Client-rated facilitators and barriers to long-term youth anxiety disorder recovery.

OBJECTIVE: This study examined client ratings of 26 facilitators and barriers to anxiety improvement approximately 6 years after randomization to treatment for anxiety. METHOD: 319 youth (average 17.12 years old; 82.1% Caucasian; 58.6% female) participated in the longitudinal follow-up study to child and adolescent anxiety multimodal study (CAMS), a randomized controlled trial of medication, cognitive-behavioral therapy (CBT), combination, and placebo. RESULTS: Correcting for multiple comparisons, CBT components (i.e., problem solving, changing unhelpful thoughts, relaxation skills) were rated significantly more helpful among youth without, versus with, an anxiety disorder at follow-up. Barriers that differentiated youth with and without an anxiety disorder included being bullied and difficulty applying therapy content to new situations. Comparisons between youth with different anxiety disorder trajectories (e.g., stable remission, relapsed, or chronically ill) also revealed several differences. CONCLUSION: Findings suggest that client-rated facilitators and barriers covary with anxiety disorder recovery and may serve as useful tools when evaluating long-term treatment efficacy.

Common Elements of Childhood Universal Mental Health Programming.

Despite the availability of multiple mental health prevention and promotion programs for children, challenges related to their dissemination limit their reach and impact. This review identifies the most common practice elements of effective childhood universal mental health programming for children ages 3-11, based on a structured interpretation and coding of program manuals and descriptions in peer-reviewed articles. Across a range of program goals and targeted outcomes, psychoeducation and problem solving emerged as the most common practice elements, followed by social skills training, insight building, and communication skills. These skills were largely taught via role-plays and modeling. Synthesizing what we know from the universal mental health programming literature has potential to facilitate dissemination of information to inform the development, adaptation or adoption of programs for children.

Population attributable fractions of perinatal outcomes for nulliparous women associated with overweight and obesity, 1990-2014.

OBJECTIVE: To examine the prevalence across 25 years of overweight and obesity among nulliparous Australian women during early pregnancy; to estimate the proportions of adverse perinatal outcomes attributable to overweight and obesity in this population. DESIGN: Cohort study; retrospective analysis of electronic maternity data. Setting, participants: 42 582 nulliparous women with singleton pregnancies giving birth at the Royal Prince Alfred Hospital, an urban teaching hospital in Sydney, January 1990 - December 2014. MAIN OUTCOME MEASURES: Maternal body mass index (BMI), socio-demographic characteristics, and selected maternal, birth and neonatal outcomes; the proportion of adverse perinatal outcomes that could be averted by reducing the prevalence of overweight and obesity in women prior to first pregnancies (population attributable fraction, PAF). RESULTS: The prevalence of overweight among nulliparous pregnant women increased from 12.7% (1990-1994) to 16.4% (2010-2014); the prevalence of obesity rose from 4.8% to 7.3% in the same period, while the proportion with normal range BMIs fell from 73.5% to 68.2%. The PAFs for key adverse maternal and neonatal outcomes increased across the study period; during 2010-2014, 23.8% of pre-eclampsia, 23.4% of fetal macrosomia, and 17.0% of gestational diabetes were attributable to overweight and obesity. Were overweight and obese women to have moved down one BMI category during 2010-2014, 19% of pre-eclampsia, 15.9% of macrosomia, 14.2% of gestational diabetes, 8.5% of caesarean deliveries, 7.1% of low for gestational age birthweight, 6.8% of post partum haemorrhage, 6.5% of admissions to special care nursery, 5.8% of prematurity, and 3.8% of fetal abnormality could have been averted. CONCLUSIONS: Over the past 25 years, the proportions of adverse perinatal outcomes attributable to overweight and obesity have risen with the increasing prevalence of maternal overweight and obesity. A substantial proportion of these outcomes might be averted with obesity prevention strategies that reduce pre-pregnancy maternal weight.

