The extended gentle caesarean section protocol-expanding the scope and adding value for the family: a cross-sectional study.

PURPOSE: In Switzerland, about one in three children is born by caesarean section (CS). For many women, this means a restricted birth experience, limited observation of the birth process and a restricted involvement. We evaluated an extended gentle CS protocol, which offered early intraoperative skin-to-skin contact and the possibility of observing the delivery of the baby from the abdomen through a transparent drape. METHODS: This is a cross-sectional study incorporating data from a purposely tailored questionnaire and clinical routine data. The extended gentle CS protocol was compared with the gentle CS, which does not allow the possibility of observing the delivery. Data were collected online and analysed by multivariable regression for quantitative data and content analysis for all text responses to open questions, respectively. RESULTS: 193 women completed the questionnaire. Of these, 154 had a gentle CS and 39 had an extended gentle CS. Multivariable regression did not reveal a statistically significant difference for extended gentle CS with regard to satisfaction with childbirth, mother-to-child bonding, or breastfeeding duration. Nevertheless, early intraoperative skin-to-skin contact was associated with the fulfilment of birth expectations. Furthermore, most women who experienced an extended gentle CS would prefer the same procedure for any potential future CS. CONCLUSIONS: Although our study showed no statistically significant difference in satisfaction from using a transparent drape, most women expressed a preference for this technique. We recommend that the option of an extended gentle CS should be offered to all women for whom CS is indicated.

High prevalence of severe vitamin D deficiency during the first trimester in pregnant women in Switzerland and its potential contributions to adverse outcomes in the pregnancy.

PURPOSE: Vitamin D is primarily known for its role in bone health. However, it has a much more diverse role in the human metabolism. Specifically, deficiency of vitamin D has recently been studied for its possible role in adverse pregnancy outcomes such as preeclampsia, gestational diabetes and preterm birth. Vitamin D levels largely depend on exposure to the sun and are influenced by nutritional habits at only a minimal level. In Switzerland, it is estimated that 40–50% of the population is vitamin D deficient. No specific data on pregnant women is available. The recommendations of the Swiss Federal Commission for Nutrition include a supplement of 600 IU of vitamin D to all pregnant women, despite the lack of data for this population in Switzerland. The primary aim of this study was to determine the prevalence of vitamin D deficiency among the population of pregnant women receiving prenatal care and giving birth at our clinic. We assumed that the prevalence of vitamin D deficiency in pregnant women in Switzerland is significantly higher than what has been estimated. Therefore, the current recommendations for vitamin D supplementation in pregnant women may be insufficient to achieve appropriate vitamin D levels. Furthermore, we aimed to address the issue of the potential influence of vitamin D deficiency on adverse pregnancy outcomes. METHODS: We performed a retrospective, observational cross-sectional study of 1382 pregnant women attending prenatal care at our department between 2012 and 2015. Serum 25-dihydroxycholecalciferol (25(OH)D) levels were determined in the first trimester, and the patient’s characteristics, the course of the pregnancy, any complications, the delivery and the neonatal outcome were analysed. The risk factors for vitamin D deficiency and its correlation with adverse pregnancy outcomes were assessed using a multivariate analysis. RESULTS: The clear majority (73.23%) of the population studied were found to be vitamin D deficient, with serum levels of 25(OH)D <50 nmol/l. More importantly, severe vitamin D deficiency (25(OH)D levels below 25 nmol/l) was present in one third (34.2%) of all pregnant women. The mean 25(OH)D level was 36.72 ± 19.63 nmol/l. In the multivariate analysis, those with a high BMI and who belonged to ethnicities comprising people who are generally dark-skinned were found to be associated with lower 25(OH)D serum levels (p <0.0001). We detected a seasonal influence: the mean 25(OH)D level was significantly higher during the summer season (April–September) compared to the winter season (October–March) (p <0.0001). We found an association between low 25(OH)D serum level and gestational diabetes (p = 0.0116). Surprisingly, a low 25(OH)D level was also associated with decreased incidence of postpartum hemorrhage and placental retention (p = 0.02). We found no association between the 25(OH)D serum level and preeclampsia, preterm birth, postdate pregnancy, miscarriage, intrauterine growth restriction, bacterial vaginosis, mode of delivery, or neonatal birth weight and length. CONCLUSION: We performed a retrospective analysis of serum 25(OH)D concentrations in pregnant Swiss women and found a mean serum 25(OH)D level of about 37 nmol/l and that one third of the overall study population had a serum 25(OH)D level below 25 nmol/l, and were thus seriously vitamin D deficient. Furthermore, the data demonstrate that vitamin D deficiency is associated with gestational diabetes. The current recommendations of vitamin D supplementation of 600 IU in pregnant women are therefore insufficient, and novel strategies, such as general screening for vitamin D deficiency, pre-conceptional timing of the supplementation and individually tailored dosing of vitamin D supplementation seem mandatory, potentially leading to improved maternal health and benefits to children’s long-term health in Switzerland and worldwide. (trial registration ClinicalTrial.gov. Identifier: NCT02904720).

