Home management by remote self-monitoring in intermediate- and high-risk pregnancies: A retrospective study of 400 consecutive women.

INTRODUCTION: Home management in general is considered to improve patient well-being, patient involvement and cost-effectiveness, for obstetric patients as well. But concerns regarding inclusion of intermediate- and high-risk pregnant women are an issue and a limitation for clinical implementation. This retrospective study evaluated the outcome and safety of extended remote self-monitoring of maternal and fetal health in intermediate- and high-risk pregnancies. MATERIAL AND METHODS: The study reports on 400 singleton pregnancies complicated by preterm premature rupture of membranes (PPROM), fetal growth restriction, preeclampsia, gestational diabetes mellitus, high-risk of preeclampsia, or a history of previous fetal or neonatal loss. Remote self-monitoring was performed by pregnant women and included C-reactive protein, non-stress test by cardiotocography, temperature, blood pressure, heart rate, and a questionnaire concerning maternal and fetal wellbeing. Data were transferred to the hospital using a mobile device platform and evaluated by healthcare professionals. In case of non-reassuring registrations, the pregnant women were invited for assessment at the hospital. Primary outcome was perinatal death. Secondary outcomes were other maternal and perinatal complications. RESULTS: No severe maternal complications were observed. Nine fetal or neonatal deaths occurred, all secondary to malformations, severe fetal growth restriction, extreme prematurity or lung hypoplasia in cases of PPROM before 24 weeks. Even in the latter group, fetal and neonatal survival was 78% (18/23) and rose to 97% (60/62) when PPROM occurred after a gestational age 23+6 weeks. None of the fetal or neonatal deaths were attributable to the home-management setting. CONCLUSIONS: Home-monitoring including remote self-monitoring of fetal and maternal well-being in intermediate- and high-risk pregnancies seems to be a safe alternative to inpatient or frequent outpatient care, which sets the stage for a new way of thinking of hospital care. The implementation process included staff training workshops and development of patient enrollment practice with clarification of expectations and responsibilities, which can be crucial to the results.

Ready for the Triple Aim? Perspectives on organizational readiness for implementing change from a Danish obstetrics and gynecology department.

BACKGROUND: As health care strives towards the Triple Aim of improved population health, patient experience, and reduced costs, an organization's readiness for change may be a key factor. The concept refers to the collective commitment of organizational members to a change and belief in their shared ability to make that change happen (efficacy). This study aims to assess the organizational readiness for implementing large-scale change at a clinical department in pursuit of the Triple Aim and to determine key associated factors. METHODS: A cross-sectional study at a Danish Obstetrics and Gynecology department faced with external pressure to become more efficient without compromising patient outcomes and experience. The Organisational Readiness for Implementing Change (ORIC) questionnaire was distributed to all employees (n = 403). Descriptive statistics was used to assess overall organizational readiness and single items. The between-group differences in subject characteristics were assessed with independent t-test and non-parametric test. Multiple linear regression was employed to control for potential confounders. RESULTS: Response rate was 72%. The level of agreement with the commitment statements was high, and low with the efficacy statements. We did not observe statistically significant differences in the overall score between organizational sections or in relation to gender, age, or profession. Managerial status (B = 3.2, 95% CI = .52, 5.9, P = .02) or interim employment(B = 2.7, 95% CI = .47, 4.9, P = .02) were significant predictors of a high change efficacy score after controlling for potential confounders. CONCLUSIONS: Changes related to pursuit of the Triple Aim were seen as something that "has to" be done, but left managers, and even more so staff, wondering what "to do" and "how to" do it. Change strategies should therefore address these uncertainties by translating political "have to's" proposals that resonate with staff, spark engagement, and clarify "how to" deal with the complexity of large-scale change.

[Pregnancy predispose to higher incidence of venous thromboembolism]. / Graviditet medfører øget risiko forvenøs tromboemboli.

Venous thromboembolism (VTE) is a major cause of maternal morbidity and mortality despite the possibility to prevent and treat the disorder. The hypercoagulability of normal pregnancy predispose to an approximately six-fold higher incidence of VTE in pregnancy. Identification of risk pregnancies and start of prophylaxis is essential, as is early diagnosis of VTE to prevent progression and pulmonary embolism. For anticoagulant treatment and prophylaxis in pregnancy, low molecular weight heparin is the drug of choice and prophylaxis, if indicated, should initiate as soon as pregnancy is confirmed.

Evidence regarding an effect of marine n-3 fatty acids on preterm birth: a systematic review and meta-analysis.