Hypertension in pregnancy and long-term cardiovascular mortality: a retrospective cohort study.

BACKGROUND: There is growing evidence that hypertensive disorders of pregnancy are associated with increased long-term cardiovascular mortality in the mother. Hypertension in pregnancy, until recently, however, has been ignored largely as a risk factor for future cardiovascular disease and mortality because the link between the 2 is not fully understood. OBJECTIVE: To determine the association between women with hypertension in pregnancy and long-term cardiovascular disease mortality. STUDY DESIGN: All women who delivered at a metropolitan hospital between the periods of January 1, 1980, and December 31, 1989, were identified by use of the International Statistical Classification of Diseases and Related Health Problems, 9th Revision, Australian Modification. RESULTS: The total number of deliveries in the given time period was 31,656, with 4387 (14%) of the women identified as having had hypertension in their pregnancy. Using information from the New South Wales Births, Deaths and Marriages Registry and the Australian Bureau of Statistics Death Registry, we identified a total of 651 deaths from this cohort (n = 31,656). There were 521 deaths among the women who remained normotensive in their pregnancy and 129 deaths for women who had hypertension during their pregnancy. Overall, the women with hypertensive disorders of pregnancy were at greater risk of death than the women who remained normotensive in their pregnancy (odds ratio 1.56; 95% confidence interval 1.28-1.89; P < .001). CONCLUSION: Women with a history of hypertension in their pregnancy are at an increased risk of future cardiovascular mortality, and this work identifies a group of women who may benefit from early screening and intervention strategies to help decrease their risk of future cardiovascular disease.

Treatment of Primary Fetal Hydrothorax with OK-432 (Picibanil): Outcome in 14 Fetuses and a Review of the Literature.

BACKGROUND: Primary fetal hydrothorax (PFHT) is an uncommon condition with an estimated prevalence of 1 in 10,000/15,000 pregnancies. Therapeutic interventions include thoracocentesis, thoraco-amniotic shunting (TAS), and pleurodesis using OK-432. METHODS: A review of the literature was performed to identify all cases of PFHT treated with TAS and OK-432. All cases of PFHT referred to the Fetal Maternal Unit at Royal Prince Alfred Hospital between 2002 and 2012 were retrospectively reviewed. In the cohort of fetuses treated with OK-432, the main perinatal outcomes evaluated were termination of pregnancy, live birth, neonatal death, and fetal death in utero. Secondary outcomes included gestational age (GA) at diagnosis, GA at treatment, GA at resolution, birth weight, and GA at birth. The development of the children was screened using the Ages and Stages Questionnaires, Version 3 (ASQ-3, 2009). RESULTS: Primary hydrothorax was diagnosed in 31 fetuses, of which 14 had treatment with OK-432. One pregnancy terminated after treatment with OK-432. Survival was 85% (11/13): 100% in fetuses treated with OK-432 without hydrops, and 78% in those treated with hydrops. This compares well to the cases of TAS in the literature with an average survival of 63%: 85% in fetuses without hydrops and 55% with hydrops. The mean GA at birth was 36(+4) weeks and mean birth weight 3,007 g. Eight of the 9 children screened with ASQ-3 scored well within the normal range. CONCLUSION: OK-432 appears to be a valid treatment option in fetuses with PFHT, particularly in those diagnosed at early GAs.

Common elements of adolescent prevention programs: minimizing burden while maximizing reach.

A growing number of evidence-based youth prevention programs are available, but challenges related to dissemination and implementation limit their reach and impact. The current review identifies common elements across evidence-based prevention programs focused on the promotion of health-related outcomes in adolescents. We reviewed and coded descriptions of the programs for common practice and instructional elements. Problem-solving emerged as the most common practice element, followed by communication skills, and insight building. Psychoeducation, modeling, and role play emerged as the most common instructional elements. In light of significant comorbidity in poor outcomes for youth, and corresponding overlap in their underlying skills deficits, we propose that synthesizing the prevention literature using a common elements approach has the potential to yield novel information and inform prevention programming to minimize burden and maximize reach and impact for youth.

