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Aim: Obese women undergoing caesarean section are at increased risk of surgical wound infection, which may lead to reduced quality of life, and increased health care cost. The aim is to evaluate the effect of incisional Negative Pressure Wound Therapy applied prophylactically in obese women undergoing caesarean section.Method: This study is designed as an unblinded, randomised trial. Women with a pre-gestational BMI ≥30 undergoing planned or emergency caesarean section are allocated into one of two groups (incisional Negative Pressure Wound Therapy vs. standard dressing), stratified by centre and type of caesarean section. The dressing is applied immediately following the surgical procedure. In the intervention group the therapy will be left in situ for five days. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Follow-up is 30 days.Conclusion: The study is on-going. We expect to find a 50% reduction of wound infection when using iNPWT compared to standard dressings in this high-risk subpopulation.

Background Obesity among women may influence the risk of degenerative musculoskeletal conditions (MSCs) and contribute to poor quality of life. Parity, which constitutes a sudden natural increase in weight as well it affects long-term body mass index (BMI), may put strain on the musculoskeletal system. The interplay between pre-pregnancy BMI and parity and the risk of MSC is unknown. Aim We conducted this study to examine how pre-pregnancy BMI and parity were associated with long-term risk of MSCs. Methods From the Danish National Birth Cohort, 79,687 mothers with singleton births were included. Information on height and weight prior to pregnancy was obtained from telephone interviews and parity from the Danish Medical Birth Registry. Diagnoses on degenerative MSC including osteoarthritis, disc disorders, low back pain, and soft tissue disorders were obtained from the National Patient Registry. Hazard ratios (HR) were estimated using Cox regression, adjusting for relevant confounders including maternal age. The follow-up started at the day of conception. Results The cumulative incidence of MSCs during a median follow-up of 12.4 years was 19.7%. Risk of MSC increased with both increasing pre-pregnancy BMI and parity. Women, obese prior to conception, had an increased risk of 26% of development of MSCs compared to a normal-weight woman [95% confidence interval 19-34%]. HR of Compared to normal-weight first time mothers, the highest risk was seen in obese women with >2 parities (HR 1.61 [95% confidence interval 1.41-1.83]). Conclusions High pre-pregnancy BMI increased the occurrence of degenerative MSC in the years following pregnancy and childbirth. In combination with increasing pre-pregnancy BMI, higher parity added to an already elevated risk. Prevention of maternal overweight may reduce the development of degenerative MSCs among mothers.

Aim: Postoperative wound complications make many surgical procedures unnecessarily complex, particularly in high-risk patients. Negative Pressure Wound Therapy is well recognized in the management of open wounds. In recent years, it has been introduced as well in the management of closed surgical incisions to reduce postoperative wound complications, though the evidence base to support this intervention is limited. The aim of this study was to assess if Negative Pressure Wound Therapy (NPWT) reduces postoperative complications when applied on closed surgical incisions.Method: A systematic review and meta-analysis of randomized controlled trials of NPWT compared to standard postoperative dressings on closed incisions. Results: Ten studies met the inclusion criteria, reporting on 1344 incisions (1121 patients). NPWT was associated with a significant reduction of wound infection (46%), and seroma formation (52%) compared to standard care. The reduction in wound dehiscence was not statistically significant. The numbers needed to treat were 3 (seroma), 17 (dehiscence), and 25 (infection). Methodical heterogeneity across studies led to downgrading quality of evidence to moderate for infection and seroma, and low for dehiscence. Conclusion: Compared with standard postoperative dressings, NPWT significantly reduces the rate of wound infection and seroma when applied to closed surgical wounds, but diversity in clinical and methodological aspects of the included studies means that no absolute or general recommendations can be made. Aim: Postoperative wound complications make many surgical procedures unnecessarily complex, particularly in high-risk patients. Negative Pressure Wound Therapy is well recognized in the management of open wounds. In recent years, it has been introduced as well in the management of closed surgical incisions to reduce postoperative wound complications, though the evidence base to support this intervention is limited. The aim of this study was to assess if Negative Pressure Wound Therapy (NPWT) reduces postoperative complications when applied on closed surgical incisions.Method: A systematic review and meta-analysis of randomized controlled trials of NPWT compared to standard postoperative dressings on closed incisions. Results: Ten studies met the inclusion criteria, reporting on 1344 incisions (1121 patients). NPWT was associated with a significant reduction of wound infection (46%), and seroma formation (52%) compared to standard care. The reduction in wound dehiscence was not statistically significant. The numbers needed to treat were 3 (seroma), 17 (dehiscence), and 25 (infection). Methodical heterogeneity across studies led to downgrading quality of evidence to moderate for infection and seroma, and low for dehiscence. Conclusion: Compared with standard postoperative dressings, NPWT significantly reduces the rate of wound infection and seroma when applied to closed surgical wounds, but diversity in clinical and methodological aspects of the included studies means that no absolute or general recommendations can be made.

