULTS: There were 665 women with extreme obesity in an estimated 764,387 women delivering, representing an estimated prevalence of 8.7 cases per 10,000 deliveries (95% CI 8.1-9.4). Extremely obese women had more complications than did comparison women, including preeclampsia (9% of women in the case group, 2% of those in the comparison group), gestational diabetes (11% of women in the case group, 2% of those in the comparison group), preterm delivery (10% of women in the case group, 7% of those in the comparison group), general anesthesia (6% of women in the case group, 1% of those in the comparison group), and intensive care unit admission (3% of women in the case group, 1% of those in the comparison group). Fifty percent of extremely obese women had cesarean deliveries compared with 22% of women in the comparison group. No women died. CONCLUSION: Nearly 1 in every 1,000 women giving birth in the United Kingdom is extremely obese. These women have increased risks of poor outcomes. Basic equipment was not universally available for the care of these women, and this, together with the increase in prevalence of obesity, has important implications for maternity service provision. There is an urgent need to address prepregnancy care and weight management programs to prevent this increase in prevalence, as well as to ensure that appropriate services are in place to reduce the inequalities in pregnancy outcomes for these women.

Magpie Trial in the UK: methods and additional data for women and children at 2 years following pregnancy complicated by pre-eclampsia.

BACKGROUND: The Magpie Trial, a randomised trial comparing magnesium sulphate with placebo for women with pre-eclampsia. This paper describes methods used for follow up in the UK, and presents additional data collected. METHODS: In the UK 774 women and their 827 children were included; excluded were women discharged without a surviving child and families who opted out. General practitioners were sent a questionnaire when the child was around 18 months old. When the child was two years, or older, questionnaires asking about the health of the women and children were posted to families. A sample of families was offered a home visit, during which the child was assessed using the Bayley Scales of Infant Development. RESULTS: Of the women, 12 were lost to follow up and three died. Of the children, 12 were lost to follow up, 5 were excluded and 19 died. General practitioners returned 688/759 (91%) questionnaires, as did 619/759 (82%) women. Responses were largely comparable. 32 women had serious morbidity potentially related to pre-eclampsia. 30% of children were reported to have been admitted to hospital. There were no clear differences between the randomised groups in the child's behaviour, women's fertility or use of health service resources. CONCLUSION: Data presented here provide further reassurance about the longer term safety of magnesium sulphate when used for women with pre-eclampsia. Postal questionnaires in the UK to assess the longer term health and wellbeing of women and children recruited to trials are feasible, and can achieve a high response rate. Responses from families and general practitioners were comparable

Inequalities in maternal health: national cohort study of ethnic variation in severe maternal morbidities.

OBJECTIVE: To describe on a national basis ethnic differences in severe maternal morbidity in the United Kingdom. DESIGN: National cohort study using the UK Obstetric Surveillance System (UKOSS). SETTING: All hospitals with consultant led maternity units in the UK. PARTICIPANTS: 686 women with severe maternal morbidity between February 2005 and February 2006. MAIN OUTCOME MEASURES: Rates, risk ratios, and odds ratios of severe maternal morbidity in different ethnic groups. RESULTS: 686 cases of severe maternal morbidity were reported in an estimated 775 186 maternities, representing an estimated incidence of 89 (95% confidence interval 82 to 95) cases per 100 000 maternities. 74% of women were white, and 26% were non-white. The estimated risk of severe maternal morbidity in white women was 80 cases per 100 000 maternities, and that in non-white women was 126 cases per 100,000 (risk difference 46 (27 to 66) cases per 100 000; risk ratio 1.58, 95% confidence interval 1.33 to 1.87). Black African women (risk difference 108 (18 to 197) cases per 100,000 maternities; risk ratio 2.35, 1.45 to 3.81) and black Caribbean women (risk difference 116 (59 to 172) cases per 100 000 maternities; risk ratio 2.45, 1.81 to 3.31) had the highest risk compared with white women. The risk in non-white women remained high after adjustment for differences in age, socioeconomic and smoking status, body mass index, and parity (odds ratio 1.50, 1.15 to 1.96). CONCLUSIONS: Severe maternal morbidity is significantly more common among non-white women than among white women in the UK, particularly in black African and Caribbean ethnic groups. This pattern is very similar to reported ethnic differences in maternal death rates. These differences may be due to the presence of pre-existing maternal medical factors or to factors related to care during pregnancy, labour, and birth; they are unlikely to be due to differences in age, socioeconomic or smoking status, body mass index, or parity. This highlights to clinicians and policy makers the importance of tailored maternity services and improved access to care for women from ethnic minorities. National information on the ethnicity of women giving birth in the UK is needed to enable ongoing accurate study of these inequalities.

Cesarean delivery and peripartum hysterectomy.

OBJECTIVE: To estimate the national incidence of peripartum hysterectomy and quantify the risk associated with cesarean deliveries and other factors. METHODS: A population-based, matched case-control study using the United Kingdom Obstetric Surveillance System, including 318 women in the United Kingdom who underwent peripartum hysterectomy between February 2005 and February 2006 and 614 matched control women. RESULTS: The incidence of peripartum hysterectomy was 4.1 cases per 10,000 births (95% confidence interval [CI] 3.6-4.5). Maternal mortality was 0.6% (95% CI 0-1.5%). Previous cesarean delivery (odds ratio [OR] 3.52, 95% CI 2.35-5.26), maternal age over 35 years (OR 2.42, 95% CI 1.66-3.58), parity of three or greater (OR 2.30, 95% CI 1.26-4.18), previous manual placental removal (OR 12.5, 95% CI 1.17-133.0), previous myomectomy (OR 14.0, 95% CI 1.31-149.3), and twin pregnancy (OR 6.30, 95% CI 1.73-23.0) were all risk factors for peripartum hysterectomy. The risk associated with previous cesarean delivery was higher with increasing numbers of previous cesarean deliveries (OR 2.14 with one previous delivery [95% CI 1.37-3.33], 18.6 with two or more [95% CI 7.67-45.4]). Women undergoing a first cesarean delivery in the current pregnancy were also at increased risk (OR 7.13, 95% CI 3.71-13.7). CONCLUSION: Peripartum hysterectomy is strongly associated with previous cesarean delivery, and the risk rises with increasing number of previous cesarean deliveries, maternal age over 35 years, and parity greater than 3. LEVEL OF EVIDENCE: II.

Evaluation of the Ages and Stages Questionnaires in identifying children with neurosensory disability in the Magpie Trial follow-up study.

AIM: To evaluate performance of the Ages and Stages Questionnaires (full ASQ), and a shortened version (short ASQ), in detecting children with severe neurosensory disability in the Magpie Trial follow-up study. METHODS: All children, born to women in the Magpie Trial and selected for follow-up, with a completed full 30 items and/or short 9-items ASQ were included in this analysis. Sensitivity and specificity, corrected for verification bias, were computed to assess detection ability. RESULTS: Of the 2046 children who completed a full ASQ, 406 (19.8%) failed the assessment, 54 of whom had confirmed neurosensory disability. Adjusted sensitivity and specificity (95% confidence intervals) were 87.4% (62.9-96.6%), and 82.3% (80.5-83.9%), respectively. Two of the five domains in the full ASQ (Fine Motor and Problem Solving) contributed little to detection ability. Sensitivity and specificity for the short ASQ were 69.2% and 95.7%, respectively. CONCLUSIONS: Sensitivity of the full ASQ for severe neurosensory disability is generally good, and does not appear to be much reduced by restricting questions to three out of the five domains. The short ASQ reported here reduced performance, although this might be improved by a different choice of questions or scoring system.