Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG) has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed.</p> <p>Methods/Design</p> <p>The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS) compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques.</p

Induction of labour versus expectant monitoring in women with pregnancy induced hypertension or mild preeclampsia at term: the HYPITAT trial

Contains fulltext : 53183.pdf ( ) (Open Access)BACKGROUND: Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to 15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates. METHODS/DESIGN: Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%. DISCUSSION: This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications. TRIAL REGISTRATION: The protocol is registered in the clinical trial register number ISRCTN08132825

Substandard care in maternal mortality due to hypertensive disease in pregnancy in the Netherlands

Objective To review the standard of care in cases of maternal mortality due to hypertensive diseases in pregnancy and to make recommendations for its improvement. Design Care given to women with hypertensive disease in pregnancy was audited and substandard care factors identified. Setting Confidential enquiry by the Dutch Maternal Mortality Committee (MMC) from the Netherlands Society of Obstetrics and Gynaecology. Population All maternal deaths reported to the MMC due to hypertensive disease in pregnancy in the Netherlands during the years 2000-04. Methods Assessment for substandard care factors using a checklist based on the Dutch guideline of 'Hypertensive Disorders in Pregnancy'. Main outcome measures Substandard care in cases of maternal mortality due to hypertensive diseases in pregnancy. Results A total of 27 cases of maternal death due to hypertensive disease in pregnancy were reported to the committee in the study period. In 26 cases (96%), substandard care factors were present, of which in 17 cases (63%), these were for more than five different items. In community midwifery care, the most frequent substandard care factor was no testing for proteinuria when clearly indicated (41%). In hospital care, the most frequent substandard care was related to insufficient diagnostic testing when indicated (41%), insufficient management of hypertension by obstetricians (85%), no use or inadequate use of magnesium sulphate (67%), inadequate stabilisation before transport to tertiary care centres and/or delivery (52%) and failure to consider timely delivery (44%). Conclusions Education of pregnant women concerning danger signs of hypertensive disease should be improved. Training of midwives and obstetricians should be improved in the following areas: performing basic diagnostic tests, adequate management of hypertension and eclampsia, with more attention to treatment of systolic blood pressure. This training should be guided by clear local protocols. Delivery should not be delayed in serious cases of hypertensive disease in pregnancy, not only after 32-34 weeks but also in early-onset pre-eclampsia as maternal risks often outweigh possible fetal benefits of temporising management

Indirect maternal mortality increases in the Netherlands

Objective. To assess causes, trends, and substandard care in indirect maternal mortality in the Netherlands. Design. Confidential enquiry into causes of maternal death. Setting. Nationwide in the Netherlands. Population. A total of 2,557,208 live births. Methods. Data analysis of indirect maternal deaths in the period 1993-2005. Main outcome measures. Indirect maternal mortality. Results. Of the study subjects, 97 were classified as indirect deaths, representing a maternal mortality ratio of 3.3/ 100,000 live births, a significant increase compared to the preceding enquiry in the period 1983-1992 (MMR 2.4, OR 1.5, 95% CI 1.0-2.1). The percentage of cases not directly reported to the Maternal Mortality Committee decreased from 15 to 5%. Cardiovascular disorders were the leading cause of indirect maternal mortality, followed by cerebrovascular disorders. Vascular dissection (n = 19) was the most frequent specified cause of death. Risk factors were advanced maternal age, non-indigenous origin (Surinam and Dutch Antilles), and medical health risks before pregnancy. Substandard care was present in 35%, mainly being misjudgment of the severity of the condition and delay in initiating therapy. Conclusion. The rise of mortality due to indirect causes is considered a reflection of the change in risk profile of women of childbearing age and the result of demographic alterations concerning ethnicity and maternal age. The identification of high risk groups, preferably by programs of preconception care, should lead to improved care for these women, with a multidisciplinary approach when needed