Maternal outcome after conservative management of placenta percreta at caesarean section: a report of three cases and a review of the literature.

Retaining the placenta in situ at caesarean section for placenta percreta and awaiting placental reabsorption is widely practiced; however, there is limited evidence on the efficacy and complications of this strategy. We present three cases of placenta percreta managed conservatively and note that all three women experienced significant complications. A review of the literature showed that despite initial conservative management, 40% of women subsequently require emergency hysterectomy and 42% will experience major morbidity.

Ultrasound assessment of cervical length at 18-21 weeks' gestation in an Australian obstetric population: comparison of transabdominal and transvaginal approaches.

BACKGROUND: Using a fixed cut-off of ≤25 mm, ultrasound assessment of cervical length during the 18-23 week anomaly scan has been shown to identify approximately 50% of pregnancies that would deliver prior to 34 weeks. AIM: To determine whether a policy of reverting to transvaginal cervical assessment only if the cervix appears short (≤25 mm) on transabdominal assessment affects the efficiency of screening. METHODS: Women with a singleton pregnancy that presented for a routine anomaly scan had their cervical length assessed transabdominally, initially with the maternal bladder full (TABF) and then empty (TABE). Cervical length was then assessed transvaginally (TV). RESULTS: One hundred and ninety-eight women agreed to participate in the study. Identification of the internal and external cervical os was possible during TABF, TABE and TV sonography in 97.0, 82.8 and 100%, respectively. Compared with TV sonography, TABF overestimates cervical length (6.1 mm difference in median values; P < 0.01). There was no significant difference between TV and TABE. However, TABE assessment was not possible in one in six women. If TABF sonography was to be used as a screening tool and using ≤25 mm as the critical cut-off, the sensitivity and specificity was 15.4 and 93.2%, respectively. CONCLUSION: This study has shown that assessment of cervical length using a TA approach is only routinely possible when the bladder is full. However, measurements are significantly overestimated. Therefore, we feel that TV assessment of cervical length is the preferred method of reliable cervical assessment. As such, all women should be offered a TV assessment of cervical length at the time of the fetal anomaly ultrasound as a screening test for preterm birth.

Tumor necrosis factor α induces a model of preeclampsia in pregnant baboons (Papio hamadryas).

Preeclampsia is a common disease of pregnancy characterised by maternal hypertension and proteinuria. Abnormal placentation in early pregnancy and abnormal cytokine and anti-angiogenic factor expression are thought to contribute to the clinical syndrome of endothelial dysfunction evident in the second half of gestation. The mechanisms underlying both the placental pathology and its translation to the maternal clinical syndrome are not fully understood. A model of preeclampsia manifest by clinically evident endothelial dysfunction (increased blood pressure and proteinuria) was induced by administration of low-dose TNF-α for 2weeks at mid-gestation in pregnant baboons (Papio hamadryas). Blood pressure was monitored continuously and remotely by intra-arterial radiotelemetry. Following TNF-α infusion, there was an increase in systolic and diastolic blood pressure and development of proteinuria in pregnant treated animals, but not in pregnant saline controls nor in non-pregnant TNF-α treated animals. The treated pregnant animals also developed elevated plasma soluble FMS-like tyrosine kinase-1 (sFLT-1) and increased placental mRNA expression of sFLT-1 and soluble endoglin (sEng). These results clearly demonstrate that the cytokine TNF-α can induce the clinical and biochemical features of human preeclampsia. The results identify a link between cytokines, placental dysfunction and endothelial dysfunction resulting in a loss of maternal blood pressure control.

Urinary placental growth factor differentiates the hypertensive disorders of pregnancy.

