The consistency of experts' evaluation of obstetric claims for compensation.

OBJECTIVE: The aim of this study was to investigate the consistency of experts' evaluation of different types of obstetric claims for compensation. DESIGN: Inter-rater reliability study of obstetric claims for compensation. SETTING: Medical experts' evaluation in The Norwegian System of Compensation to Patients, a no-blame system. SAMPLE: The 15 most frequently used medical experts were asked to evaluate 12 obstetric claims applied for compensation. METHODS: Inter-rater agreement was assessed by absolute agreement, Fleiss' kappa statistic and Gwet's AC1. MAIN OUTCOME MEASURES: Consistency in the evaluation of negligence (carelessness without intention to harm) and causality (relation between care and injury) between negligence and patient injury. RESULTS: The experts demonstrated moderate consistency in their evaluation of negligence (Fleiss' kappa = 0.53/AC1 = 0.54) and causality (Fleiss' kappa = 0.41/AC1 = 0.54). There was a higher level of agreement in clinical scenarios with well-documented diagnostic criteria and guidelines, including shoulder dystocia and asphyxia with low Apgar score and metabolic acidosis. CONCLUSION: We found a moderate level of agreement in experts' evaluation of negligence and causality between the injury and provided health care, the two most important questions to be answered in obstetric claims for compensation.

Risk factors for obstetric anal sphincter injury after a successful multicentre interventional programme.

OBJECTIVE: To evaluate and compare the risk profile of sustaining obstetric anal sphincter injuries (OASIS) and associated risks in five risk groups (low to high), after the OASIS rate was reduced from 4.6% to 2.0% following an interventional programme. The main focus of the intervention was on manual assistance during the final part of second stage of labour. DESIGN: A multicentre interventional cohort study with before and after comparison. SETTING: Four Norwegian obstetric departments. SAMPLE: A total of 40,154 vaginal deliveries in 2003-09. METHODS: Pre-intervention and postintervention analyses. The associations of OASIS with possible risk factors were estimated using odds ratios obtained by logistic regression. MAIN OUTCOME MEASURE: Risk factors of OASIS. RESULTS: The risk of sustaining OASIS decreased by 59% (odds ratio [OR] 0.41; 95% confidence interval [95% CI] 0.36-0.46) after the intervention. Associations with obstetric risks for OASIS were largely unchanged after the intervention, including first vaginal delivery (OR 3.84; 95% CI 2.90-5.07), birthweight ≥ 4500 g (OR 4.42; 95% CI 2.68-7.27), forceps delivery (OR 3.54; 95% CI 1.99-6.29) and mediolateral episiotomy (OR 0.89; 95% CI 0.70-1.12). However, the highest reduction of OASIS, (65%), was observed in group 0 (low-risk) (OR 0.35; 95% CI 0.24-0.51), and a 57% (OR 0.43; 95% CI 0.35-0.52), 61% (OR 0.39; 95% CI 0.31-0.48), and 58% (OR 0.42; 95% CI 0.30-0.60) reduction in groups with one, two and three risk factors, respectively. No change was observed in the group with four risk factors. CONCLUSION: After the intervention the most significant decrease of OASIS was observed in low-risk births, although the main risk factors for OASIS remained unchanged.

Different labour outcomes in primiparous women that have been subjected to childhood sexual abuse or rape in adulthood: a case-control study in a clinical cohort.

OBJECTIVE: To compare the duration and outcome of the first labour in women who have been subjected to childhood sexual abuse (CSA) and women who have been raped in adulthood (RA). DESIGN: Case-control study in a clinical cohort. SETTING: University Hospital of North Norway. SAMPLE: In all, 373 primiparas: 185 subjected to CSA, 47 to RA and 141 controls without a history of abuse. METHODS: Data on birth outcomes were retrieved from the patient files. Information on sexual abuse was reported in consultation with specialised midwives in the mental health team. Birth outcomes were analysed by multinominal regression analysis. MAIN OUTCOME MEASURES: Vaginal births, delivery by caesarean section, operative vaginal delivery and duration of labour. RESULTS: As compared with controls, the RA group showed a significantly higher risk for caesarean section (adjusted OR 9.9, 95% CI 3.4-29.4) and operative vaginal delivery (adjusted OR 12.2, 95% CI 4.4-33.7). There were no significant differences between the CSA and the control group. The RA group displayed significantly longer duration of labour in all phases as compared with the control and CSA groups. CONCLUSIONS: There were major differences in the duration of labour and birth outcomes in the two abuse groups. Despite a higher proportion of obstetric risk factors at onset of labour in the CSA group, women subjected to CSA had shorter labours and less risk for caesarean section and operative vaginal deliveries than women subjected to RA. The best care for birthing women subjected to sexual abuse needs to be explored in further studies.

