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Summary: The Danish national haemoglobinopathy screening programme seeks to determine parental haemoglobinopathy carrier state antenatally. In this retrospective register‐based study, we evaluated the 16‐year trajectory of this programme, utilising the Danish Red Blood Cell Centre's laboratory database, covering approximately 77% of the Danish population. During the study period, we observed a substantial increase in annual diagnostic examinations performed, from 389 in 2007 to 3030 in 2022. Women constituted 88% of these cases, aligning with the emphasis of the screening programme. Of these, 54% of women of reproductive age (15–40 years) and 10% of women >40 years were specified as pregnant. During our study period, 61 children were born with a severe haemoglobinopathy, out of which 23 children were born from mothers not residing in Denmark during their first trimester thus not included in the screening programme. Prenatal invasive testing was performed for 60 fetuses, identifying 12 with homozygous or compound heterozygous haemoglobinopathy. The Danish haemoglobinopathy screening programme has provided screening, information and reproductive choices for numerous families. During the study period, screening for haemoglobinopathies has been steadily increasing and is expected to continue to increase. Awareness of and adherence to the screening programme is subject of further investigation and optimisation. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14–21 weeks pregnant with persistent iron deficiency (ferritin < 30 µg/L). Methods: In a single-centre, open-label, randomised controlled trial at a Danish hospital, women with persistent iron deficiency after routine oral iron treatment were allocated to receive 1000 mg IV iron (single-dose) or 100 mg elemental oral iron daily. Outcomes were assessed during an 18-week follow-up period. The primary endpoint was the proportion of non-anaemic (haemoglobin [Hb] ≥ 11 g/dL) women throughout follow-up. Other outcomes included changes in haematological parameters, patient-reported fatigue, and quality of life (QoL). Safety was assessed by recording adverse events. Results: From July 2017 to February 2020, 100 women were randomised to IV iron and 101 to oral iron. Throughout follow-up, 91% of women were non-anaemic in the IV iron group compared with 73% in the oral iron group (18% difference [95% confidence interval 0.10–0.25]; p < 0.001). The mean Hb increase was significantly greater with IV iron versus oral iron at Weeks 6 (0.4 versus − 0.2 g/dL; p < 0.001), 12 (0.5 versus 0.1 g/dL; p < 0.001), and 18 (0.8 versus 0.5 g/dL; p = 0.01). Improvements in fatigue and QoL were greater with IV iron versus oral iron at Weeks 3 and 6. The incidence of treatment-related adverse events was comparable between treatment groups. Conclusion: IV iron was superior in preventing anaemia compared with oral iron in pregnant women with persistent iron deficiency; biochemical superiority was accompanied by improved fatigue and QoL. Clinical trial registration: European Clinical Trials Database: EudraCT no.: 2017-000776-29 (3 May 2017); ClinicalTrials.gov: NCT03188445 (13 June 2017). The trial protocol has been published: https://dx.doi.org/10.1186%2Fs13063-020-04637-z. [ABSTRACT FROM AUTHOR]

