Sociodemographic characteristics and perinatal mortality among singletons in North East Tanzania: a registry-based study.

OBJECTIVES: Sub-Saharan Africa has the highest known perinatal mortality rates in the World, but few studies have assessed the importance of parental sociodemographic characteristics on perinatal mortality in this region. The aim of this study was to estimate how sociodemographic patterns affect perinatal mortality in Northern Tanzania. DESIGN AND SETTINGS: A registry-based study using births from 1999 to 2006 at a hospital in North Eastern Tanzania. PARTICIPANTS AND METHODS: 14 394 singleton births with birthweight 500 g or higher and a known perinatal survival status. Births of women with residence outside the local district who were referred to the hospital for delivery for medical reasons were excluded. RESULTS: Perinatal mortality was 41.1 per 1000 births. Factors independently associated with higher perinatal mortality were: higher paternal age (> 45) compared to age 26-35 (adjusted relative risk (ARR) 2.0; 95% CI 1.4 to 2.8), low paternal education (only primary) compared to secondary or higher (ARR 1.3; 95% CI 1.1 to 1.7), paternal ethnicity other than Chagga or Pare (ARR 1.4; 95% CI 1.1 to 1.7), paternal farming occupation (ARR 1.5; 95% CI 1.1 to 2.2), maternal service occupation (ARR 1.7; 95% CI 1.2 to 2.6), maternal height 150 cm or lower (ARR 1.4; 95% CI 1.0 to 1.8) and residence in the rural or semi-urban area (ARR 1.4; 95% CI 1.1 to 1.7). CONCLUSIONS: There are strong sociodemographic gradients in perinatal mortality in Africa. Paternal social characteristics appear to have stronger influence on perinatal mortality than maternal characteristics. This may reflect social and cultural conditions that need to be considered by policymakers in developing countries.

Maternal HIV status and pregnancy outcomes in northeastern Tanzania: a registry-based study.

OBJECTIVES: The proportion of women delivering with known HIV status in sub-Saharan Africa is not well described. Risk of HIV transmission to newborns is a major concern, but there may also be increased risks for other adverse pregnancy outcomes. DESIGN: Hospital registry. SETTING: North East Tanzania (1999-2006). POPULATION: Singletons (n = 14,444). METHODS: Births were grouped by maternal HIV status and socio-demographic factors predicting HIV status, and associations between status and pregnancy outcomes were studied. MAIN OUTCOME MEASURES: Maternal HIV status, perinatal mortality, prematurity, small for gestational age (SGA), birthweight and low Apgar score. RESULTS: The proportion of mothers with known HIV status increased from 7% before 2001 to 78% after 2004. Single motherhood, rural residence, low maternal education, maternal and paternal farming and higher paternal age were associated with unknown HIV status. About 7.4% (95% CI 6.7-8.1%) of women were HIV infected, with increased likelihood of infection with higher gravidity, single motherhood, rural residence, maternal business or farming occupations and paternal tribe. Compared with HIV-uninfected women, the untreated HIV-infected women had a higher risk of SGA births (adjusted risk ratio [ARR] 1.6; 95% CI 1.1-2.4), preterm birth (ARR 1.8; 95% CI 1.1-2.7) and perinatal death (ARR 1.9; 95% CI 0.95-3.8). Women with unknown HIV status had moderately increased risks. Treated HIV-infected women had a risk similar to that of the HIV-uninfected women for all outcomes, except for low Apgar score. CONCLUSION: HIV testing and infection were associated with socio-demographic factors. Untreated HIV-infected women had higher risks of adverse pregnancy outcomes, and risks were also increased for women with unknown HIV status. There is still a need to increase availability of HIV testing, education and adequate therapy for pregnant women.

Suboptimal care and perinatal mortality in ten European regions: methodology and evaluation of an international audit.

BACKGROUND: A European concerted action (the EuroNatal study) investigated differences in perinatal mortality between countries of Europe. This report describes the methods used in the EuroNatal international audit and discusses the validity of the results. METHODS: Perinatal deaths between 1993 and 1998 in regions of ten European countries were identified. The categories of death chosen for the study were singleton fetal deaths at 28 or more weeks of gestational age, all intrapartum deaths at 28 or more weeks of gestational age and neonatal deaths at 34 or more weeks of gestational age. Deaths with major congenital anomalies were excluded. An international audit panel used explicit criteria to review all cases, which were blinded for region. Subjective interpretation was used in cases of events or interventions where explicit criteria did not exist. Suboptimal factors were identified in the antenatal, intrapartum and neonatal periods, and classified as 'maternal/social', due to 'infrastructure/service organization', or due to 'professional care delivery'. The contribution of each suboptimal factor to the fatal outcome was listed and consensus was reached on a final grade using a procedure that included correspondence and plenary meetings. RESULTS: In all regions combined, 90% of all known or estimated cases in the selected categories were included in the audit. In total, 1619 cases of perinatal death were audited. Consensus was reached in 1543 (95%) cases. In 75% of all cases, the grade was based on explicit criteria. In the remaining cases, consensus was reached within subpanels without reference to predefined criteria. There was reasonable to good agreement between and within subpanels, and within panel members. CONCLUSIONS: The international audit procedure proved feasible and led to consistent results. The results that relate to suboptimal care will need to be studied in depth in order to reach conclusions about their implications for assessing the quality of perinatal care in the individual regions.