Background: Obese women undergoing caesarean section are at increased risk of surgical wound complications, which may lead to delayed recovery, pain, reduced quality of life, and increased health care cost. The aim of this study is to evaluate the effect of incisional Negative Pressure Wound Therapy (iNPWT) applied prophylactically following caesarean section compared with standard postoperative dressings in obese women undergoing caesarean section.Method: This study is designed as an unblinded, pragmatic, parallel randomised multicenter trial, with a 1:1 allocation. A computer random number generator are used to allocate the participants into one of two groups (iNPWT vs. standard dressing), stratified by centre and type of CS. The study is conducted at five public hospitals located in three regions of Denmark. Interim analyses will be preformed along the trial using the group sequential method. The analyses will be performed when sample size reaches 179, 357, 535, 713, and 891, respectively. Population: women with a pre-gestational BMI ≥ 30 undergoing planned or emergency caesarean section. The iNPWT or standard dressings is applied immediately following operation. In the intervention group the therapy will be left in situ for five days. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Follow-up is 30 days.Results: The study is on going. The first 179 participants are about to be analysed. Overall we expect to find a 50% reduction of wound infection when using iNPWT compared to standard postoperative dressings in this high-risk subpopulation.

BACKGROUND: The importance of the environment on the development of the fetus and infant throughout early life is increasingly recognised. To study such effects, biological samples and accurate data records are required. Based on multiple data collection from a healthy pregnant population, the Odense Childhood Cohort (OCC) study aims to provide new information about the environmental impact on child health by sequential follow-up to 18 years of age among children born between 2010 and 2012.METHODS: A total of 2874 of 6707 pregnancies (43%) were recruited between January 2010 and December 2012. Three hundred seventy-four have since left the study, leaving 2500 active families. The non-participants act as controls contributing data through local registries. Biological material, questionnaires, and registry data were compiled. Anthropometric data and other physical data were collected.RESULTS: Two thousand five hundred families actively participated in the study with 2549 children. Sixty-four per cent of the fathers and 60% and 58% of the mothers, respectively, donated a blood sample at 10 and 28 weeks of gestation. On average, 69% completed questionnaires, 78% of the children were regularly examined, and had a blood sample taken (46%). The participating pregnant women differed from the non-participants in several respects: age, body mass index, smoking, parity, education, and ethnicity. The infants were comparable with respect to gender and mode of delivery.CONCLUSIONS: The OCC provides material for in-depth analysis of environmental and genetic factors that are important for child health and disease. Registry data from non-participating women and infants are available which ensures a high degree of comparable data.

