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P Bergsjø

Publications and source records attributed to P Bergsjø.

At least 19 recordsLinked to original sources
PubMed2001

WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care.

BACKGROUND: We undertook a multicentre randomised controlled trial that compared the standard model of antenatal care with a new model that emphasises actions known to be effective in improving maternal or neonatal outcomes and has fewer clinic visits. METHODS: Clinics in Argentina, Cuba, Saudi Arabia, and Thailand were randomly allocated to provide either the new model (27 clinics) or the standard model currently in use (26 clinics). All women presenting for antenatal care at these clinics over an average of 18 months were enrolled. Women enrolled in clinics offering the new model were classified on the basis of history of obstetric and clinical conditions. Those who did not require further specific assessment or treatment were offered the basic component of the new model, and those deemed at higher risk received the usual care for their conditions; however, all were included in the new-model group for the analyses, which were by intention to treat. The primary outcomes were low birthweight (<2500 g), pre-eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary-tract infection. There was an assessment of quality of care and an economic evaluation. FINDINGS: Women attending clinics assigned the new model (n=12568) had a median of five visits compared with eight within the standard model (n=11958). More women in the new model than in the standard model were referred to higher levels of care (13.4% vs 7.3%), but rates of hospital admission, diagnosis, and length of stay were similar. The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). For pre-eclampsia/eclampsia the rate was slightly higher in the new model (1.69% vs 1.38%; 0.21 [-0.25 to 0.67]). Adjustment by several confounding variables did not modify this pattern. There were negligible differences between groups for several secondary outcomes. Women and providers in both groups were, in general, satisfied with the care received, although some women assigned the new model expressed concern about the timing of visits. There was no cost increase, and in some settings the new model decreased cost. INTERPRETATIONS: Provision of routine antenatal care by the new model seems not to affect maternal and perinatal outcomes. It could be implemented without major resistance from women and providers and may reduce cost.

Adult↗
PubMed2001

[Suspected large fetus in the last period of pregnancy--a difficult problem].

BACKGROUND: In pregnancy surveillance a large symphysis-to-fundus measure raises several questions concerning delivery. MATERIAL AND METHODS: We review various problems with large for gestation age foetuses, also called macrosomic foetuses. We have performed literature searches mainly through PuBMed, which includes the Medline database. The clinical problem is discussed from the primary care provider's point of view and from those of the patient and the obstetrician. RESULTS: Macrosomia is defined as foetal weight above the 90th percentile, birth weight above 4000 g or 4500 g, or birth weight over + 2 SD of the mean birthweight by age. The diagnosis is difficult, even with various sonographic procedures. Abdominal circumference alone appears to have the same diagnostic value as the use of a combination of biparietal diameter, femur length and abdominal circumference. INTERPRETATION: Based on the literature, labour should not be induced or caesarean section performed in non-diabetic pregnancies unless the estimated foetal weight is above 5000 g. A great number of caesarean sections would have to be performed to avoid a single case of plexus brachialis paresis due to difficult shoulder delivery. The best policy is to await spontaneous birth or to induce birth after the completion of 42 weeks. In pregnancies complicated by diabetes mellitus, there are reasons for selective induction of labour if macrosomia is suspected, and for caesarean section if the calculated birth weight is above 4000 g. As the problem of difficult shoulder delivery cannot be completely avoided, each department should have a strategy to handle such a situation. Various procedures for managing the difficult shoulder delivery are described.

Birth Weight↗
PubMed2001

Methodological considerations on the design and analysis of an equivalence stratified cluster randomization trial.

The World Health Organization and collaborating institutions in four developing countries have conducted a multi-centre randomized controlled trial, in which clinics were allocated at random to two antenatal care (ANC) models. These were the standard 'Western' ANC model and a 'new' ANC model consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. The two models were compared using the equivalence approach. This paper discusses the implications of the equivalence approach in the sample size calculation, analysis and interpretation of results of this cluster randomized trial. It reviews the ethical aspects regarding informed consent, concluding that the Zelen design has a place in cluster randomization trials. It describes the estimation of the intracluster correlation coefficient (ICC) in a stratified cluster randomized trial using two methods and reports estimates of the ICC obtained for many maternal, newborn and perinatal outcomes. Finally, it discusses analytical problems that arose: issues encountered using a composite index, heterogeneity of the intervention effect across sites, the choice of the method of analysis and the importance of efficacy analyses. The choice of the clustered Woolf estimator and the generalized estimating equations (GEE) as the methods of analysis applied is discussed.

Adult↗
PubMed2001

Anemia in pregnancy in the highlands of Tanzania.

