Reorganising and improving quality of care for hyperemesis gravidarum in a Danish hospital: a quality improvement project.

BACKGROUND: Hyperemesis gravidarum (HG) is a pregnancy complication comprising severe nausea and vomiting in pregnancy. It is associated with adverse outcomes for both mother and child. Treatment consists primarily of antiemetics and intravenous fluids; however, support from healthcare professionals is also important. LOCAL PROBLEM: At the department of obstetrics at Nordsjællands Hospital, an increasing workload caused challenges regarding patient care and organisation for patients with HG, and exploring possibilities of reorganising HG care to release midwife resources was warranted. METHODS: Through input from staff and patients, possible improvements were identified. Plan-do-study-act cycles were conducted with staff and patients, resulting in adjustments in care and organisation and thus use of resources. The specific, measurable, attainable, realistic and timely aims included patient satisfaction and number of follow-ups conducted via phone. INTERVENTIONS: HG care was relocated to the department of gynaecology, where it was managed primarily by nurses. Staff and patients were actively involved in the process. RESULTS: HG care was successfully relocated without compromising patient satisfaction. Additionally, an option of patient-administered home treatment for selected patients was established. CONCLUSION: This quality improvement project describes the relocation and set-up of hospital care provided to patients with HG, resulting in high patient satisfaction. This project might serve as an inspiration to other departments of obstetrics and gynaecology.

Hydrops fetalis.

Congenital hydrops fetalis describes an abnormal accumulation of fluid in two or more compartments in a fetus. The disease is categorized based on the aetiology: immune- and non-immune hydrops fetalis. Today, the non-immune form is the most common. Once born, the child is initially handled symptomatically and will often need intensive care and treatment. Even though approximately one in five cases is still idiopathic, genetic diagnostic tools have become increasingly important in the diagnostic process. The prognosis depends on the aetiology and the gestational age when diagnosed and at birth, as argued in this review.

Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study.

OBJECTIVE: To investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes. METHODS: A register-based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine-exposed pregnancies were compared with mirtazapine unexposed pregnancies in a 1:4 ratio matched according to propensity scores. Outcomes were major congenital malformations analyzed using log binomial models, and spontaneous abortion, stillbirth and neonatal death analyzed using Cox proportional hazard regression. RESULTS: From a source population of 1,650,649 pregnancies, the propensity score-matched cohort included 4475 pregnancies (895 mirtazapine exposed) in the analysis of major congenital malformations. The analyses of spontaneous abortion included 9 500 pregnancies (1900 mirtazapine exposed), and for the analyses of stillbirths and neonatal deaths 9725 (1 945 mirtazapine-exposed) and 4485 pregnancies (897 mirtazapine-exposed) were included, respectively. Thirty-one (3.5%) children were diagnosed with major congenital malformation among the mirtazapine exposed compared with 152 (4.3%) among the unexposed pregnancies (OR=0.81, 95% CI 0.55-1.20). Spontaneous abortion occurred in 237 (12.5%) of the mirtazapine exposed compared with 931 (12.3%) of the unexposed pregnancies (HR = 1.04%, 95% CI 0.91-1.20). The analyses revealed no increased risk of stillbirth (HR = 0.88%, 95% CI 0.34-2.29) or neonatal death (HR = 0.60%, 95% CI 0.18-2.02). CONCLUSIONS: In this nationwide Danish register study, mirtazapine exposure in pregnancy was not associated with major congenital malformations, spontaneous abortion, stillbirth, or neonatal death. Clinicians and patients can be reassured that mirtazapine is safe in pregnancy.

Reduction in maternal mortality in Denmark over three decades.

INTRODUCTION: Women very rarely die during pregnancy and childbirth in Denmark. Although maternal deaths are registered worldwide, various studies indicate that underreporting does occur. This paper presents validated Danish register data for two periods between 1985 and 2017. METHODS: Maternal deaths were identified from 1985 to 1994 and from 2002 to 2017 by linking four national health registers, death certificates and notifications from maternity wards. A group of obstetricians categorised and assessed all medical records, classifying each case by cause of death. RESULTS: Linkage of four registers yielded valid data, leading to the identification of 143 maternal deaths in the abovementioned periods. From 1985-1994 there were 73 deaths and 618,021 live births, resulting in a maternal mortality rate of 11.8 per 100,000 live births with a non-significant 2% annual increase (95% confidence interval (CI): -6.0-11.0%). From 2002 to 2017 there were 70 maternal deaths and 999,206 live births, resulting in a maternal mortality rate of 7.0 per 100,000 live births (95% CI: 5.5-8.9) with a significant 9% annual decrease (95% CI: 4.0-14.0%). CONCLUSIONS: Overall maternal mortality decreased in the course of the two periods (n = 33 years), with a significant decrease during the last period. This is suggested to be a result of multiple clinical and organisational improvements as discussed in the paper. FUNDING: none. TRIAL REGISTRATION: not relevant.

Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial.

INTRODUCTION: Current pharmacological treatment options for hyperemesis gravidarum have been introduced based on scarce evidence and are often not sufficiently effective. Several case reports suggest that mirtazapine, an antidepressant, may be an effective treatment for hyperemesis gravidarum, but so far there are no controlled trials investigating the potential effect of mirtazapine on hyperemesis gravidarum. The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women. This study aims to investigate the effect of mirtazapine on hyperemesis gravidarum while also providing data on the effect of ondansetron. METHODS AND ANALYSIS: This randomised double-blind placebo-controlled multicentre trial will be conducted in eight Danish hospitals. One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum will be randomly allocated to 14-day treatment with either mirtazapine, ondansetron or placebo. Main inclusion criterion will be Pregnancy Unique Quantification of Emesis (PUQE-24) score ≥13 or PUQE-24 score ≥7 if accompanied by weight loss >5% of pre-pregnancy weight or hospitalisation. Participants are eligible regardless of whether other antiemetics, including ondansetron, have been tried. The coprimary outcomes are effects of mirtazapine and ondansetron, respectively, on PUQE-24 score tested hierarchically on day 2 and day 14. Secondary outcomes include, but are not limited to, differences between the three groups in number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects. ETHICS AND DISSEMINATION: The trial has been approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. Results will be published in peer-reviewed journals and submitted to relevant conferences. TRIAL REGISTRATION NUMBER: NCT03785691.

A new model of paired clinical teaching of international and Danish medical students.

INTRODUCTION: Since 2006, one hospital has offered two clinical courses in obstetrics/gynaecology and paediatrics to international (I) students. However, as I-student enrolment increased, the hospital faced cut-backs. As from 2010, I-team course evaluations therefore dropped to unacceptable levels and more I- than Danish (DK) students failed exams. Therefore, in 2012 we started a three-year internationalisation project (I-project) at two hospitals. The primary intervention was to pair training for I- and DK-students at clinical contact, and to offer an exclusive daily lecturer for I-teams. METHODS: We compared the course evaluations and exam grades of I-teams and DK-teams for two years prior to (107 from I-teams - 211 participants from DK-teams) and during the I-project (245 participants from I-teams - 575 from DK-teams). RESULTS: During the I-project, the I-teams' course evaluations increased to acceptable values and to levels comparable to the evaluation scores of DK-teams. Furthermore, I-students now considered that their communication with the patients was acceptable. Before the I-project, I-students had lower exam grades (median = 10 (range: 0-12)) than DK-students (10 (4-12)) (p = 0.03), but during the I-project, exam grades increased to the levels achieved by DK-students (10 (2-12) - 10 (0-12) (p = 0.22), and no more I- than DK-students failed exams (p = 0.51). CONCLUSIONS: Pairing students for clinical training and allocating an exclusive lecturer for I-teams produced improved courses for internationalisation. Allocating an exclusive lecturer was associated with a cost of about 615 EUR per student per course when the team consisted of ten students. FUNDING: The Capital Region of Denmark and the University of Copenhagen. TRIAL REGISTRATION: not relevant.

Maternal mortality in Denmark, 1985-1994.

