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

Background: 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.Methods/Design: 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

Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term

Development and measurement of guidelines-based quality indicators of caesarean section care in the Netherlands: A RAND-modified delphi procedure and retrospective medical chart review

Background There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. Method Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. Results The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adh

SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Introduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. Methods The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals

Recurrent miscarriage and hyperhomocysteinemia

Item does not contain fulltextKUN, 14 maart 1996Promotores : Eskes, T.K.A.B., Blom, H.J., Boers, G.H.J., Hamilton, C.J.C.M., Thomas, C.M.G

[Thrombophilia and the prevention of thromboembolic complications during pregnancy and the puerperium]

Deep vein thrombosis is one of the main causes of maternal death in the Western world, pulmonary embolism, as a complication, being the immediate cause of death in most cases. Deep vein thrombosis is the end result of several, partly interrelated, inherited and acquired risk factors. Thrombophilia is the overall name for a number of specific abnormalities resulting in an increased tendency towards haemocoagulation. In order to reduce the morbidity and mortality caused by thromboembolic complications in pregnant women, all women who want to become pregnant should be screened for risk factors in order to assess the a priori risk of venous thrombosis. Based on the individual thrombosis history and the presence of thrombophilia, a prophylactic policy can be determined for every pregnant woman. Currently, there are no data available from prospective and randomised trials assessing the effects of anticoagulants in pregnant women with thrombophilia

[Thrombophilia and the prevention of thromboembolic complications during pregnancy and the puerperium]

Deep vein thrombosis is one of the main causes of maternal death in the Western world, pulmonary embolism, as a complication, being the immediate cause of death in most cases. Deep vein thrombosis is the end result of several, partly interrelated, inherited and acquired risk factors. Thrombophilia is the overall name for a number of specific abnormalities resulting in an increased tendency towards haemocoagulation. In order to reduce the morbidity and mortality caused by thromboembolic complications in pregnant women, all women who want to become pregnant should be screened for risk factors in order to assess the a priori risk of venous thrombosis. Based on the individual thrombosis history and the presence of thrombophilia, a prophylactic policy can be determined for every pregnant woman. Currently, there are no data available from prospective and randomised trials assessing the effects of anticoagulants in pregnant women with thrombophilia

Interventions for preventing gestational diabetes mellitus: a systematic review and meta-analysis

Background: The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. GDM is associated with increased risks for mother and child during pregnancy and in later life. The aim of this article is to systematically review literature on the effectiveness of interventions to prevent GDM. Methods: Controlled trials found in PubMed, EMBASE, or CENTRAL were selected. The primary outcome was GDM, and relevant secondary outcomes were maternal fasting blood glucose and large-for-gestational age (LGA) or macrosomia. Data were combined in meta-analyses, and the quality of evidence for the effectiveness of the interventions was assessed in a GRADE approach. Results: Nineteen studies evaluating six types of interventions were included. Dietary counseling significantly reduced GDM incidence compared to standard care. None of the interventions was effective in lowering maternal fasting blood glucose. Low glycemic index (LGI) diet advice and an exercise program significantly reduced the risk of macrosomia. The quality of evidence for these outcomes was low. Conclusions: The results indicate that there may be some benefits of dietary counseling, an LGI diet advice, or an exercise program. However, better-designed studies are required to generate higher quality evidence. At the moment, no strong conclusions can be drawn with regard to the best intervention for prevention of GDM. © 2011 Mary Ann Liebert, Inc