BACKGROUND: Anemia in pregnancy is common in Tanzania, but many areas have not been investigated. This study describes prevalence and determinants of anemia among rural pregnant women living at 1300-2200 meters above sea level in Northern Tanzania. METHODS: Three thousand eight hundred and thirty-six pregnant women from two rural divisions of Mbulu and Hanang districts attending antenatal clinic between January 1995 and March 1996 were assessed in a cross-sectional study. Blood samples were examined for hemoglobin concentration (Hb) and thick blood slide (BS) for malaria. Information on date of examination, village, age, ethnic and religious affiliation, gestational age, and parity was recorded. Altitude was derived from official maps. Main outcome measures were mean Hb level and risk of anemia defined as a Hb of less than 9.0 g/dl. RESULTS: Hb levels ranged from 4.5 to 18.1 g/dl, and mean was 12.1 g/dl. Twenty-three per cent had a Hb of less than 11 g/dl, 4.6% less than 9 g/dl and 0.5% less than 7 g/dl; standardized to sea level 36.1%, 8.8%, and 1.1%, respectively. The mean Hb increased by 0.3 g/dl per 200 m increased altitude, and the risk of anemia decreased with a factor of 0.6 per 200 m increased altitude. We found higher risk of anemia at higher maternal age (1.2 times increased risk per 5 years). Furthermore, the Datoga tribe had twice the risk of anemia compared with the Iraqw. The risk of anemia was only half at 3-4 months of gestation compared to at 7-8 months. The risk increased six-fold in the rainy season of 1995, and the risk was almost double among those with malaria parasitemia. CONCLUSIONS: Anemia in pregnancy was common in this area of high altitude in rural Tanzania, but less prevalent than indicated by studies from most other parts of the country. The study confirms that preventing anemia is a challenge in preventive antenatal care in the highlands of Tanzania. Studies focussing on the specific etiologic agents are needed.

Adolescent↗
PubMed2000

[Pre-eclampsia--a review].

BACKGROUND: Preeclampsia is characterized by hypertension and proteinuria with or without oedema. MATERIAL AND METHODS: The authors highlight some aspects of preeclampsia: epidemiology, classification, clinical evaluation and treatment. RESULTS: The condition may be classified as light or severe. Preeclampsia can induce damage to the placenta, liver, kidneys and brain, in addition to complications like the HELLP syndrome, placental abruption and eclampsia. Thrombocyte activation may cause activation of the coagulation system and thrombocytopenia. Early onset preeclampsia (< 34 weeks) is often associated with placental infarcts and reduced fetal growth. INTERPRETATION: We focus on early signs and close clinical surveillance. The diastolic blood pressure should be estimated with Korotkoffs' phase V. Patients with early onset preeclampsia should be hospitalized, as should women with hypertension and newly developed proteinuria. Antihypertensive treatment is discussed. Cases with reduced fetal growth and those with severe preeclampsia should in most cases be delivered preterm. Vaginal delivery is preferable. Labour may be induced by oxtocin, following cervical prostaglandin stimulation as indicated. In such cases cardiotocography surveillance during labour should be performed. Caesarean section may be performed in selected cases. Patients with mild preeclampsia can await spontaneous vaginal delivery at term, but delivery should be induced if they proceed past term.

Blood Pressure Determination↗
PubMed2000

Estimates of maternal mortality by the sisterhood method in rural nothern Tanzania: a household sample and an antenatal clinic sample.

OBJECTIVE: To estimate maternal mortality in two samples of a population in northern Tanzania. SETTING: Rural communities and antenatal clinics, Mbulu and Hanang districts, Arusha region, Tanzania. POPULATION: From a household survey 2,043 men and women aged 15-60, and from an antenatal clinic survey 4,172 women aged 15-59. METHOD: The indirect sisterhood method. MAIN OUTCOME MEASURES: The risk of maternal deaths per 100,000 live births (maternal mortality ratio), and the lifetime risk of a maternal death. RESULTS: The risk of a maternal death per 100,000 live births was 362 (95% CI 269-456) and 444 (95% CI 371-517) for the household and antenatal clinic surveys, respectively. The lifetime risk of maternal death was 1 in 38 and 1 in 31, respectively, for the two surveys. A significantly lower risk of maternal death was observed for the respondents attending antenatal clinics closer to the hospital than for those attending clinics further away: 325 (95% CI 237-413) compared with 561 (95% CI 446-677) per 100,000 live births. Lifetime risk of maternal death was 1 in 42 and 1 in 25, respectively. CONCLUSIONS: The risk of maternal death per 100,000 live births in this area were comparatively high, but in our survey substantially lower than in previous surveys in Tanzania. Increasing distance from the antenatal clinics to the hospital was associated with higher maternal mortality. There was no significant difference between results based on household and antenatal clinic data, suggesting that accessible health facility data using the sisterhood method may provide a basis for local assessment of maternal mortality in developing countries.

Adolescent↗
PubMed2000

The diagnosis of urinary tract infections among pregnant women in rural Tanzania; prevalences and correspondence between different diagnostic methods.