Maternal mortality and severe morbidity from sepsis in the Netherlands

Objective. To assess incidence and risk factors of maternal mortality and severe morbidity from sepsis in the Netherlands. Design. A nationwide confidential enquiry into maternal mortality from 1993 to 2006 and severe maternal morbidity from 2004 to 2006. Setting. All 98 Dutch maternity units in the Netherlands. Population. All pregnant women in the Netherlands from 1993 to 2006. Methods. All reported cases of maternal death from sepsis during 1993-2006 were reported to the Maternal Mortality Committee. Cases of severe maternal morbidity from sepsis from 2004 to 2006 were collected in a nationwide design. Main outcome measures. Incidence, case fatality rates, and possible risk factors. Results. The maternal mortality ratio from direct maternal mortality from sepsis was 0.73 per 100,000 live births (20/2,742,265). The incidence of severe maternal morbidity from sepsis was 21 per 100,000 deliveries (78/371,021), of which 79% was admitted to the intensive care unit. High age, multiple pregnancies, and the use of artificial reproduction techniques were significant risk factors for developing sepsis in univariate analysis. The overall case fatality rate for sepsis during 2004-2006 was 7.7% (6/78). Group A streptococcal infection was in 42.9% (9/21), the cause of direct maternal mortality from sepsis (1993-2006). In 31.8% (14/44), Group A streptococcal infection was the cause of obstetric morbidity from sepsis (2004-2006). Conclusions. With a case fatality rate of 7.7%, sepsis is a life threatening condition for women during pregnancy, childbirth, and puerperium

Quality indicator for obstetric care: development and use in the Netherlands

In deze studie is een set van 35 kwaliteitsindicatoren ontwikkeld voor de verloskundige zorg in het ziekenhuis. Deze indicatoren zijn gedurende zes maanden getest op bruikbaarheid in dertien ziekenhuizen. Uit de evaluatie blijkt dat de registratie haalbaar is en dat verdere implementatie van de indicatoren ondersteund wordt door de betrokken zorgverleners in het ziekenhuis. In de komende jaren wordt door de Nederlandse Vereniging voor Obstetrie en Gynaecologie (NVOG) gewerkt aan de implementatie van de set indicatoren om de kwaliteit van de obstetrische zorg in het ziekenhuis te stimuleren. Het doel van deze indicatoren is om gynaecologen een hulpmiddel te geven om de kwaliteit van de door hen verleende obstetrische zorg te monitoren en te bewaken. Bij het ontwikkelen van de kwaliteitsindicatoren zijn de richtlijnen van de NVOG als uitgangspunt genomen. Er is rekening gehouden met de mate waarin de indicatoren eenvoudig meetbaar en snel beschikbaar zijn en in hoeverre zij een bijdrage kunnen leveren aan verbeteringen in de zorg. De Landelijke Verloskunde Registratie (LVR) is de belangrijkste informatiebron voor de indicatoren. Na drie beoordelingsrondes door experts is een set van 35 kwaliteitsindicatoren tot stand gekomen, waarvan negentien structuur-, dertien proces- en drie uitkomstindicatoren. Structuurindicatoren hebben betrekking op de organisatie van de zorg, zoals een structurele complicatiebespreking. Voorbeelden van geselecteerde procesindicatoren zijn het percentage inleidingen en het percentage kunstverlossingen. Als uitkomstindicator is onder meer geselecteerd het percentage levendgeboren kinderen met een Apgarscore lager dan vijf, na vijf minuten.In this research project we developed a set of 35 quality indicators for obstetric care in Dutch hospitals. Selected indicators were subsequently tested in a pilot study in thirteen hospitals during six months. In general, the pilot study showed that the registration is feasible and further implementation is supported by the hospitals. The Dutch Society for Obstetrics and Gynecology (NVOG) aims to implement the set indicators in the next years. These indicators will be part of integrated quality management comprising guidelines, protocols, indicators, and quality visitation. These indicators aim to monitor the quality of care and provide physicians with information for possible quality improvement. Furthermore, some indicators may be used to support the work of the Dutch inspectorate of health care (IGZ). Starting point in the development of the indicators were the obstetric guidelines of the NVOG. Several criteria were taken into account in the selection of indicators: the indicators' relevance for the quality of obstetrical care, the potential to improve the quality of care, the validity and reliability, and the feasibility of registration. The set indicators was selected in a consensus procedure by a panel of experts. The set comprises nineteen structure, thirteen process, and three outcomes indicators. Structure indicators refer to communication, the availability of services, and the use of protocols, such as the protocol for epidural analgesia. Process indicators refer to the delivered care and treatment, for example the percentage of cesarean sections in specific subgroups. Outcome indicators refer to the health status, for example the percentage of babies with an Apgarscore less than five, five minutes after delivery. 20080609IG