Episiotomy characteristics and risks for obstetric anal sphincter injuries: a case-control study.

OBJECTIVES: To investigate the association between the geometrical properties of episiotomy and obstetric anal sphincter injuries (OASIS) because episiotomies angled at 40-60° are associated with fewer OASIS than episiotomies with more acute angles. DESIGN: Case-control study. SETTING: University Hospital of North Norway, Tromsø and Nordland Hospital, Bodø, Norway. SAMPLE: Seventy-four women who had one vaginal birth and episiotomy. Cases (n = 37) have sustained OASIS at birth, while controls (n = 37) had not. The groups were matched for instrumental delivery. METHODS: Two groups of women with history of only one vaginal birth were compared. Episiotomy scar was identified and photographed and relevant measures were taken. Data were analysed using conditional logistic analysis. MAIN OUTCOME MEASURES: Mean episiotomy angle, length, depth, incision point. RESULTS: The risk of sustaining OASIS decreased by 70% (odds ratio [OR] 0.30; 95% CI 0.14-0.66) for each 5.5-mm increase in episiotomy depth, decreased by 56% (OR 0.44; 95% CI 0.23-0.86) for each 4.5-mm increase in the distance from the midline to the incision point of the episiotomy, and decreased by 75% (OR 0.25; 95% CI 0.10-0.61) for each 5.5-mm increase in episiotomy length. Lastly, there was no difference in mean angle between groups but there was a "U-shaped" association between angle and OASIS (OR 2.09; 95% CI 1.02-4.28) with an increased risk (OR 9.00; 95% CI 1.1-71.0) of OASIS when the angle was either smaller than 15° or >60°. CONCLUSION: The present study showed that scarred episiotomies with depth > 16 mm, length > 17 mm, incision point > 9 mm lateral of midpoint and angle range 30-60° are significantly associated with less risk of OASIS. Shrinkage of tissue must be considered.

Is the operative delivery rate in low-risk women dependent on the level of birth care? A randomised controlled trial.

OBJECTIVE: To investigate possible differences in operative delivery rate among low-risk women, randomised to an alongside midwifery-led unit or to standard obstetric units within the same hospital. DESIGN: Randomised controlled trial. SETTING: Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Tromsø, Norway. POPULATION: A total of 1111 women assessed to be at low risk at onset of spontaneous labour. METHODS: Randomisation into one of three birth units: the special unit; the normal unit; or the midwife-led unit. MAIN OUTCOME MEASURES: Total operative delivery rate, augmentation, pain relief, postpartum haemorrhage, sphincter injuries and intrapartum transfer, Apgar score <7 at 5 minutes, metabolic acidosis and transfer to neonatal intensive care unit. RESULTS: There were no significant differences in total operative deliveries between the three units: 16.3% in the midwife-led unit; 18.0% in the normal unit; and 18.8% in the special unit. There were no significant differences in postpartum haemorrhage, sphincter injuries or in neonatal outcomes. There were statistically significant differences in augmentation (midwife-led unit versus normal unit RR 0.73, 95% CI 0.59-0.89; midwife-led unit versus special unit RR 0.69, 95% CI 0.56-0.86), in epidural analgesia (midwife-led unit versus normal unit RR 0.68, 95% CI 0.52-0.90; midwife-led unit versus special unit RR 0.64, 95% CI 0.47-0.86) and in acupuncture (midwife-led unit versus normal unit RR 1.45, 95% CI 1.25-1.69; midwife-led unit versus special unit RR 1.45, 95% CI 1.22-1.73). CONCLUSIONS: The level of birth care does not significantly affect the rate of operative deliveries in low-risk women without any expressed preference for level of birth care.

