Adaptation of guidelines for use at the national or local level can facilitate their implementation. We developed and evaluated an adaptation process in adherence with standards for trustworthy guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, aiming for efficiency and transparency. This article is the first in a series describing our adaptation of Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines for a Norwegian setting.
Informed by the ADAPTE framework, we developed a five-step adaptation process customized to guidelines developed using GRADE: (1) planning, (2) initial assessment of the recommendations, (3) modification, (4) publication, and (5) evaluation. We developed a taxonomy for describing how and why recommendations from the parent guideline were modified and applied a mixed-methods case study design for evaluation of the process.
We published the adapted guideline in November 2013 in a novel multilayered format. The taxonomy for adaptation facilitated transparency of the modification process for both the guideline developers and the end users. We excluded 30 and modified 131 of the 333 original recommendations according to the taxonomy and developed eight new recommendations. Unforeseen obstacles related to acquiring a licensing agreement and procuring a publisher resulted in a 9-month delay. We propose modifications of the adaptation process to overcome these obstacles in the future.
This case study demonstrates the feasibility of a novel guideline adaptation process. Replication is needed to further validate the usefulness of the process in increasing the organizational and methodologic efficiency of guideline adaptation.
To assess the prevalence and risk of adverse perinatal outcomes in early-term (37+0-38+6 weeks), full-term (39+0-40+6 weeks), late-term (41+0-41+6 weeks), and post-term (>42+0 weeks) deliveries with spontaneous labor onset.
A population-based cohort with data from the Medical Birth Registry Norway (MBRN) and Statistics Norway (SSB) was conducted. The study population consisted of 665,244 women with cephalic singleton live births at term or post-term with spontaneous labor onset during the period of 1999-2014 in Norway. Maternal, obstetric, and fetal characteristics were obtained from the MBRN. Maternal education data were obtained from the SSB. The prevalence rates of adverse perinatal outcomes for each gestational age (GA) group were estimated. Inter-group differences were detected with Chi square tests. Multivariable regression analysis adjusted for maternal age, educational level, smoking, parity, maternal diabetes, and preeclampsia was used to assess adverse outcome prevalence for early- late-, and post-term births compared to full-term births.
Deliveries at early-term were associated with an increased prevalence of neonatal jaundice, polyhydramnios, small for gestational age (SGA) status, respiratory support, and neonatal intensive care unit (NICU) admission compared with deliveries at GAs of 39-43 weeks (p
To investigate risk factors for stillbirths by cause, using the Causes of Death and Associated Conditions (CODAC) classification system for perinatal deaths.
Two university hospitals in Oslo, Norway, January 1990 through December 2003.
Women with stillbirth after 22 gestational weeks (n = 377) and controls with live births (n = 1 215), and a subsample of 105 cases and 262 controls.
Socio-demographic, clinical and thrombophilic risk factors for stillbirths were assessed by cause of death in univariate and multivariable logistic regression analyses. Stillbirths were classified according to CODAC based on information from medical records and validated placenta histology.
Causes of stillbirths in percentages, prevalence, odds ratios and adjusted odds ratios for potential risk factors.
Approximately half of the women (n = 190) had placental and 19.4% (n = 73) unknown cause of stillbirth. Placental-associated conditions were registered in 18% (n = 68) of cases with a non-placental or an unknown cause. Smoking and small-for-gestational age were more prevalent in all causal groups, compared with controls, whereas twin pregnancy, hypertension and diabetes were more prevalent only among women with placental and unknown causes of stillbirth. The F2rs179963 polymorphism and combined thrombophilia were significant risk factors for stillbirth with placental causes and antiphospholipid antibodies for stillbirth with non-placental causes.
Two-thirds of all stillbirths (68%) were caused by or associated with placental pathology. Risk factors differed somewhat according to cause, apart from smoking and small-for-gestational age, which were significant risk factors across the causal groups.