Introduction: Effects of daily iron supplementation in iron replete pregnancy are unclear. This systematic review aimed to assess benefits and harms of oral iron supplements in pregnant women without anemia and iron deficiency. Material and methods: We predefined and registered a protocol in PROSPERO (CRD42020186210) and performed the review following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) methodology. We searched for randomized clinical trials (RCTs) and observational studies comparing daily oral iron supplementation with no iron supplements in non‐anemic iron replete pregnant women. Searches were conducted in MEDLINE (by PubMed), EMBASE (by OVID), Cochrane Library, and ClinicalTrials.gov from inception to September 2022 without language restrictions. Two authors independently screened records, extracted data, and assessed risk of bias using the revised Cochrane risk of bias tool (RoB2). One author read full‐texts, assessed certainty of evidence by GRADE and conducted meta‐analyses using a random‐effects model. Primary outcomes included iron deficiency anemia, iron deficiency, hemoglobin >130 g/L, elevated iron status, small for gestational age newborns, low birthweight newborns, preterm birth, and congenital anomalies. Results: Eight RCTs (2822 women) but no observational studies were eligible for inclusion. Daily oral iron supplementation in pregnancy probably reduces iron deficiency anemia at term (risk ratio [RR]: 0.51, 95% confidence interval [CI]: 0.38–0.70; 4 RCTs, 1670 women; I2 = 13%; moderate‐certainty evidence) and the incidence of low birthweight babies (RR: 0.30, 95% CI: 0.13–0.68; 2 RCTs, 361 infants; I2 = 0%; moderate‐certainty evidence). In addition, it may reduce iron deficiency at term (RR: 0.74, 95% CI: 0.60–0.92; 4 RCTs, 1663 women; I2 = 58%; low‐certainty evidence) and the incidence of small for gestational age babies (RR: 0.39, 95% CI: 0.17–0.86; 1 RCT, 213 infants; I2 not estimable; low‐certainty evidence). Conclusions: Daily iron supplementation in iron replete non‐anemic pregnant women probably reduces the risk of maternal iron deficiency anemia at term and low birthweight. [ABSTRACT FROM AUTHOR]

Objective: The objective was to investigate the association between blood loss at delivery and physical and mental fatigue during the first 12 weeks postpartum. We also investigated the association between hemoglobin and postpartum fatigue.Methods: We performed a single center prospective longitudinal study of healthy women with a singleton delivery. Women completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale at 3 and 7 d, 3, 8 and 12 weeks postpartum. The hemoglobin level was measured at inclusion (baseline).Results: A total of 196 women with blood loss at delivery ranging from 100 to 2800 mL were included in the study. At 12 weeks follow-up the response rate was 92% (n = 181). We found a significant association between blood loss and scores of physical and mental fatigue within the first week postpartum. When adjusted for bleeding, hemoglobin measured at inclusion was not associated with fatigue at any given time point.Conclusions: The amount of measured blood loss was significantly associated with increased physical and mental fatigue in the first week postpartum. When adjusted for bleeding, baseline hemoglobin was no longer associated with physical and mental fatigue. [ABSTRACT FROM AUTHOR]

Background and objectives: To explore if intravenous iron isomaltoside (Monofer®) leads to a better relief of fatigue than current treatment practice with oral iron in women suffering from severe fatigue after postpartum hemorrhage. Materials and methods: This is a subanalysis of a single-center, open-label, randomized controlled trial conducted in women suffering from postpartum hemorrhage. Participants were randomized 1:1 to 1200 mg iron isomaltoside or current treatment practice with oral iron. We measured fatigue by the Multidimensional Fatigue Inventory (MFI) and Edinburgh Postnatal Depression Scale, and determined hematological parameters. The subanalysis includes all participants with a high fatigue score (MFI physical fatigue score >15) at inclusion. The primary endpoint was aggregated change in physical fatigue score from inclusion to 12 weeks postpartum with a predefined minimum clinically relevant difference of 1.8. The trial is registered at ClinicalTrials.gov (identifier: NCT01895218). Results: A total of 85 women had a high fatigue score at inclusion. The aggregated change in physical fatigue score was -2.3 (confidence interval 95%: -3.3; -1.3) (p < .0001) in favor of iron isomaltoside. Significant differences in other fatigue and depression scores and hematological parameters were observed and all in favor of iron isomaltoside. There were no differences in side effects between the groups. Conclusions: In women suffering from severe fatigue after postpartum hemorrhage, a single dose of iron isomaltoside is associated with a statistically significant and clinically relevant reduction in aggregated physical fatigue within 12 weeks after delivery, when compared to current treatment practice with oral iron and with a similar safety profile. [ABSTRACT FROM AUTHOR]