AIMS: To evaluate the discriminating capacity of urinary placental growth factor (uPlGF) for different hypertensive diseases of pregnancy during the third trimester. METHODS: A prospective descriptive case-control study conducted in an urban tertiary referral hospital and district general hospital, Sydney South West Area Health Service, Australia. Inpatients and outpatients with and without hypertension in the third trimester were recruited. Eligible patients provided a urine sample for protein, creatinine and a uPlGF level by ELISA. Patients were categorised into clinical hypertensive groups based on the diagnostic criteria of SOMANZ. RESULTS: Eighty-eight women were evaluated; 41 had hypertension (15 pre-eclampsia; 13 gestational hypertension; eight chronic hypertension; five pre-eclampsia superimposed on chronic hypertension) and 47 women without hypertension as the control group. There was a significant difference in uPlGF levels between the pre-eclamptic group (median 2.56 IQR 1.12-4.51) and the normotensive controls (median 13.18 IQR 5.95-31.39) (P < 0.0001); the gestational hypertensive group (median 3.74 IQR 2.49-4.91) and the normotensive group (median 13.18 IQR 5.95-31.39) (P=0.002) and for a subgroup comparison of placental-mediated hypertension (median 2.75 IQR 1.38-4.82) versus non-placental-mediated hypertensives (median 6.96 IQR 3.87-12.54) (P=0.007). CONCLUSIONS: Urinary placental growth factor is a simple non-invasive test, which is discriminatory for pre-eclampsia in the third trimester of pregnancy. Results from this study indicate that it may be discriminatory for hypertension related to placental dysfunction (pre-eclampsia and gestational hypertension) when compared with hypertension unrelated to placental function. Further work is required to assess the ability to detect hypertensive diseases before they are clinically apparent.

Normal ranges for fetal nasal bone length determined by ultrasound at 18-20 weeks of gestation in a multiethnic Australian population.

OBJECTIVE: Absence or hypoplasia of the nasal bone is commonly reported in Down syndrome fetuses. We define normal ranges and the 2.5th centile for fetal nasal bone length (NBL) in a multiethnic Australian population at 18-20 weeks of gestation. METHODS: A prospective cohort study of women attending for a routine anomaly scan. Ethnicity of the patient and their partner was recorded, and the nasal bone was measured three times. Two methods of nasal bone assessment were used to define normal ranges: a single (first) measurement and the mean value of three measurements. Mixed-effects regression models were employed to account for interoperator differences treating sonographers as random effects. Nonparametric methods were used to define the 2.5th centile for gestational age. RESULTS: A total of 1199 women were included with a mean gestational age 19.1 (SD 0.4; range 18-20) weeks. There is significant linear relationship between NBL and gestational age (P<0.001). The mean of three nasal bone measurements had a smaller standard deviation than single nasal bone measurements. Nonparametric assessment was used to define the 2.5th centile, which is 4.4 mm at 18 weeks and 5.0 mm at 20 weeks of gestation. CONCLUSIONS: This study provides a reference range for fetal NBL at 18-20 weeks of gestation in an unselected multiethnic Australian population. Whilst NBL increases linearly from 18 to 20 weeks, the data are not normally distributed and nonparametric techniques are required to define the 2.5th centile. The mixed-effects model also accounts for variation in sonographer measurements.

Pregnancy outcomes in the current era of cystic fibrosis care: a 15-year experience.