OBJECTIVES: Failure of blood pressure management often leads to early termination of preeclamptic pregnancies. Preeclampsia is - besides hypertension and proteinuria - characterized by renal sodium retention and suppressed renin-angiotensin system. There is a prominent and aberrant glomerular filtration of the plasma zymogen plasminogen to urine with subsequent activation to plasmin. Urine with plasmin from preeclamptic patients activates the epithelial sodium channel (ENaC) in vitro and there is a positive correlation between urinary total plamin(ogen) and blood pressure in preeclamptic women. It was hypothesized that urine total plasmin/plasminogen activity are biomarkers in preeclampsia that can predict severe preeclampsia. A study was conducted to test if u-plasmin(ogen) could be used as a predictive marker for the development of severe preeclampsiaMETHODS: Longitudinal observational study with consecutive inclusion of 91 women with preeclampsia. Patients were stratified into severe (SPE) and non-severe preeclampsia (non-SPE) (Severe: systolic ⩾160mmHg and/or diastolic ⩾110mmHg and ⩾ +1 for albuminuria on urine dipstick or HELLP syndrome). Blood pressure, plasma, urine and clinical data were collected at debut of preeclampsia and again at follow up and at delivery.RESULTS: Of the listed covariates only a difference in gestational age were observed. There was a significant lower gestational age at SPE debut (inclusion samples) p-value 0.00022 and also at delivery p-value 0.004. A clear indication of a weak correlation was found between u-albumin and u-plasmin(ogen)CONCLUSIONS: In this small cohort u-total plasmin(ogen)/creatinine ratio did not predict the onset of severe preeclampsia. Significant difference in gestational age at debut and delivery in the severe and non-severe preeclampsia groups could support the theory of different phenotypes.DISCLOSURES: B. Frederiksen-Møller: None. B.L. Jensen: None. M.H. Falk: None. J.V. Hjelmborg: None. J.S. Jørgensen: None.

OBJECTIVES: Serine proteases are enzymes involved in digestion, immune response, blood coagulation and reproduction. The serine protease prostasin (PRSS8, CAP1) and its regulatory associated proteins (Matriptase, Hepatocyt growth factor activator inhibitors (HAIs), and Nexin-1) are essential for normal placental development in mice. Prostasin is regulated by aldosterone in the kidney and may activate the epithelial sodium channel (ENaC). Preeclampsia is characterized by disturbed placentation, suppression of aldosterone and avid renal sodium retention with hypertension. It was hypothesized that preeclampsia is associated with low prostasin expression in placenta and spillover of prostasin into urine across the defect glomerular barrier.METHODS: This hypothesis was addressed in a cross-sectional design with 20 healthy pregnant women and 20 women with new onset of preeclampsia (hypertension and 1+ for protein on urine dipstick). Blood and urine samples were obtained in relation to delivery and placental biopsies were taken immediately after delivery (control = 39 and preeclampsia 40 weeks).RESULTS: Women with preeclampsia displayed lower levels of aldosterone in plasma (p=0.0475) and in spot urine normalized for creatinine (p=0.0001). Placental weight was not different between groups. Prostasin, matriptase, HAI 1 and 2, and nexin mRNA abundances were not different in placenta tissue between groups. Prostasin protein level in placental homogenate was not different between groups as judged from western blotting and ELISA assay. Western blotting showed significantly elevated urine excretion of prostasin in preeclamptic patients compared to controls. Plasma aldosterone correlated directly with placental weight (p=0.022), while plasma prostasin did not correlate to aldosterone or placental weight. No correlation between aldosterone and systolic or diastolic blood pressure was found.CONCLUSIONS: It is concluded that altered prostasin activity in placenta in preeclampsia is likely to be at the level of activity and not protein abundance. In perspective, urine prostasin may contribute to renal EnaC activation.DISCLOSURES: B. Frederiksen-Møller: None. J.S. Jørgensen: None. L.K. Vogel: None. B.L. Jensen: None.