Childhood abuse and caesarean section among primiparous women in the Norwegian Mother and Child Cohort Study.

We examined the association between a history of childhood abuse and caesarean section in the population-based Norwegian Mother and Child Cohort Study (MoBa). Our sample consisted of 26 923 primiparous women with singleton pregnancies at term. Of all women, 18.8% (5060) had experienced any childhood abuse, 14.3% (3856) reported emotional abuse, 5.2% (1413) reported physical abuse and 6.4% (1730) reported sexual abuse. The proportion of caesarean sections before labour was not affected by any childhood abuse. Any childhood abuse was associated with a slightly increased risk of caesarean sections during labour (adjusted odds ratio 1.16; 95% CI 1.03-1.30).

Birth outcomes in primiparous women who were raped as adults: a matched controlled study.

OBJECTIVE: To compare the duration of labour and the birth outcome in a group of primiparous women who had been raped after the age of 16, with a control group from the same birth cohort. DESIGN: Cohort study. SETTING: University Hospital of North Norway. SAMPLE: Fifty women raped as adults and 150 controls. METHODS: Data about birth outcomes in the first pregnancy were collected from the patient files and data concerning the assault were obtained in a subsequent pregnancy through consultations with the women who had been raped. Birth outcomes in the group of women who had been raped were compared with matched controls using a multivariable logistic regression model. MAIN OUTCOME MEASURES: Caesarean section, operative vaginal delivery and duration of labour. RESULTS: During their first delivery, the women who had been raped had an increased risk for caesarean section (adjusted odds ratio 15.7, 95% CI 5.0-49.1) and for assisted vaginal delivery (adjusted odds ratio 13.1, 95% CI 4.9-34.5) when compared with controls. The group of women who had been raped had a longer second stage of labour than the control group (120 versus 55 minutes, P < 0.01). They were more often single mothers, unemployed and smokers, and had a higher body mass index and more previous pregnancy terminations and miscarriages than the control group. CONCLUSIONS: The women who had been raped had a longer second stage of labour, and an increased risk of caesarean section and operative vaginal delivery compared with controls from the general birth cohort. These findings indicate that the consequences for delivery for women who had been raped as adults could be specific and may warrant particular attention. The birth experience of women who had been raped should also be illuminated in future studies.

Neonatal alloimmune thrombocytopenia in Norway: poor detection rate with nonscreening versus a general screening programme.

The implementation of an antenatal screening programme for neonatal alloimmune thrombocytopenia (NAIT) is currently under debate. We evaluated the detection rate for NAIT in a nonscreened population of 661,200 births where NAIT was diagnosed on clinical indication. We did a cross-sectional comparison with a population of 100,448 human platelet antigen 1a (HPA1a)-screened pregnancies from three of the five health regions in Norway. In a nonscreening situation, 7.5 cases of NAIT were detected per year compared with 53 cases when screening was applied. The detection rate of NAIT in Norway was therefore 14% of the expected rate.

Capillary protein leak syndrome appears to explain fluid retention in cancer patients who receive docetaxel treatment.

PURPOSE: The aim of our study was to elucidate whether the fluid retention syndrome induced by docetaxel is caused by capillary protein leakage or by other mechanisms. PATIENTS AND METHODS: Twenty-four patients with advanced or metastatic non-small-cell lung cancer (NSCLC; 23 patients) or metastatic head and neck cancer (one patient) were included on this prospective, nonrandomized trial. Docetaxel 100 mg/m2 was administered every 3 weeks with 5 days of dexamethasone prophylaxis to avoid hypersensitivity reactions and edema formation. Transcapillary forces, ie, colloid osmotic pressure of plasma (COPpl) and interstitial fluid (COPint) and interstitial hydrostatic pressure (Pint), were measured before the start of treatment and after total docetaxel doses of 200 and 500 mg/m2 by means of the well-documented wick and wick-in-needle methods. Body weight, degree of edema, blood pressure, and heart rate and hemoglobin, hematocrit, albumin, and total protein values were registered in parallel. RESULTS: After a total docetaxel dose of 200 mg/m2, COPpl, COPint, and hemoglobin, hematocrit, albumin, and total protein values had decreased significantly; Pint and body weight were unchanged; and only mild edema was observed. These findings suggest a plasma volume increase followed by enhanced fluid filtration to the interstitium. After a cumulative docetaxel dose of 500 mg/m2, the COPpl continued to decrease significantly, but COPint remained unchanged despite a significant increase in mean body weight and edema formation. These observations support the theory of a capillary protein leakage. CONCLUSION: Docetaxel appears to induce an initial enhancement of fluid filtration followed by a capillary protein leakage that leads to edema formation.