High levels of complement C3 are associated with venous thrombosis (VT) in the general population. We investigated if high C3 and C4 levels were associated with pregnancy-related VT. We undertook the Norwegian VIP study, a case-control study of VT in pregnancy or within 3 months postpartum (cases, n?=?313) and women without pregnancy-related VT (controls, n?=?353). Determinants of C3 and C4 in the control women were investigated with linear regression and the odds ratio (OR) for pregnancy-related VT was calculated with logistic regression. We found that levels of C3 and C4 were associated with body mass index (BMI), C-reactive protein (CRP); with the coagulation factors (F) fibrinogen, FVIII, and FIX; and with the coagulation inhibitors antithrombin, protein C, protein S, and tissue factor pathway inhibitor. These associations were influenced by CRP levels. The crude OR for pregnancy-related VT was 1.8 (95% confidence interval [CI], 1.1-3.0) for C3 above the 90th percentile and 2.0 (95% CI, 1.2-3.2) for C4 above the 90th percentile. Stratification in antenatal and postnatal VT showed that C3 and C4 were only associated with postnatal VT with an OR for high C3 of 3.0 (95% CI, 1.8-5.0), and for high C4 of 2.6 (95% CI, 1.5-4.6). Adjustment for high FIX and BMI reduced the ORs. We conclude that the association between postnatal VT and C3 and C4 suggests that there is clinically relevant crosstalk between the complement and the coagulation system.
To estimate incidence and risk factors for intrauterine fetal death (IUFD) in a Norwegian study-population applying two different control groups.
Two university hospitals in Oslo, Norway, January 1990 through December 2003.
The cases: 377 women with IUFD.
1) all women delivering at the study-hospitals in the period (facility-based), and 2) 1 215 women with live births at one study-hospital in the period (selected).
Information from cases and selected controls was collected from medical records. Data on facility-based controls were provided by the Medical Birth Registry of Norway. Data were analyzed using chi-squared test and logistic regression.
Incidence of IUFD and adjusted odds ratios of risk factors.
The incidence was 4.1/1 000 deliveries. Small-for-gestational age (SGA) and placental abruption were the strongest risk factors for IUFD. Hypertensive disorders were of low risk if not associated with SGA. Low to moderate risk factors were pre-pregnancy diabetes mellitus, thyroid disease, placenta previa, gestational diabetes, smoking and twin pregnancy. Advanced maternal age was significant when compared with facility-based controls. Risk estimates pointed in the same direction independent of control-group. Hypertension appeared overestimated when using facility-based controls, whereas advanced age was underestimated in the analysis among selected controls.
SGA has a strong association with IUFD, and the risk of hypertensive disorders is mediated through SGA. The other risk factors, except placental abruption, are of low prevalence and of limited importance in the prevention of a relatively low incidence, although dramatic, event like IUFD.
OBJECTIVE: To evaluate the effect and dose of dalteparin given to pregnant women with acute venous thromboembolism. DESIGN: An observational study of pregnant women in Norway. SETTING: Delivery and haematological departments in Norway. POPULATION: Twenty women, aged 22-41 years, with acute venous thromboembolism verified by objective means. METHODS: Patients were treated with dalteparin from diagnosis until delivery. Treatment was monitored with anti-activated factor Xa (anti-Xa) activity, and the dose was adjusted to achieve target 0.5-1.0 U/mL 2-3 hours post-injection. MAIN OUTCOME MEASURES: Anti-Xa activity and side effects. RESULT: None of the patients suffered recurrent venous thromboembolism or major bleeding complications. In 9 of 13 women starting with conventional dose of dalteparin (100 iu/kg bd), dose escalation was necessary to reach target anti-Xa activity. None of the six women who started with 105-118 iu/kg bd required dose escalation. One woman who started with 133 iu/kg bd required dose reduction. Bioaccumulation of dalteparin was not observed. CONCLUSION: Our study suggests that dalteparin may be used for the treatment of acute venous thromboembolism in pregnancy. Approximately 10-20% higher doses of dalteparin may be needed as compared with non-pregnant individuals.
Streptococcus agalactiae (group B Streptococcus, GBS) is the most common cause of early neonatal infection, but restricting the diagnosis to culture-positive infants may underestimate the burden of GBS disease. Our objective was to determine whether maternal GBS colonization was associated with an increased risk of transfer of term infants to the neonatal intensive care unit (NICU) and, if so, to estimate the incidence of probable early-onset GBS disease.
We conducted a prospective cohort study of 1,694 term infants whose mothers had vaginal-rectal swabs collected at delivery. Data collected on each mother and infant included demographics, clinical findings and laboratory investigations. The medical staff were unaware of the maternal GBS colonization status.