BACKGROUND: Preterm delivery remains a substantial healthcare problem, complicating 5-10% of pregnancies, and is the major cause of perinatal morbidity and mortality in the developed world. Few effective methods to prevent preterm delivery have been identified to date. OBJECTIVE: To review systematically the evidence from randomized controlled trials with respect to the hypothesis that increased consumption of marine n-3 fatty acids in pregnancy can prevent preterm birth. SETTING: Electronic searches of the following databases were performed: PubMed (1995-2009), SCOPUS including EMBASE (1995-2009), and Cochrane Library. A combination of key words and text words related to fish oil, marine n-3 fatty acids, fish consumption, preterm birth, preterm delivery, prematurity, pregnancy duration, gestational age, parturition, delivery and pregnancy were used. METHODS: A systematic review of randomized controlled trials of relevance was conducted. Three trials were included, comprising 921 women for whom data on gestational age and 1 187 women for whom data on birthweight were available. RESULTS: Overall, 46 (8.9%) of 516 women who received n-3 fatty acids gave birth before 37 completed weeks of gestation, compared with 66 (16.3%) of 405 in the control group [relative risk 0.61; 95% confidence interval (CI) 0.40-0.93; p<0.05]. Data on delivery before 34 completed weeks showed the same trend (relative risk 0.32; 95% CI 0.09-0.95). Overall, the mean birthweight was 71g higher in women who received n-3 fatty acids during pregnancy (95% CI 4.73-138.12; p<0.05). The rate of low birthweight was not statistically significantly different between the intervention and the control groups. The mean gestational age at delivery was significantly higher by 4.5 days in the intervention group supplemented with n-3 fatty acids compared with placebo (95% CI 2.3-6.8; p<0.05). CONCLUSIONS: Marine n-3 fatty acids administered in pregnancy reduce the rate of preterm birth and increase birthweight.

Changes in fibrin D-dimer, fibrinogen, and protein S during pregnancy.

BACKGROUND: Pregnancy is a hypercoagulable state with a 5- to 10- fold higher risk of venous thromboembolism. Existing reference intervals for fibrin D-dimer (D-dimer), functional fibrinogen (fibrinogen) and protein S, free antigen (protein S) are based on non-pregnant patients and reference intervals for pregnant patients are warranted. Objectives. The aim of the present study was to contribute to the establishment of reference intervals for D-dimer, fibrinogen and protein S during pregnancy and to discuss the use of the analyses during pregnancy. METHODS: We included 55 healthy pregnant women in gestational week 11-17, with normal current pregnancy. Blood samples were collected in gestational weeks 11-17, 21-27 and 34-37. The three plasma parameters D-dimer, fibrinogen and protein S were analysed by STA-R Evolution®. RESULTS: A significant rise in D-dimer was found from first to second trimester (p < 0.0001) and from second to third trimester (p < 0.0001). The level of fibrinogen rose significantly from second to third trimester (p < 0.0001). Protein S showed a statistically significant fall in the level from first to second trimester (p < 0.0001) and remained stable thereafter. CONCLUSION: Changes during pregnancy in plasma D-dimer, protein S and fibrinogen were confirmed. Further clinical studies are needed to clarify a clinical useful cut-off point for D-dimer in pregnancy. We suggest careful attention to a low peripartum fibrinogen, since it indicates an increased bleeding risk. We confirmed an earlier suggested lower cut-off point for protein S, during pregnancy.

Thrombophilia risk factors are associated with intrauterine foetal death and pregnancy-related venous thromboembolism.

Pregnancy in healthy women is accompanied by hypercoagulable changes that may interact with thrombophilia risk factors and threaten pregnancy. However, the literature on this issue is conflicting. In investigating the relationship between pregnancy-associated complications and the presence of thrombophilia risk factors, we studied the records of 414 women who had been examined for inherited and acquired thrombophilia in the period 1996 to 2006 because of pregnancy-associated complications. Of a total of 885 pregnancies among the women, 397 were recorded as foetal loss/intrauterine foetal death during the first (62 %), second (25 %) or third trimester (13 %). One-hundred-and-two (25 %) women had had a thromboembolic event during one of their pregnancies, and 98 (24 %) had had pre-eclampsia on at least one occasion. Intrauterine growth restriction was found in 105 (25 %) of the women, and 29 (7 %) suffered placental abruption. We found that 120 (29 %) women had at least one thrombophilia risk factor. Factor V Leiden heterozygosity was the most common thrombophilia factor (n = 52), mostly linked with the risk of venous thromboembolism during pregnancy or postpartum and to foetal death during the second or third trimester. Fifty-three (13 %) women had antiphospholipid antibodies (lupus anticoagulant and/or anti-beta2-glycoprotein 1 antibodies) mainly associated with the risk of spontaneous abortion during the first trimester. In conclusion, thrombophilia was found to be considerably more common in women with pregnancy-associated complications in comparison with the general population, and most frequently in conjunction with venous thromboembolism during pregnancy and the postpartum period.

Fish oil intake compared with olive oil intake in late pregnancy and asthma in the offspring: 16 y of registry-based follow-up from a randomized controlled trial.