Intravenous iron treatment in pregnancy: comparison of high-dose ferric carboxymaltose vs. iron sucrose.

OBJECTIVE: Oral iron substitution has shown to be insufficient for treatment of severe iron deficiency anemia in pregnancy. Ferric carboxymaltose is a new intravenous (i.v.) iron formulation promising to be more effective and as safe as iron sucrose. We aimed to assess side effects and tolerance of ferric carboxymaltose compared to i.v. iron sucrose in pregnant women. METHODS: We performed a retrospective analysis of 206 pregnant women who were treated either with ferric carboxymaltose or iron sucrose for iron-deficiency anemia with intolerability to oral iron substitution, or insufficient hemoglobin increase after oral iron treatment, or need for rapid hemoglobin reconstitution. Primary endpoint was to evaluate the maternal safety and tolerability. Secondary endpoint was to assess efficacy of the treatment and exclude safety concerns for the fetus. RESULTS: The incidence of drug-related adverse events was low and mostly mild in both groups. Mild adverse events occurred in 7.8% for ferric carboxymaltose and in 10.7% for iron sucrose. The mean rise of hemoglobin value was 15.4 g/L for ferric carboxymaltose and 11.7 g/L for iron sucrose. CONCLUSION: Ferric carboxymaltose administration in pregnant women is well tolerated and is not associated with any relevant clinical safety concerns. Ferric carboxymaltose has a comparable safety profile to iron sucrose but offers the advantage of a much higher iron dosage at a time reducing the need for repeated applications and increasing patients' comfort. Ferric carboxymaltose is the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.

Safety and efficacy of high-dose intravenous iron carboxymaltose vs. iron sucrose for treatment of postpartum anemia.

OBJECTIVE: The purpose of this study is to compare the safety and efficacy of intravenous (IV) high-dose iron carboxymaltose (ICM) with iron sucrose (IS) for the treatment of postpartum anemia. STUDY DESIGN: We performed a retrospective cohort study with 210 anemic inpatient women in the postpartum period who received IV high-dose ICM (15 mg/kg; maximum, 1000 mg) or IS (2×200 mg), respectively. Safety and tolerability of both groups were compared on the basis of reported systemic and local adverse events. The cohorts were matched for baseline characteristics and their initial hemoglobin (Hb) values. The secondary endpoint included drug efficacy assessment by measurement of Hb level increase up to 8 days after treatment. RESULTS: Rapid administration of high ICM doses was as well tolerated as IS with overall adverse events of 5% (ICM) vs. 6% (IS). The most common complaint was burning and pain at the injection site. ICM was as effective as IS in changing Hb levels from the baseline. There was no difference in the mean daily Hb increase between the groups. Women with severe anemia showed the most effective responsiveness. CONCLUSIONS: IV ICM is as safe as IS in the management of postpartum (IDA) iron deficiency anemia despite five times of higher dosage. Both drugs are effective and offer a rapid normalization of Hb after delivery. The single application of ICM shows advantages of lower incidence of side effects at the injection site, a shorter treatment period, and better patient compliance.

Comparison of a microporous thermoplastic polyurethane-covered stent with a self-expanding bare nitinol stent in a porcine iliac artery model.