BACKGROUND: To assess the prevalence of dysuria, dipsticks positive on nitrite and leukocyte esterase and positive Uricult dip slides among pregnant women in rural Tanzania. METHODS: 3,715 pregnant women were examined for dysuria and had their urine tested with nitrite and leukocyte esterase dipsticks and Uricult dipslides, at their first antenatal visit in 1995-96. RESULTS: The prevalences of positive symptoms and tests were as follows: dysuria 32%, nitrite 40.3%, leukocyte esterase 65.6%, and Uricult dip slides 16.4%. A general log-linear model where all four variables were analyzed simultaneously showed poor correspondence between the diagnostic methods. Odds ratio with 95% confidence intervals were as follows: dysuria vs. nitrite [1.6 (1.4 1.8)]. dysuria vs. leukocyte esterase [1.2 (1.0-1.4)], nitrite vs. leukocyte esterase [4.2 (3.6-4.9)], and leukocyte esterase vs. Uricult [1.4 (1.1-1.7)]. Dysuria and nitrite were not associated with Uricult dipslide. CONCLUSION: A high prevalence of positive tests, but a poor correspondence between the methods was found, emphasizing the need for more attention to the problem of urinary tract infections among pregnant women in developing countries, and the need for better screening tests for urinary tract infections in these countries.

Adolescent↗
PubMed1999

Normobaric oxygen treatment during radiotherapy for carcinoma of the uterine cervix. Results from a prospective controlled randomized trial.

BACKGROUND AND PURPOSE: Hypoxia, a frequent characteristic of cervical cancer, is associated with reduced sensitivity to irradiation and thus may be a source of radiotherapy failure. This study was planned to test the hypothesis, that inhalation of oxygen during radiotherapy may increase the radiation effect on the tumor and improve loco-regional control and overall survival. MATERIAL AND METHODS: From 1963 to 1965, a consecutive series of 208 patients with cervical cancer stage II/III who were to be treated by external irradiation plus radium inserts, were included in this study. They were randomly assigned to either receive oxygen inhalations during the radiotherapy sessions or just breathing air. Due to technical reasons the oxygen group was divided. For the first 10 months, they did receive oxygen during the radium inserts only, the last 13 months during all radiotherapy sessions. RESULTS: After median 33 years follow-up, there are no differences in overall survival, cancer-specific survival or loco-regional control. Subgroup analysis shows significantly improved loco-regional control in the stage IIB patients, with squamous cell carcinoma who received oxygen during all radiotherapy sessions. This improvement was especially pronounced among the patients who also received blood transfusions. CONCLUSIONS: There was no influence of normobaric oxygen treatment on the overall outcome to radiotherapy in patients with stage II cervical cancer, but subgroup analyses support the hypothesis that there is tumor areas of hypoxia-based radioresistance that may be counteracted by oxygen administration.

Adult↗
PubMed1998

The practice of antenatal care: comparing four study sites in different parts of the world participating in the WHO Antenatal Care Randomised Controlled Trial.

In the preparation of a randomised controlled trial to evaluate a new programme of antenatal care (ANC) in different parts of the world, we conducted a baseline survey of the ANC procedures in all 53 clinics participating in the trial. There were two components of this survey: (1) description of clinic characteristics and services offered: the staff of each clinic was interviewed and direct observation was made by field supervisors, and (2) the actual use of services by pregnant women attending these clinics: we reviewed a random sample of 2913 clinical histories. The clinical units surveyed were offering most of the activities, screening, laboratory tests and interventions recommended as effective according to the Cochrane Pregnancy and Childbirth Database (PCD), although some of these were not available in some sites. On the other hand, some tests and interventions that are considered not effective according to these criteria are reportedly offered. There was a difference across sites in the availability and offer to low-risk women of vaginal examination, evaluation of pelvic size, dental examination, external version for breech presentation and formal risk score classification, and a notable difference in the type of principal provider of ANC. There was a large variation in the actual use of screening and laboratory tests and interventions that should be offered to all women according to Cochrane PCD criteria: some of these are simply not available in a site; others are available, but only a fraction of women attending the clinics are receiving them. The participating sites all purport to follow the traditional 'Western' schedule for ANC, but in three sites we found that a high percentage of women initiate their ANC after the first trimester, and therefore do not have either the recommended minimum number of visits during pregnancy or the minimum first trimester evaluation. It is concluded that the variability and heterogeneity of ANC services provided in the four study sites are disturbing to the profession and cast doubts on the rationale of routine ANC.

Argentina↗
PubMed1998

Monitoring data and safety in the WHO Antenatal Care Trial.

A committee to monitor data and safety in a large clinical trial should have members with expertise in biostatistics, epidemiology and the clinical field relevant to the trial. Its mandate should cover both logistics and the safety of study subjects, issues which to some extent overlap. While a steering committee and field staff members ideally should be blinded to the experimental and control arms of a randomised clinical trial, the data and safety monitoring committee (DSMC) should have full access to interim trial data to fulfil its role as watchdog. One initial question to be resolved concerns if and when to advise stopping a trial because of danger to study subjects, or on the other hand obvious benefits, in one trial arm. The DSMC of the WHO Antenatal Care Trial decided not to establish any definite stopping rules before implementation. After a scrutiny of the adopted procedures for data collection and handling, the DSMC received monthly reports of recruitment, and individual summary reports of three adverse events by site and trial arm: maternal deaths, fetal deaths and cases of eclampsia. At the time of writing (December 1997) recruitment to the trial is almost complete, but data collection will continue throughout most of 1998, until every index pregnancy has ended in birth or miscarriage. So far, the balance of untoward events between the intervention and control arms have not given cause for alarm.

Argentina↗