BACKGROUND: With improvement in clinical care and longer survival of patients with cystic fibrosis (CF), pregnancy has become commonplace. However, the impact of pregnancy on maternal health and fetal outcomes requires ongoing review. METHODS: A retrospective study of 20 pregnancies from 18 women with CF during the period 1995-2009 was performed. Changes in lung function, body mass index (BMI) and development of gestational diabetes were recorded. Fetal outcomes and maternal survival were examined, and the influence of pre-pregnancy parameters on outcomes was evaluated. RESULTS: Mean maternal age at pregnancy was 29±5 years with a mean pre-pregnancy forced expiratory volume in 1 s (FEV1) of 65.6±20.8% predicted. Eleven of 20 pregnancies had a pre-pregnancy FEV1 <60% predicted. During pregnancy, FEV1% predicted fell by 4.8% (CI 1.6-7.9), but recovered to baseline within 6 months post-partum. Mothers gained a mean weight of 7.6±3.2 kg, and gestational diabetes developed in 43% of women. All women delivered live births apart from one therapeutic abortion. Five infants were preterm, and two mature infants had low birth weight. Three mothers either died or required lung transplantation after pregnancy (range 2.5-8.0 years). FEV1 <60% predicted and BMI <20 kg/m(2) were significant predictors of fetal complications. CONCLUSION: Most women tolerated pregnancy well without major complications despite many having at least moderate lung function impairment. Pre-pregnancy FEV1 and BMI were important predictors of outcomes.

Genetic counselling issues in cystic fibrosis.

Cystic fibrosis is a chronic condition for which genetic testing offers much for the individuals affected in terms of an early diagnosis and offers timely additional information for families with regard to family planning and prenatal testing. Genetic counselling encompasses a range of clinical issues for families and forms a complementary resource for clinicians caring for people with cystic fibrosis. This review will discuss the range of genetic information readily available to patients and families through genetic counselling.

Pregnancy and cystic fibrosis.

The management of a pregnancy in a woman with cystic fibrosis is usually achieved with successful outcomes for mother and child with appropriate multidisciplinary care. The process begins prior to conception and requires frequent monitoring of the mother's respiratory status, level of glycaemic control and obstetric wellbeing. Recent reports have suggested that pregnancy can be managed without a persisting decrement in lung function beyond what may be expected in women with cystic fibrosis who are not pregnant. With the increasingly positive outcomes for people with cystic fibrosis, it is likely that more couples will chose to pursue pregnancy, cognisant of the risks and longer term issues for mother, child and family. This review will address the current issues in the management of pregnancy in women with cystic fibrosis.

Role of proteinuria in defining pre-eclampsia: clinical outcomes for women and babies.

1. The presence of proteinuria is not essential to the diagnosis of pre-eclampsia under many diagnostic consensus statements. The aim of the present study was to assess maternal and perinatal outcomes after proteinuric pre-eclampsia compared with other non-proteinuric disease presentations. 2. An individual patient data review (n = 670) was undertaken for 2003-2006 at a tertiary referral centre in Sydney (NSW, Australia). Women were diagnosed in accordance with the Australasian Society for the Study of Hypertension in Pregnancy Consensus Statement. Data were analysed with the Chi-squared test, t-tests and non-parametric tests. Statistical significance was set at P < 0.05. 3. The proteinuric cohort had higher systolic and diastolic blood pressure recordings than the non-proteinuric cohort (160/102 and 149/94 mmHg, respectively; P < 0.001), and were also administered magnesium sulphate more frequently (44 vs 22%, respectively; P < 0.001), delivered at earlier gestation (37 vs 38 weeks, respectively; P < 0.001), required operative delivery more frequently (63 vs 48%, respectively; P < 0.001) and received more antihypertensive medications during the antenatal period (72 vs 57%, respectively; P < 0.001). Acute renal failure and acute pulmonary oedema were rare. Four cases of eclampsia all occurred in non-proteinuric women. The perinatal mortality rate was lower for the offspring of women with proteinuric pre-eclampsia compared with offspring of non-proteinuric women (13/1000 and 31/1000, respectively; P = 0.006). 4. The results of the present study indicate that the presence of proteinuria denotes a group of women who have higher antenatal blood pressure, who deliver at earlier gestation and require operative delivery more commonly, although it is not an indicator of other markers of maternal morbidity or perinatal mortality.

Does the anti-hypertensive drug clonidine affect the short-term variation in CTG recordings?