Transcapillary forces of the subcutaneous tissue in patients treated with interleukin-2 and alpha-interferon: no capillary protein leak syndrome?

The purpose of this study was to evaluate whether treatment with interleukin-2 (IL-2) and alpha-interferon (IFN-alpha-2a) causes protein leakage from plasma to the interstitium, leading to the so called 'capillary leak syndrome'. This syndrome is supposed to cause dose-limiting side effects such as weight gain, edema and pleural effusions. Seven patients with disseminated malignant melanoma or renal carcinoma were studied before and after 5 and 12 days of treatment. Transcapillary forces were studied by measuring colloid osmotic pressures in plasma and interstitial fluid (on the thorax and ankle) with a 'wick' method. The colloid osmotic pressure in plasma was reduced by 30-35% during treatment, but with corresponding reductions in the interstitium. Hemoglobin, hematocrit, serum albumin and total protein decreased, whereas moderate edemas and weight gain were observed. These results demonstrate that during treatment with IL-2 and IFN-alpha-2a there are both fluid retention and augmented filtration of fluid from the vascular to the interstitial compartment, but no indication for a capillary leak syndrome. This may explain many of the cardiovascular side effects observed during such treatment.

Monocyte-platelet function and protection against cardiovascular disease.

Observational studies reveal a cardioprotective effect of hormone replacement therapy. The precise mechanisms whereby this treatment influences disease risk are not fully understood. Much attention has been paid to changes in lipid and lipoprotein metabolism, but this explains only part of the protective effect. In this short review, the roles of monocyte and platelet function in atherogenesis and thrombus formation are discussed. It is shown that hormone replacement therapy favourably down-regulates monocyte and platelet reactivity, which may be important in explaining the beneficial effect on the risk of cardiovascular disease.

Increased capillary permeability for plasma proteins in oral contraceptive users.

The transcapillary fluid balance was examined in eleven women before administration of a monophasic oral contraceptive (desogestrel 0.15 mg, ethinylestradiol 0.03 mg), and after three and six months of use. The interstitial colloid osmotic pressure was measured by the "wick" method, and the interstitial hydrostatic pressure by the "wick-in-needle" method in subcutaneous tissue on thorax and leg. During the six-month observation period, the following changes were observed: Plasma colloid osmotic pressure decreased (mean 1.8 mmHg, p = 0.047), as well as serum albumin (mean 5.1 g/l, p = 0.0006), total protein concentration (mean 2.8 g/l, p = 0.0006), hemoglobin (mean 0.5 g/dl, p = 0.014) and hematocrit (mean 1.8%, p = 0.047). Blood pressure and body weight remained unchanged, but foot volume showed a significant increase. The colloid osmotic pressure gradient (plasma-interstitium) was significantly reduced. The results indicate an increase in plasma volume in addition to an increased capillary permeability to plasma proteins during oral contraceptive use. We suggest that the observed changes in transcapillary fluid balance is caused by the estrogen component of the oral contraceptive pill.