Background: Postpartum haemorrhage can lead to iron deficiency with and without anaemia, the clinical consequences of which include physical fatigue. Although oral iron is the standard treatment, it is often associated with gastrointestinal side effects and poor compliance. To date, no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage. The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage. Methods/Design: In a single centre, open-labelled, randomised trial, women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care. Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery. Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health (Multidimensional Fatigue Inventory, Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire), at inclusion and at follow-up visits after three days, one week, three weeks, eight weeks, and 12 weeks postpartum. The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum, as measured by a subscale of the Multidimensional Fatigue Inventory. The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue. For claiming superiority, we set the minimal clinically relevant difference between the mean scores at 1.8, and the assumed standard deviation at 4.2. Hence, 87 participants per treatment group are needed in order to demonstrate superiority; to provide an extra margin for missing data and dropouts, 200 women will be included. Discussion: The study will provide evidence on relevant clinical outcomes beyond biochemical parameters for intravenous iron isomaltoside 1000 compared to standard medical care in women after postpartum haemorrhage. Trial registration: This trial is registered with Clinicaltrials.gov (identifier: NCT01895218) on 26 June 2013. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of supplementary oxygen on heart rate and arterial oxygen saturation during colonoscopy. Design: Controlled study. Setting: Two university hospitals, Denmark. Subjects: 40 patients having colonoscopy. Interventions: 20 patients were given supplementary oxygen through nasal prongs (2 L/min), and 20 patients breathed room air during colonoscopy. All patients were given conscious sedation and were monitored with a pulse oximeter during colonoscopy. Main outcome measures: Tachycardia (pulse rate >100 min[sup -1]) and arterial oxygen desaturation (SpO[sub 2] < 90%) during colonoscopy. Results: There were no differences in the incidence of tachycardia or mean heart rate during endoscopy between the two groups, and no patient developed symptomatic cardiac arrhythmias or hypotensive episodes. 10 patients in the room air compared with none in the oxygen treatment group (p = 0.0004) had one or more episodes during which arterial oxygen saturation fell below 90% during colonoscopy, and mean oxygen saturation was higher in the oxygen treatment group than in the room air group (p < 0.001). No clinical complications occurred in either group. Conclusion: Hypoxaemia and tachycardia are common during routine colonoscopy. The use of supplemental oxygen prevented hypoxaemia, but had no significant effect on heart rate. [ABSTRACT FROM AUTHOR]

Objective: To compare the effect of occlusive (Comfeel) and conventional (Mepore) dressings on the healing of incisional wounds after abdominal operations. Design: Prospective randomised study. Setting: Laboratory and teaching hospital, Denmark. Subjects: 73 patients who underwent clean operations requiring incisions longer than 5 cm between August 1993 and August 1995 were randomised to have their wounds dressed with either Comfeel or Mepore. Interventions: Comfeel was left on until the sutures were removed, and Mepore was removed 2 days postoperatively. Main outcome measures: Infection, adherence, leakage, and cosmetic appearance three months later. Results: 36 patients were randomised to have Comfeel and 37 to have Mepore. 29 patients were withdrawn from the study (20 having Mepore and 9 having Comfeel) leaving 26, and 17 for analysis, respectively. Wound infections developed in 1 patient in the Comfeel group and 5 in the Mepores group (p = 0.2). There were no differences between the groups regarding the need for dressings to be changed, the incidence of leakage, or loosening of the dressing from the skin. Comfeel adhered securely to the skin and remained more or less transparent until sutures were removed. It remained totally transparent in 23 (64%), and no dressing became totally opaque. There were no differences in cosmetic appearance after three months. We had the impression that patients who had Comfeel were more comfortable and found it easier to mobilise and carry out their daily activities. Conclusion: Occlusive dressings stay in place and stay transparent, and do not increase the risk of wound infection. They may even be more comfortable. they are a reasonable alternative to conventional dressings. [ABSTRACT FROM AUTHOR]