A total of 26% of the mothers were colonized. Infants born to colonized mothers did not differ from infants born to non-colonized mothers with respect to birth weight or Apgar score. Altogether, 30 (1.8%) of the term infants were transferred to the NICU. Only 1 infant born to a colonized mother had culture-positive early-onset GBS disease. Infants born to colonized mothers were more than 3 times as likely to be transferred to the NICU compared to infants of non-colonized mothers (3.6 vs. 1.1%; OR 3.4, 95% CI 1.6-6.9, p = 0.001); 5 infants of colonized mothers had probable GBS disease with tachypnoea and raised C-reactive protein (3.0/1,000 live term births).
Maternal GBS colonization is associated with increased risk of transfer to the NICU in term infants. The burden of neonatal GBS disease may be greater than indicated by the number of culture-positive cases.
Norway has low maternal mortality, but such deaths are underreported even in high-income countries. Our goal was to identify the exact number of maternal deaths, the causes of death and the potential for improvement through medical care in Norway.
We traced maternal deaths in the period from 1 January 2005 to 31 December 2009 by linking the Medical Birth Registry and the Cause of Death Registry, supplemented with data from maternity clinics. We identified the cause of death and the lessons that could be learned by a meticulous review of each case.
We found 26 maternal deaths during the period, 14 of which were due to direct causes and 12 to indirect causes. The maternal mortality ratio was 8.7/100,000 live births. Fourteen of the deaths were registered in official statistics. Of the 12 deaths that were not included in the statistics, 11 were found through matching the registers and one had been reported directly by the hospital. The most common causes of death were hypertensive disorders during pregnancy (n = 6), thromboembolism (n = 4) and mental illness (n = 4). None of the deaths due to thromboembolism appeared in official statistics. The same applied to nine of the 12 indirect maternal deaths. We found a potential for improved medical care in 14 of 26 cases. Half of these were deaths due to hypertensive disorders during pregnancy or thromboembolism.
Maternal death was considerably underreported in Norwegian official statistics during the period studied. Greater attention should be given to better blood-pressure treatment, stabilisation and timely delivery in the case of hypertension during pregnancy, and to screening for possible pulmonary embolism. The same applies to mental illness and internal medical disorders in pregnant women.
The provision of epidural analgesia during labor is ideally a shared decision between the woman and her health care provider. However, immigrant characteristics such as maternal birthplace could affect decision-making and thus access to pain relief. We aimed to assess disparities in the provision of epidural analgesia in planned vaginal birth according to maternal region of birth.
We performed a nation-wide register study of 842,496 live-born singleton deliveries in Norway between 2000 and 2015. Maternal birthplace was categorized according to the Global Burden of Disease framework. The provision of epidural analgesia was compared in regression models stratified by parity and mode of delivery.
Compared to native-born women, primiparous women from Latin America/Caribbean countries with an instrumental vaginal delivery were most likely to be provided epidural analgesia (OR 2.12, 95%CI 1.69-2.66), whilst multiparous women from Sub-Saharan Africa with a spontaneous vaginal delivery were least likely to be provided epidural analgesia (OR 0.42, 95% C 0.39-0.44). Longer residence time was associated with a higher likelihood of being provided analgesia, whereas effects of maternal education varied by Global Burden of Disease group.
Disparities in the likelihood of being provided epidural analgesia were observed by maternal birthplace. Further studies are needed to consider whether the identified disparities represent women's own preferences or if they are the result of heterogeneous access to analgesia during labor.
Venous thromboembolism (VTE) is a major cause of maternal morbidity and mortality during or early after pregnancy and in women taking hormonal therapy for contraception or for replacement therapy. Post-thrombotic syndrome, including leg oedema and leg pain, is an unrecognized burden after pregnancy-related VTE, which will affect more than two of five women. Women with a prior VTE, a family history of VTE, certain clinical risk factors and thrombophilia are at considerably increased risk both for pregnancy-related VTE and for VTE on hormonal therapy. This review critically assesses the epidemiology and risk factors for pregnancy-related VTE and current guidelines for prophylaxis and treatment. We also provide information on the risk of VTE related to hormonal contraception and replacement therapy.