PIP: Physicians at the University of Tromso in Norway enrolled 11 18-26 year old women in a study to determine the effects of 3 and 6 month low dose oral contraceptives (OC) use on transcapillary fluid dynamics. They measured interstitial fluid colloid osmotic pressure (COPi) of the subcutaneous tissue of the thorax and leg with the wick in needle method. A significant fall in hemoglobin (mean 0.7 g/dl) occurred between 0-3 months of OC use (p=.013) as well as in hematocrit (mean 2.3%, p=.044), serum albumin concentration (mean 4.5g/dl, p=.0028), and serum protein concentration (mean 3.2 g/dl, p=.0083). In addition, foot volume rose on average 92.5 ml (p=.002), but body weight and blood pressure stayed the same. Plasma colloid osmotic pressure (COPp) fell slightly (mean 1.1 mm Hg, p=.08). The COPi and interstitial fluid hydrostatic pressure (Pi) on the thorax and the leg did not change. No further changes in hemoglobin, hematocrit, serum albumin, serum protein concentration, COPp, and foot volume occurred during the last 3 months. During the entire 6 months, the transcapillary colloid osmotic pressure gradient on the leg fell on average 2.7 mm Hg (p=.004). It also fell on the thorax (mean 2 mm Hg) but the decrease was not significant. Between 3-6 months, a significant negative relationship between the change in foot volume and the COPi on the thorax occurred as was the change in serum protein (p=.0021). In fact, the change in serum protein was also negatively correlated with the COPi on the leg (p=.0127). Further the change in serum albumin between 3-6 months was positively correlated with the COPi on the leg (p=.0018). In addition, changes in serum protein were positively associated with the COPp (p=.0465). The researchers believed that the estrogen in the low dose OC induced the changes in transcapillary fluid balance.

Increased arterial adrenaline is highly correlated to blood pressure and in vivo platelet function in pre-eclampsia.

Compared with normotensive pregnant women (n = 13), patients with severe pre-eclampsia (n = 13) had increased arterial plasma adrenaline (P < 0.001), peripheral venous adrenaline (P < 0.01), arterio-venous differences of adrenaline (P < 0.001) and venous concentration of the platelet release product beta-thromboglobulin (P < 0.001). In the pre-eclamptic group, arterial adrenaline correlated with mean blood pressure (r = 0.90, P < 0.001), heart rate (r = 0.78, P < 0.01) and beta-thromboglobulin (r = 0.82, P < 0.001), while in the normotensives adrenaline correlated only with beta-thromboglobulin (r = 0.76, P < 0.01). According to these results, sympathetic adrenal tone is increased in pre-eclampsia and may play a role in the pathogenesis of high blood pressure and platelet activation in this disease.

First- and second-trimester hemoglobin levels. Relation to birth weight and gestational age.

The computerized records of 3074 women who were delivered during the period 1987-1990 were analysed. We studied possible relations of birth weight and gestational age to maternal first- and second-trimester hemoglobin levels. Birth weight and gestational age were taken as outcome variables in a multiple stepwise regression analysis, including factors that might interact with hemoglobin levels. A strong independent inverse correlation between the lowest second-trimester hemoglobin and birth weight was observed. First-trimester hemoglobin levels explained little with regard to birth weight, but had a small negative correlation to gestational age. For gestational age < 259 days we found a strong positive correlation between the first- to second-trimester decrease in hemoglobin and birth weight.

[HELLP syndrome--a life-threatening pregnancy complication]. / HELLP-syndromet--en livstruende svangerskapskomplikasjon.

A serious complication to pregnancy-induced hypertension and preeclampsia is the HELLP syndrome (H - haemolysis, EL - elevated liver enzymes, LP - low platelet count). Perinatal and maternal mortality are reported to be high, 7-60% and 2-24%, respectively. A non-obstetric diagnosis is often made, such as gastrointestinal or haematologic disease. Typical symptoms are epigastric and right upper-quadrant pain and tenderness, nausea and vomiting. Recognition of the clinical and laboratory findings is important, so that early, aggressive therapy can be initiated in order to prevent maternal and perinatal death. We present data from 14 patients with the HELLP syndrome treated in our hospital. There was one intrauterine death. The other infants were discharged in good condition. Two of the patients had eclampsia.

[Postmenopausal hormone replacement and cardiovascular disease]. / Postmenopausal hormonsubstitusjon og hjerte- og karsykdom.

We review the evidence that hormone replacement therapy protects against the development of cardiovascular disease in women. Most studies show that this treatment reduces risk of cardiovascular disease by about 50%. The results are reasonably consistent, and biologically plausible. The protective effects are mediated through effects on lipid metabolism, but also through direct effects on vessel wall physiology and blood flow. The beneficial effect of hormone replacement therapy seems to be most marked in high-risk patients and in women with severe coronary artery disease.