Due to the necessity of iron for a variety of cellular functions, the developing mammalian organism is vulnerable to iron deficiency, hence causing structural abnormalities and physiological malfunctioning in organs, which are particularly dependent on adequate iron stores, such as the brain. In early embryonic life, iron is already needed for proper development of the brain with the proliferation, migration, and differentiation of neuro-progenitor cells. This is underpinned by the widespread expression of transferrin receptors in the developing brain, which, in later life, is restricted to cells of the blood–brain and blood–cerebrospinal fluid barriers and neuronal cells, hence ensuring a sustained iron supply to the brain, even in the fully developed brain. In embryonic human life, iron deficiency is thought to result in a lower brain weight, with the impaired formation of myelin. Studies of fully developed infants that have experienced iron deficiency during development reveal the chronic and irreversible impairment of cognitive, memory, and motor skills, indicating widespread effects on the human brain. This review highlights the major findings of recent decades on the effects of gestational and lactational iron deficiency on the developing human brain. The findings are correlated to findings of experimental animals ranging from rodents to domestic pigs and non-human primates. The results point towards significant effects of iron deficiency on the developing brain. Evidence would be stronger with more studies addressing the human brain in real-time and the development of blood biomarkers of cerebral disturbance in iron deficiency. Cerebral iron deficiency is expected to be curable with iron substitution therapy, as the brain, privileged by the cerebral vascular transferrin receptor expression, is expected to facilitate iron extraction from the circulation and enable transport further into the brain. [ABSTRACT FROM AUTHOR]

Iron deficiency and anaemia in the puerperium are associated with several important clinical consequences, most prominently physical fatigue. Current treatment practice with oral iron supplementation is associated with gastrointestinal side-effects and subsequent poor compliance. Red blood cell transfusion is also widely used to treat severe postpartum anaemia, though accumulating evidence questions its risk-benefit ratio. Intravenous iron has in previous studies been associated with fast improvement of haemoglobin and iron biochemical markers in the treatment of postpartum anaemia, but there is a lack of studies on patient reported outcomes.
 The thesis is based on three studies of intravenous iron (Monofer, iron isomaltoside) as an alternative to current treatment practice in postpartum iron deficiency and anaemia.
The first study is a randomised controlled trial comparing a high single-dose iron infusion with oral iron in women after postpartum haemorrhage without severe anaemia. The primary outcome was the aggregated change in physical fatigue within 12 weeks postpartum. We found a difference that was statistically significant, but less than the consensus-based and predefined minimal clinically relevant level. Across visits, particularly in the first weeks postpartum, we found statistically significant differences in fatigue and depression scores, all in favour of intravenous iron. We confirmed previous findings of a fast haematopoietic response and prompt replenishment of iron stores that persisted throughout the 12 weeks of follow-up. 
The second study, a randomised controlled pilot study, tested feasibility and exploratory outcomes of a high single-dose iron infusion compared with red blood cell transfusion for the treatment of severe postpartum anaemia. We found that randomisation could be feasible with some adjustments for a future study design. The difference in biochemical markers was larger than the patient-reported outcomes in the first week. A larger trial is needed to determine whether a high single-dose iron infusion is non-inferior to red blood cell transfusion in severe postpartum anaemia. 
The third study compared iron concentration in breast milk in a randomised sample of women receiving high single-dose iron infusion or oral iron. A high single-dose iron infusion lead to a transient increase in the iron concentration in breast milk, which remained within the normal range. 
In conclusion, iron isomaltoside seems to be associated with improved patient-reported outcomes compared to oral iron treatment, and in severe postpartum anaemia intravenous iron seems promising as an alternative to red blood cell transfusion.