BACKGROUND: Cardiotocographic (CTG) recordings of the fetal heart remain standard obstetric practice among hypertensive women. Changes in the short-term variation (STV) in the fetal heart are often attributed to the effect of anti-hypertensive medications, regardless of the fact that this principle has never been validated. AIM: To assess the STV of CTG recordings pre- and post- the anti-hypertensive medication, clonidine. METHODS: Forty hypertensive pregnant women, already receiving the anti-hypertensive clonidine, were recruited. The CTGs were conducted pre- and post-dose administration. The CTGs were assessed by the Sonicaid Team® automated CTG analysis (Oxford Instruments, UK) to avoid CTG assessor bias. Baseline fetal heart rate (FHR) (delta change from pre- and post-dose) and STV were compared using spss v.14® utilising Student t-tests. RESULTS: No statistical difference was found in the pre- and post-baseline FHRs (P = 0.48). The mean delta baseline heart rate before and after drug administration was -0.54 bpm. The STV of the CTGs recorded pre- and post-clonidine dose was also not affected by administration of the drug (P = 0.34). The mean delta STV before and after drug administration was 0.39 ms. Two women received betamethasone 12 mg intramuscularly within the 12-h period prior to CTG recordings to enhance fetal lung maturity. The mean STV for the fetuses of these women pre-drug was 4.8 ms and 13.2 ms post-administration. This was the largest delta seen in all STVs recorded in this dataset. CONCLUSION: The anti-hypertensive drug clonidine does not alter baseline FHRs or affect the STV of the FHR in hypertensive pregnant women.

A prospective cross-sectional study to define racial variation in fetal nasal bone length through ultrasound assessment at 18-20 weeks' gestation.

OBJECTIVE: An absent or short nasal bone is highly predictive of Down syndrome in Caucasian populations, but Asians may have shorter nasal bones - increasing the false positive rate of screening. We examine differences in nasal bone length (NBL) in Caucasian and Asian populations. METHODS: This prospective cohort study involved pregnant women attending for their routine anomaly scan at 18-20 weeks' gestation. Ethnicity of the patient and their partner was recorded, and the nasal bone was measured three times. Mean NBL was calculated and used to investigate the effect of ethnicity first with a simple linear regression model and second with a mixed-effects regression model that accounted for variability of measurement between sonographers. RESULTS: A total of 1087 families were involved in the study, including 592 (54%) Caucasians, 214 (20%) East Asians, 110 (10%) South Asians and 171 (16%) West Asians. Twenty-three sonographers performed the scans with an average of 19 scans each. There is no significant difference in NBL between Caucasian and Asian populations. The mixed-effects model shows that accounting for sonographer variation is important, with 6.7% of the total variance in measurement being related to this random effect. CONCLUSIONS: There is no significant difference in NBL between Caucasian and Asian populations. It is reasonable to use criteria established in a Caucasian population to define the characteristics of an absent/short nasal bone in Asian fetuses. This finding also removes difficulties in counselling mixed race couples.

Does Poverty Moderate Psychosocial Treatment Efficacy for ADHD? A Systematic Review.

Objective: To determine the extent to which children in poverty show differential benefit versus non-impoverished peers when undergoing behavioral treatment for ADHD. Method: Multiple readers conducted a systematic review using four research databases, one national treatment database, and multiple recent reviews and meta-analyses to identify appropriate studies. Results: Of 1192 initial search results, only five studies met inclusion criteria and were fully abstracted. Conclusion: Results suggest mixed evidence that low-income children may benefit less, compared with peers from higher income families, from psychosocial treatment for ADHD. Findings point to the need for more consistent, more precise, and higher quality reporting of income information.

Effect of hypoxia and exogenous IL-10 on the pro-inflammatory cytokine TNF-alpha and the anti-angiogenic molecule soluble Flt-1 in placental villous explants.