OBJECTIVES: In Denmark, maternal mortality has been reported over the last century, both locally through hospital reports and in national registries. The purpose of this study was to analyze data from national medical registries of pregnancy-related deaths in Denmark 1985-1994 and to classify them according to the UK Confidential Enquiry into Maternal Deaths (CEMD). STUDY DESIGN: All deaths of women with a registered pregnancy within 12 months prior to the death were identified by comparing the Danish medical registries, death certificates, and relevant codes according to International Classification of Diseases (ICD-10). All cases were classified using the UK CEMD classification. Cases of maternal death were further evaluated by an audit group. RESULTS: 311 cases were classified. 92 deaths (29.6%) occurred 42 days), 1 woman died from a direct obstetric cause, 46 from indirect causes, and 172 from fortuitous causes. Hypertensive disorders of pregnancy were the major cause of direct maternal deaths. The rate of maternal deaths constituted 9.8/100,000 maternities (i.e. the number of women delivering registrable live births at any gestation or stillbirths at 24 weeks of gestation or later). CONCLUSION: This is the first systematic report on deaths in Denmark based on data from national registries. The maternal mortality rate in Denmark is comparable to the rates in other developed countries. Fortunately, statistics are low, but each case represents potential learning. Obstetric care has changed and classification methods differ between countries. Prospective registration and registry linkage seem to be a way to ensure completion. This retrospective study has provided the background for a prospective study on registration and evaluation of maternal mortality in Denmark.

Illustrative estimates of costs and effects of the use of Doppler ultrasonography in high-risk pregnancies.

OBJECTIVES: To examine the cost-effectiveness of Doppler ultrasonography in high-risk pregnancies. METHODS: An analysis was made of the cost-effectiveness of Doppler ultrasonography in high-risk pregnancies in relation to different organizational models. National costs of Doppler ultrasonography for singleton pregnancies with intrauterine growth retardation were estimated for three models. The cost-effectiveness analysis was based on results from a meta-analysis on clinical effects, patient costs, immediate health care costs, and costs per "saved" perinatal death. RESULTS: In the decentralized model (the current situation in Denmark), incremental health care costs were estimated to be 13.5 million DKK, with patient costs set at zero. In the regional and centralized models, the estimated costs were 9.3 million/0.9 million DKK and 3.4 million/2.6 million DKK, respectively. The incremental costs were more than outweighed by the savings made from significant reductions in obstetric interventions. The centralized model dominated the other two models in the cost-effective analysis. In the decentralized model, the costs of avoiding one perinatal death were estimated to be 1 million DKK. The sensitivity analysis suggested that the cost-effectiveness ratio differed considerably, depending on the assumptions used, although the rank order of the three models did not change. CONCLUSIONS: The cost-effectiveness analysis showed that a centralized model with five obstetric centers offering Doppler ultrasonography dominates the regional and decentralized models. However, even with the decentralized model (which reflects the current situation in Denmark), the costs of avoiding one perinatal death would seem to be reasonable. In view of the paucity of available cost and effects data and the sensitivity of the results to changes in the assumptions made, more reliable information is needed before a decision can be made regarding the organization of Doppler ultrasonography for high-risk pregnancies.

Doppler ultrasonography in singleton pregnancies at risk of intrauterine growth retardation-- a national estimate.

BACKGROUND: In order to assess the organizational and economical implications of Doppler ultrasonography used in high risk pregnancies, a national estimate of the use in singleton pregnancies with risk of small for gestational age (>2 SD below mean birthweight) (SGA) or intrauterine growth retardation (IUGR) was needed. METHODS: Through retrospective analyzes of both national registry data, and local clinical and ultrasonic records from Copenhagen University Hospital annual populations of singleton pregnant women with suspected IUGR and/or infants born SGA were described. The antenatal care program for assessing pregnancies with suspected IUGR was described. RESULTS: In 1996 2.8% of all singleton infants were born SGA. The population had increased risk of perinatal mortality and morbidity, and about 40% had labor induced or were delivered by caesarean section, compared to 15% of the infants with normal birthweight. In the local population 79 (3.3%) of singleton infants were born SGA and 2/3 of these were considered SGA or IUGR before delivery. Of all singleton pregnancies, a total of 88 (3.7%) were assessed by ultrasonic fetometry because of a risk or clinical suspicion of SGA, and 49 (55.7%) of these pregnancies resulted in a SGA infants. Combining national and local data it is estimated that in Denmark, about 2000 women (3.1%) will be referred for ultrasonic fetometry each year because of a risk or clinical suspicion of SGA and have a mean of 2.5 fetometries. About 75% (1500) will be further assessed by Doppler ultrasonography and have a mean of 3.4 Doppler examinations. CONCLUSION: The annual number of Doppler ultrasonography examinations in singleton pregnancies with increased risk of or signs of IUGR is estimated to be about 5000.