Background: Computer imaging enables a surgeon to simulate the postoperative result in a quite artistic and natural manner. Many plastic surgeons, however, are reluctant to use this sophisticated new tool for various reasons, such as the cost of the equipment, the learning process, the extra time involved, and the potential medicolegal implications. The aim of this study was to add experience to the value of computer imaging for rhinoplasty., Methods: One hundred twenty patients with corrective rhinoplasty were followed from 1 to 5 years postoperatively. The authors and the patients compared the "virtual" with the surgical results on a scale from 1 to 4, where 1 = identical, 2 = similar, 3 = approximate, and 4 = poor., Results: Approximately 70 percent of the surgical results were rated identical or similar by the authors versus 80 percent by the patients, 25 percent versus 14 percent were rated approximate, and only 5 percent versus 2.5 percent were rated as poor. The outcome of the matches between the simulation and the postoperative results correlates favorably with the authors' experiences during the precomputer era. The patients who were satisfied with the outcome in general were not critical about the accuracy of the match. So far, the authors have not experienced medicolegal problems., Conclusions: The authors have been using computer imaging for more than 5 years, with growing enthusiasm; it has become a valuable tool with which to communicate potential results to the patient during consultation and planning of the procedure. The extra time necessary is well invested. The available software programs are affordable and easy to handle, even for nonexperts.

Thermal noise, including hypothermia and short-term variations in body temperature, has been reported to influence the accuracy and reproducibility of thermodilution measurements. This variation might theoretically limit the usefulness of this technique in patients with acute burns. We therefore sought to determine the reproducibility of hemodynamic parameters derived from arterial thermal dilution in patients with acute burns and hypothermia. This was a prospective, clinical study of 50 mechanically ventilated patients with burns involving more than 25% of the body surface area that were treated at an eight-bed intensive care burn unit in a university-affiliated hospital. A total of 750 arterial thermodilution measurements were analyzed using the COLD system. Triplicate measurements of the intrathoracic blood volume, cardiac output, total blood volume, and extravascular lung water were performed at regular intervals during the first 48 hours after the thermal injury. Reproducibility was assessed by the coefficient of variation of the triplicate measurements. The correlation of variation was less than 10% at all measurement times for cardiac output, intrathoracic blood volume, and total blood volume. For the extravascular lung water, the coefficient of variation ranged from 9.5% to 12.9%. A maximum of 12.9% was found at 48 hours after burn. No correlation was found between body core temperature and the reproducibility of intrathoracic blood volume index (r = 0.145), cardiac index (r = 0.217), or extravascular lung water index (r = 0.167). The parameters derived from arterial thermodilution show a clinically sufficient reproducibility in patients with acute burns associated with thermal instability.

Abdominoplasty procedures involve a high risk of early complications, including hematomas, seromas, necrosis, and wound-healing problems. Their rationale is evident from the vascular anatomy of the abdominal wall, as traditional abdominoplasty includes a division of the main perforating vessels. No studies exist to quantitatively assess the consequences of abdominoplasty on the perfusion of the random pattern abdominal flap. To address this issue and quantify the influence of classic abdominoplasty on the perfusion of the abdominal skin, the authors performed a prospective clinical trial including 15 low-risk patients undergoing abdominoplasty for aesthetic purposes. Perfusion of the abdominal flap was measured intraoperatively using the technique of dynamic laser-fluorescence-videoangiography. In the region between the umbilicus and the transverse scar (zone 1), the increment of fluorescence (the slope of the intensity curve during inflow of the indocyanine green) was recorded and compared with the intensity curve of normal tissue that was not involved in surgery (thoracic wall). The results of the intraoperative indocyanine green perfusography showed a significant impairment of the vascular supply of zone 1 in all patients. The mean perfusion index in this region was 17.2 percent (range, 5 to 32 percent) of the perfusion of the surrounding skin that was not involved in surgery. The complication rate was 33 percent (five patients) and included two cases of hematoma and three cases of scar dehiscence with skin and/or fat necrosis. These data indicate that conventional abdominoplasty including extended undermining and division of the superficial and the deep arterial systems causes profound devascularization of the abdominal flap. This might explain the high incidence of complications following this procedure.