OBJECTIVES: Increased activity of the epithelial sodium channel (ENaC) in the kidneys may explain the coupling between proteinuria, edema, suppressed aldosterone and hypertension in preeclampsia. Preeclamptic women excrete plasminogen-plasmin in urine. In vitro, plasmin increases the activity of ENaC by proteolytic cleavage of the γ-subunit ectodomain and release of a 43-aminoacid inhibitory tract from the channel. Exosomes are membrane vesicles released into the urine from apical membranes of the kidney epithelial cells.OBJECTIVES: (1) To investigate if the proteolytic state of the ENaC γ-subnit can be studied in urine exosomes from pregnant women. (2) To investigate if the ENaC γ-subunit ectodomain is abnormally activated by proteolysis in preeclamptic women.METHODS: 100 mL spot urine samples from 14 preeclamptic women, 17 pregnant women and 9 non-pregnant women were collected with protease inhibitors. Plasmin/plasminogen was measured. Exosomes were recovered by ultracentrifugation at 220,000×g at 4°C for 100 min. The exosome fraction was used for western blotting with a newly developed monoclonal antibody, mAb3C7, directed against the "inhibitory" tract in γ-ENaC. Aquaporin-2 (AQP2) was used as a positive control for the presence of collecting duct membrane.RESULTS: Urine plasmin-plasminogen/creatinine ratio was increased in the preeclampsia group (pCONCLUSIONS: It is possible to examine collecting duct transport proteins in urine exosome from pregnant women including γ-ENaC, 2) Urine exosome fraction displays a variable pattern of γ-ENaC signal with a predominance of cleaved forms in both normal and preeclamptic women.DISCLOSURES: M.R. Nielsen: None. M. Rytz: None. B. Frederiksen-Møller: None. P. Svenningsen: None. R.M. Zachar: None. J.S. Jørgensen: None. B.L. Jensen: None.

Objective To examine the experience of women with a pre-pregnant BMI >30 kg/m 2, in their encounters with healthcare professionals during pregnancy. Design Qualitative study using a phenomenological methodology approach. Setting Face-to-face interviews with pregnant women in their own home who were referred from their general practitioner to specialist antenatal follow-up at their local hospital. Sample Sixteen women with pre-pregnant BMI >30 kg/m 2. Methods Qualitative in-depth interviews. Participant's experiences of their encounters with health care professionals were recorded verbatim, transcribed and analysed using a phenomenological approach. Results Two main themes were identified, an accusatorial response from healthcare professionals and a lack of advice and helpful information on how being obese and pregnant might affect the women's health and that of their child. Conclusions Pregnant women with obesity may experience prejudice from healthcare professionals. These women felt they were treated with a lack of respect, an accusatorial response, and the feeling that information which could have been helpful was not forthcoming. Communication between obese pregnant woman and healthcare professionals appears to be lacking. Improved training in communication skills, less judgemental behaviour and better dissemination of information from healthcare professionals working with pregnant women with obesity are needed.

Purpose: To examine the effect on wound healing, using Negative Pressure Wound Therapy (NPWT) compared with standard wound dressings in women, who experience spontaneous dehiscence or reoperation due to infection or hematoma after caesarean section. In addition, an analysis of the health economic cost and consequences of NPWT is planned.Methods: A randomized controlled trial. The study will be performed at two large obstetrical units in Denmark. Data will be collected prospectively. We expect to include 50 women, of whom two-thirds will be randomized to NPWT. The primary endpoint is the frequency of re-rupture in each group. The secondary endpoints are a cosmetic outcome score and a Quality of Life score.Preliminary results: Fifteen women have so far been included, of whom 93% were re-sutured as scheduled on the fourth day postoperatively, 0% experience re-rupture and 7% healed subsequently from the inside. By comparison a review of medical records from 2008 to mid-2010 found that out of 19 women 58% were re-sutured, 21% experience re-rupture and 30% healed from the inside. An economic calculation has shown that it requires four changes of wound dressing with conventional wound treatment for one change with NPWT to be cost effective.Concussion: The preliminary results indicate that NPWT reduce the risk of re-rupture significantly. The benefit of the treatment is expected to be twofold:a) A reduction in health care costs (inpatient bed days and readmissions)b) An increase in the women's health related quality of life