PURPOSE: To compare outcomes with a thermoplastic polyurethane (TPU)-covered self-expanding nitinol stent-graft (TPU graft) with those of a bare self-expanding nitinol stent in a porcine model. MATERIALS AND METHODS: Fourteen TPU grafts and 14 commercially available bare nitinol stents were implanted, one each, in the iliac arteries of 14 minipigs. Follow-up was performed at 1 week (six animals), 4 weeks (four animals), and 12 weeks (four animals). The primary study endpoint was in-stent stenosis assessed with quantitative angiography and microscopy. Secondary endpoints were injury, inflammation, and endothelialization. RESULTS: After 1 week, the maximum percentage luminal loss was significantly greater in TPU grafts (average, 16.2%; range, 0.0%-35.8%) than in bare nitinol stents (8.2%; 0.0%-17.3%) (P = .04). Three of the four TPU grafts were occluded after 4 weeks, and all four TPU grafts were occluded after 12 weeks. Binary stenosis was seen in three of four bare nitinol stents after both 4 and 12 weeks. At 4-week follow-up, the average percentage luminal loss was significantly greater in TPU grafts (85.2%; 40.8%-100%) than in bare nitinol stents (49.5%; 37.9%-62.4%) (P = .003). The difference in neointimal height and percentage average stenosis between TPU grafts (1,028.7 microm and 68.4%) and bare nitinol stents (1,033.6 microm [918.0-1,118.40 microm] and 68.1% [60.44%-71.99%]) was not statistically significant. After 12 weeks, the average percentage luminal loss was 100% in TPU grafts due to occlusion of all stent-grafts and 24.9% (8.0%-63.9%) in bare nitinol stents (P = .011). CONCLUSIONS: TPU grafts failed to provide improved patency compared with the bare nitinol stents because of excessive neointimal growth and subsequent occlusion. In addition, the bare nitinol stents showed considerable in-stent stenosis at angiography and microscopy.

Efficacy of a polyphosphazene nanocoat in reducing thrombogenicity, in-stent stenosis, and inflammatory response in porcine renal and iliac artery stents.

PURPOSE: It is hypothesized that the inorganic polymer poly[bis(trifluoroethoxy)phosphazene] (PTFEP) reduces stent-associated thrombosis, in-stent stenosis, and inflammatory response and stimulates reendothelialization in a porcine model. MATERIALS AND METHODS: PTFEP-nanocoated and bare stainless-steel stents (316 L) were implanted bilaterally in renal and iliac arteries of 16 minipigs (1, 4, and 12 weeks follow-up durations). Primary study endpoints were thrombogenicity determined by filling defects on angiography and in-stent stenosis assessed by lumen loss on quantitative angiography (ie, percentage stenosis) and light microscopy (ie, neointimal thickness, neointimal area, area stenosis). Secondary endpoints were inflammatory response and reendothelialization evaluated by light microscopy and scanning electron microscopy (SEM), respectively. RESULTS: Stent placement was successful in 32 renal and 26 iliac arteries. At follow-up, there were no thrombus depositions on PTFEP-coated renal and iliac stents. Thrombus depositions were found on two of six bare metal iliac stents after 4 weeks (P = .0651). PTFEP-coated stents showed a trend toward reduced in-stent stenosis in all renal and iliac arteries at all intervals: in iliac stents, neointimal area was significantly smaller in coated stents than in bare metal stents after 1 week and 4 weeks (P = .03 and P = .001, respectively). In renal arteries, inflammation scores indicated lower inflammatory response in PTFEP-coated stents than in bare metal stents after 1 week (P = .01). After 1 week, coated and bare metal stents exhibited complete reendothelialization on SEM. CONCLUSIONS: PTFEP-coated stents exhibited reduced thrombus deposition and a trend toward less in-stent stenosis and inflammatory response than bare metal stents.

The efficacy of nanoscale poly[bis(trifluoroethoxy) phosphazene] (PTFEP) coatings in reducing thrombogenicity and late in-stent stenosis in a porcine coronary artery model.

OBJECTIVES: Previous experimental studies have demonstrated that poly[bis(trifluoroethoxy)phosphazene] (PTFEP) nanocoated stents have antithrombotic characteristics, reduce in-stent stenosis, prevent wall inflammation, and do not hamper endothelialization. This study was designed to validate these findings in a porcine coronary artery model. MATERIALS AND METHODS: PTFEP-coated (n = 15) and bare stents (n= 13) were implanted in coronary arteries of 18 mini-pigs (4- and 12-week follow-up). Primary study endpoints were thrombogenicity and in-stent stenosis, secondary study endpoints were inflammatory response and re-endothelialization evaluated by quantitative angiography and light microscopy. RESULTS: No thrombus deposition occurred on any stent. At 4 weeks follow-up, the bare stents (n = 4) had a significantly smaller neointimal area (1.93 vs. 3.20 mm(2), P = 0.009). At 12 weeks, PTFEP-coated stents (n = 11) had significantly superior results in almost all parameters: neointimal area (2.25 vs. 2.65 mm(2), P = 0.034), neointimal height (204.46 vs. 299.41 microm, P = 0.048), percentage stenosis (38.25 vs. 50.42%, P = 0.019), and inflammation score (0.12 vs. 0.30, P = 0.029). Complete re-endothelialization was seen in both stent types at both intervals. CONCLUSION: At long-term follow-up, the superior results of PTFEP-coated stents were characterized by a noteworthy reduction of neointimal growth and inflammatory response.