An innovative implementation strategy to improve the use of Dutch guidelines on hypertensive disorders in pregnancy:A randomized controlled trial

Objective: To evaluate the effectiveness of an innovative strategy to improve implementation of evidence-based guidelines on the management of hypertension in pregnancy compared to a common strategy of professional audit and feedback. Design: Cluster randomized controlled trial (c-RCT). Setting: Sixteen Dutch hospitals. Population: All patients with a hypertensive disorder during pregnancy who were admitted to one of the participating hospitals between April 1st 2010 and May 1st 2011, were suitable for inclusion; the only exclusion criterion was the presence of lethal fetal abnormalities. Methods: Hospitals were randomly assigned to either an innovative implementation strategy including a computerized decision support system (DSS) and professional audit and feedback or a minimal implementation strategy of audit and feedback only. Main outcome measures: Primary outcome measure was a combined rate of major maternal complications. Secondary outcome measures included process-related measures on guideline adherence, and patient-related outcomes. A process evaluation was performed alongside. Results: No statistically significant difference was found in both the occurrence of major complications and most secondary outcome measures between the two groups. Process evaluation showed limited use of the computerized DSS, with a large variation between hospitals (0–49,5% of the eligible patients), but positive experiences of actual users. Conclusion: Using a computerized DSS for implementation of the clinical guidelines for the management of hypertension in pregnancy did not result in fewer major maternal and fetal complications. Limited use of the DSS in the innovative strategy group could be an explanation for the lack of effect

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

Adherence to three different strategies to prevent early onset GBS infection in newborns

Problem: Despite the introduction of preventive guidelines, no decrease in the incidence of early onset infection was observed. Background: Early onset group B streptococcal (EOGBS) infection is an important cause of neonatal morbidity and mortality. Aim: Our study was conducted to determine adherence to three guideline-based group B streptococcus (GBS) preventive strategies. Methods: A prospective experimental study clustered by obstetric collaboration region was performed between March 2013 and August 2014 among midwives, obstetricians and paediatricians in the Netherlands. At baseline, the three regions operated according to the Dutch preventive strategy (founded on the risk-based strategy) in order to prevent EOGBS infection, whereas in the study period they followed either the risk-based, the combination or the Dutch strategy. Adherence was measured prospectively per pregnant woman, using predefined core elements of each preventive strategy: identification of risk factors, maternal GBS screening, application of intrapartum antibiotic prophylaxis and observation of the child. Data about adherence to the core elements were collected from medical records, maternal questionnaires and laboratory test results. Findings: In the three regions, a total of 121 care providers and 1562 women participated. We found an overall adherence of 90% to the risk-based strategy, 57% to the combination strategy and 89% to the Dutch strategy. Adherence to a strategy in case women had EOGBS risk factors was below 20% in all strategies. Discussion: The majority of women with EOGBS risk factors did not receive the care prescribed by any of three preventive strategies and were not treated optimally. Conclusion: The risk-based and the Dutch strategy are the recommended strategies for implementation

P 23 Maternal vascular malperfusion in spontaneous preterm birth and outcome of subsequent pregnancy

INTRODUCTION Spontaneous preterm birth (SPTB) common complicates pregnancy. It has several causes and its pathophysiology has not yet been elucidated. In a significant proportion of SPTB, placental histology shows signs of maternal vascular malperfusion; these signs are commonly associated with hypertensive disorders of pregnancy (HD) or fetal growth restriction (FGR). Therefore, we hypothesized that women with a SPTB and signs of maternal vascular malperfusion in the placenta are at risk for HD and FGR in a subsequent pregnancy. OBJECTIVE The objective of this study was to describe the association between placental histology of SPTB and the incidence of HD and FGR in the subsequent pregnancy. MATERIALS AND METHODS We included women with a history of SPTB, and a subsequent ongoing pregnancy (n=110). Histological placental characteristics in the pregnancy complicated by SPTB were described according to new international guidelines, and related to the outcome of the subsequent pregnancy. RESULTS Delivery in the index pregnancy had a median gestational age of 27.7 weeks. In 61.8% (n=68) of the placentas signs of vascular malperfusion were observed. Maternal and respectively fetal inflammatory response was observed in 51.8 %(n=57) and 46.4% (n=51) and was observed as a secondary finding in 42.6% (n=29) and 36.8% (n=25) of the placentas with maternal vascular malperfusion. In the index pregnancy HD was present in 8.2% (n=9), and FGR in 10.9% (n=12). In the subsequent pregnancy HD was present in 12.7% (n=14) and FGR in 5.5 % (n=6). The incidence of HD or FGR in the subsequent pregnancy was not associated with histological signs of maternal vascular malperfusion in the index pregnancy. CONCLUSION Women with a history of SPTB have an elevated risk on hypertensive diseases in the subsequent pregnancy, when compared to epidemiologic data on the incidence of HD in women with a prior term birth. The incidence of HD was not associated with of the presence of placental maternal vascular malperfusion in the index pregnancy. This data suggest that signs of maternal vascular malperfusion by placental histology in SPTB cannot be used as a marker for adverse outcome in a subsequent pregnancy

Maternal vascular malperfusion in spontaneous preterm birth placentas related to clinical outcome of subsequent pregnancy

Introduction: Spontaneous preterm birth (SPTB) has several causes and its pathophysiology remains unclear. In a significant proportion of SPTB, placental histology shows signs of maternal vascular malperfusion (MVM); commonly associated with hypertensive disorders of pregnancy (HD), fetal growth restriction (FGR) and placental abruption, together referred to as clinical ischemic placental diseases (IPD). We hypothesized that women with SPTB and placental MVM are at elevated risk for IPD in a subsequent pregnancy. Methods: We included women with SPTB in our cohort and followed the subsequent ongoing pregnancy (n = 110). Histological placental characteristics in the index were reported according to new international guidelines, and related to the clinical outcome of the subsequent pregnancy. Results: In the SPTB placentas, we observed MVM in 61.8% (n = 68). In the subsequent pregnancies in 19.1% (n = 21) at least one clinical sign of IPD was present (HD (12.7%), FGR (5.5%) or placental abruption (0.9%)). There was no significant difference in the prevalence of clinical IPD or recurrence of SPTB in the subsequent pregnancy between women with and without placental MVM in the index pregnancy, although our study was not powered to detect small differences. Discussion: Women with a history of SPTB have an elevated risk of IPD in the subsequent pregnancy. MVM is present in a large proportion of SPTB placentas. The presence of placental MVM in the index pregnancy does not predict clinical IPD or recurrent SPTB in a subsequent pregnancy

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

markdownabstractBackground 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