The purpose of this study is to examine the effect on wound healing using Negative Pressure Wound Therapy (NPWT) compared with conventional wound treatment in women, who experience spontaneous dehiscence or reoperation for postoperative infection after caesarean section (CS). In addition the study seeks to elucidate the health economic cost and consequences of this type of infection and treatment.Background: Obesity is an increasing problem in the health care system. Today more than 12% of all pregnant women in Denmark are obese (BMI >30). There is a significant association between obesity in pregnant women and the risk of CS. Obesity is associated with an increased risk of postoperative complications such as wound infection, spontaneously dehiscence or reoperation due to infection and prolonged wound healing. Postoperative complications lead to higher costs in the health care sector, including time of health professionals, prolonged hospitalization, medications, blood samples and -cultures, reoperations and visits to the general practitioner. Complications may also lead to productivity losses and reduced quality of life. At Odense University Hospital (OUH), Denmark, the conventional treatment of post-CS infection requires hospital re-admission and re-operation for opening and debridement of the infected wounds under regional- or general anesthesia. The wound is normally re-sutured on the fourth day. NPWT is an alternative method of conservative wound management, which uses negative pressure to promote wound healing in both chronic and acute wounds. The rationale for using NPWT is, that it mechanically stimulates the formation of new tissue and removes wound fluid and infectious material.Methods: A randomized controlled trial with concurrent economic evaluation. In collaboration with the department of plastic surgery at OUH, this study will be performed at two large obstetrical units at OUH and Hvidovre Hospital with more than 10000 deliveries and 2500 CS’s annually. Data will be collected prospectively from 1) self-administered questionnaires 2) registration forms registering used wound dressings. 3) medical records. We expected to include approximately 50 women, of whom two-thirds will be randomized to NPWT.Preliminary results: Four women were included in a pilot project at the obstetrical ward at OUH. Three women were re-sutured as scheduled on the fourth day after the reoperation (two with NPWT and one having the conventional treatment). One woman (NPWT) was re-operated several times and her wound healed subsequently from the inside, which lasted approximately three months. The poor wound healing probably resulting from extreme obesity (BMI >47). An economic calculation has shown that it requires four changes of wound dressing with conventional wound treatment for one change with NPWT to be cost effective. If the change of wound dressing is performed evening or night, the cost increases in the control group due to higher hourly wages.

Background Even though midwifery and obstetrics are usually associated with joyous events, they entail rare cases of the midwife or doctor being involved in so-called traumatic birth incidents, where the baby is born with severe and possibly fatal injuries related to the birth. When such complications arise in the delivery room, the incident is assessed in order to clarify whether the adverse event could have been avoided. The subsequent management of employee reactions mainly regards organizational practice, where the most important question is what lessons can be learned from the incidents. While the organization has had a significantly increased focus on patient safety over the past decade, the individual midwife’s and doctor's professional and personal reactions and management of a traumatic childbirth have not been equally considered. The lack of research within this field is in stark contrast with studies showing that both midwives and doctors have a high incidence of work-related mental health problems, such as depression, burn-out and stress. This poses a problem, not only to the employees, but also to the patients, as emerging research has shown that the emotional state of the health care professionals can influence their clinical performance and impact patient safety.The overall purpose of this study is to investigate how midwives and obstetric doctors experience and cope with involvement in traumatic childbirths, hence contributing to a more qualified management of the af-termath of such incidents.Methods The study has a mixed methods approach consisting of a quantitative questionnaire survey and a qualitative interview study, thus allowing a descriptive as well as an exploratory dimension. QuestionnaireA questionnaire will be sent to all midwives and obstetric consultant and trainees in Denmark, adding up to a total of 2400. The overall aim of the survey is to identify the proportion of midwives and obstetricians who have been involved in one or more traumatic childbirths. Subsequently the aim is to investigate the correlation between traumatic childbirths and work-related mental health problems among midwives and obstetricians and finally to explore the coping strategies of the midwives and obstetricians related to their personal values, faith and convictions.Qualitative interviewsThe qualitative part of the study will consist of 16-20 individual semi-structured interviews, equally distributed between midwives and doctors, which will provide a deeper understanding and contextualization than the questionnaire allows. Expected resultsThis project will in a Danish context contribute to scientific knowledge in a field that previously has not been investigated. Knowledge about how midwives and obstetricians experience being involved in traumatic childbirths will serve to improve the management of the aftermath of the traumatic events from the perspective of the healthcare professionals. Such improvements could be important in the effort to prevent work-related mental health problems amongst midwives and doctors. In addition, the results will be of interest in an increased safety culture, acknowledging that the emotional state of the health care profes-sionals has an impact on patient safety.