INTRODUCTION: The placenta plays a pivotal role in the pathophysiology of preeclampsia. Insufficient trophoblast invasion within the placenta can cause focal regions of ischaemia/hypoxia that, in turn, may stimulate the production of inflammatory cytokines. These cytokines are thought to cause endothelial cell activation and dysfunction, resulting in the clinical signs of preeclampsia. In addition to insufficient trophoblast invasion, the presence of inadequate maternal vasculature remodelling by trophoblasts also leads to changes in angiogenesis that may result from variations in the inflammatory cytokine profile. AIMS: This study examined changes in the protein levels of IL-10 (immunoregulatory), TNF-alpha (pro-inflammatory) and sFlt-1 (anti-angiogenic) in normal term placentas under different oxygen tensions. The second aim was to determine if the link between varying levels of the cytokine, IL-10, and the expression/release of TNF-alpha was oxygen dependent, and whether there was a concurrent change in sFlt-1. METHODS: Normal term placentas (n=6) were cultured at three different oxygen tensions (2%, 8% or 21%) in the presence or absence of exogenous IL-10. Protein (TNF-alpha and sFlt-1) secretion was measured using commercial ELISA kits, and qRT-PCR was used to examine gene expression. RESULTS: Placental IL-10 release was significantly reduced at 2% oxygen when compared to 8% (p=0.045) and 21% (p=0.013). Expression of TNF-alpha and sFlt-1 was not significantly different. Exogenous IL-10 significantly reduced TNF-alpha protein levels only when explants were cultured in 2% oxygen (p=0.05). Soluble Flt-1 protein secretion was unaffected by the addition of IL-10 at any of the oxygen tensions tested. CONCLUSION: TNF-alpha release can be inhibited in vitro by IL-10 under hypoxic conditions. However, IL-10 has no affect on sFlt-1 in term placentas, suggesting that these molecules act either via different pathways, or if linked, may be so at different stages of placental development.

Recombinant activated factor VII in obstetric hemorrhage: experiences from the Australian and New Zealand Haemostasis Registry.

OBJECTIVE: Through the Australian and New Zealand Haemostasis Registry, we report on the Australian and New Zealand experience with recombinant activated factor VII (rFVIIa) in obstetric patients. METHODS: The role of rFVIIa for off-label indications, including trauma, cardiac surgery, and severe postpartum hemorrhage, remains controversial. The Haemostasis Registry established by Monash University in Melbourne, Australia monitors off-label use of rFVIIa across Australia and New Zealand. The purpose of this study was to summarize Registry data for all obstetric hemorrhage patients treated with rFVIIa at participating hospitals between January 2002 and July 2008. The primary outcome measures were reduction or cessation of bleeding (positive therapeutic response), mortality, and hysterectomy rate. RESULTS: During the study period, the Registry received data for 2128 patients. This included 110 cases of administration of rFVIIa in obstetric patients from 38 hospitals, comprising 5% of the total Registry population, 105 of whom were treated for acute hemorrhage. Women received median (interquartile range) individual doses of 92 microg/kg (73-100) of rFVIIa (median total dose 92 microg/kg [58-108]), and 78% of patients received a single dose. The positive response rate to rFVIIa was 76% with 64% responding to the first dose. Ninety-one percent of women were alive at 28 days. Forty-three women (41%) underwent hysterectomy before receiving rFVIIa and, of those remaining, 13 (21%) required hysterectomy after rFVIIa therapy. Two thromboembolic events (1 pulmonary embolism and 1 deep venous thrombosis) and 1 case of hypoxic-ischemic encephalopathy resulting from severe anoxia were reported. CONCLUSIONS: The reported effect of rFVIIa in many, but not all, obstetric cases was positive. There was no mortality as a result of thromboembolic complications. Randomized, controlled trials are required to confirm its safety and efficacy and to assess the possibility that use at an earlier stage in treatment of severe postpartum hemorrhage may avoid the need to resort to postpartum hysterectomy for control of bleeding, thus preserving fertility.