BACKGROUND: Evidence suggests that asthma is rooted in the intrauterine environment and that intake of marine n-3 polyunsaturated fatty acids (n-3 PUFAs) in pregnancy may have immunomodulatory effects on the child. OBJECTIVE: Our aim was to examine whether increasing maternal intake of n-3 PUFAs in pregnancy may affect offspring risk of asthma. DESIGN: In 1990, a population-based sample of 533 women with normal pregnancies were randomly assigned 2:1:1 to receive four 1-g gelatin capsules/d with fish oil providing 2.7 g n-3 PUFAs (n = 266); four 1-g, similar-looking capsules/d with olive oil (n = 136); or no oil capsules (n = 131). Women were recruited and randomly assigned around gestation week 30 and asked to take capsules until delivery. Among 531 live-born children, 528 were identified in registries and 523 were still alive by August 2006. Diagnoses from the International Coding of Diseases version 10 were extracted from a mandatory registry that recorded diagnoses reported from hospital contacts. RESULTS: During the 16 y that passed since childbirth, 19 children from the fish oil and olive oil groups had received an asthma-related diagnosis; 10 had received the diagnosis allergic asthma. The hazard rate of asthma was reduced by 63% (95% CI: 8%, 85%; P = 0.03), whereas the hazard rate of allergic asthma was reduced by 87% (95% CI: 40%, 97%; P = 0.01) in the fish oil compared with the olive oil group. CONCLUSION: Under the assumption that intake of olive oil in the dose provided here was inert, our results support that increasing n-3 PUFAs in late pregnancy may carry an important prophylactic potential in relation to offspring asthma.

Duration of pregnancy in relation to seafood intake during early and mid pregnancy: prospective cohort.

We examined the association between exposure to seafood intake during two periods of pregnancy on the one hand and risks of preterm delivery and postterm delivery on the other. In a prospective cohort of 8729 pregnant Danish women, we assessed frequency of fish meals during the first and second trimester of pregnancy by questionnaires completed around gestation weeks 16 and 30, respectively. When fish intake was based solely on intake reported for the early period of pregnancy, mean gestation length was shorter by 3.91 (95% CI: 2.24-5.58) days and odds of preterm delivery were increased 2.38 (1.23-4.61) times in those who never consumed fish (n = 308) vs. those who consumed both fish as main meal and fish in sandwiches at least once per week (n = 785). These measures were similar when fish intake was based solely on intake reported for mid-pregnancy. In the subgroup of women reporting same intake in the two trimesters, those who never consumed fish (n = 165) had 8.57 (5.46-11.7) days shorter mean gestation and 19.6 (2.32-165) times increased odds of preterm delivery, compared to high fish consumers (n = 127); odds of elective and postterm delivery were reduced by a factor 0.33 (0.11-1.02) and 0.34 (0.12-0.95), respectively, in zero fish consumers. All analyses were adjusted for potential confounding by factors such as maternal smoking, height, and prepregnant weight. We conclude that never consuming fish in the first two trimesters of pregnancy was an extremely strong risk factor for preterm delivery but was also associated with reduced risks of elective delivery and postterm delivery.

A randomized controlled trial of the effect of fish oil supplementation in late pregnancy and early lactation on the n-3 fatty acid content in human breast milk.

The aim of this research was to investigate the effect of fish oil supplementation, in the third trimester of pregnancy and early lactation period of healthy pregnant Danish women. Forty-four pregnant women were randomly allocated to fish oil supplementation (1.3 g EPA and 0.9 g DHA per day) from week 30 of gestation (FO-group) or to a control regimen (olive oil or no oil; controls). The FO-group was randomly subdivided into women stopping fish oil supplementation at delivery IFO(pregn)], and women continuing supplementation for an additional 30 d [FO(pregn/lact)]. Thirty-six women agreed to collect milk samples at days 4, 16, and 30 postpartum. The FA composition of the milk samples was determined by GLC. At days 4, 16, and 30 in lactation, FO(pregn/lact) women (n = 12) had, respectively 2.3 (P = 0.001), 4.1 (P = 0.001), and 3.3 (P = 0.001) times higher mean contents of LCPUFA(n-3) in their breast milk compared with controls (n = 13), and 1.7 (P = 0.005), 2.8 (P = 0.001), and 2.8 (P = 0.001) times higher LCPUFA(n-3) contents, respectively, at these days compared with FO(pregn) women (n = 11). The latter group did not differ significantly from controls with regard to LCPUFA(n-3) content in the breast milk. Similar results were obtained when analyzing separately for effects on the milk content of DHA. Dietary supplementation with 2.7 g LCPUFA(n-3) per day from week 30 of gestation and onward more than tripled the LCPUFA(n-3) content in early breast milk; supplementation limited to pregnancy only was much less effective.