The epidemiology of syphilis in pregnancy.

This study evaluated the magnitude, risk factors and outcomes of syphilis in pregnancy in a large cohort of women in four countries participating in the World Health Organization (WHO) antenatal care trial. All women attending the first prenatal care at each selected clinic were enrolled. Screening at the first antenatal visit was routinely performed with either rapid plasma reagin or Venereal Disease Research Laboratory and confirmed by fluorescent treponemal antibody absorption. All women also had the same syphilis tests after delivery. The initial prevalence, the incidence during pregnancy and the overall prevalence of syphilis at delivery were 0.9%, 0.4% and 1.3% respectively. Risk factors for syphilis during pregnancy were younger age for the incidence and older age and a history of stillbirth for the prevalence. Women with syphilis during pregnancy had significantly more adverse outcomes. We support the recommendation that in addition to the initial testing, a second routine test for syphilis ought to be established early in the third trimester even in low prevalence areas.

Anemia in pregnancy in rural Tanzania: associations with micronutrients status and infections.

OBJECTIVE: We studied the association between anemia in pregnancy and characteristics related to nutrition and infections. DESIGN: Cross-sectional study. SETTING: Four antenatal clinics in rural northern Tanzania. SUBJECTS/METHODS: A total of 2547 women were screened for hemoglobin (Hb) and malaria plasmodia in capillary blood and for infections in urine. According to their Hb, they were assigned to one of five groups and selected accordingly, Hb<70 g/l (n=10), Hb=70-89 g/l (n=61), Hb=90-109 g/l (n=86), Hb=110-149 g/l (n=105) and Hb> or =150 g/l (n=50). The 312 selected subjects had venous blood drawn, were interviewed, and their arm circumference was measured. The sera were analyzed for ferritin, iron, total iron binding capacity (TIBC), cobalamin, folate, vitamin A, C-reactive protein (CRP), and lactate dehydrogenase (LD). Transferrin saturation (TFsat) was calculated. Urine was examined by dipsticks for nitrite. MAIN OUTCOME MEASURES: Unadjusted and adjusted odds ratio (OR and AOR) of anemia with Hb<90 g/l. RESULTS: Anemia (Hb<90 g/l) was associated with iron deficiency (low s-ferritin; AOR 3.4). The association with vitamin deficiencies were significant in unadjusted analysis (low s-folate; OR 3.1, low s-vitamin A; OR 2.6). Anemia was also associated with markers of infections (elevated s-CRP; AOR 3.5, urine nitrite positive; AOR 2.4) and hemolysis (elevated s-LD; AOR 10.1). A malaria positive blood slide was associated with anemia in unadjusted analysis (OR 2.7). An arm circumference less than 25 cm was associated with anemia (AOR 4.0). The associations with less severe anemia (Hb 90-109 g/l) were similar, but weaker. CONCLUSIONS: Anemia in pregnancy was associated with markers of infections and nutritional deficiencies. This should be taken into account in the management of anemia at antenatal clinics. SPONSORSHIP: The study was supported by the Norwegian Research Council (NFR) and the Centre for International Health, University of Bergen.

[Suspected large fetus in the last period of pregnancy--a difficult problem]. / Mistanke om stort foster i siste del av svangerskapet--et vanskelig 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.

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.

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.

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.

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.

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.

[Pre-eclampsia--a review]. / Preeklampsi--en oversikt.

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.

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.

Correlation between fetal sex and human chorionic gonadotropin in peripheral maternal blood and amniotic fluid in second and third trimester normal pregnancies.

BACKGROUND: To study the correlation between fetal sex and human chorionic gonadotropin (hCG) in maternal blood and amniotic fluid. METHOD AND MATERIAL: One hundred and thirty uncomplicated pregnancies, 82 of whom were at sixteen and 48 at thirty-five weeks of gestation. RESULTS: The hCG levels were significantly higher in maternal serum than in amniotic fluid. At 16 weeks there were no sex-related differences in the hCG levels, either in maternal blood or in amniotic fluid. At 35 weeks the hCG levels in maternal blood were significantly higher in pregnancies with female fetuses than in those carrying male fetuses (p<0.004), while in amniotic fluid the hCG levels tended to be slightly higher in the female group than in the male. In pregnancies with female fetuses the hCG levels in maternal blood were significantly higher at 35 than at 16 weeks (p<0.02), while in pregnancies with male fetuses the levels were highest at 16 weeks. For both sexes the hCG levels in amniotic fluid were significantly higher at 16 than at 35 weeks of pregnancy (p<0.001). Whereas a significant correlation between hCG levels in maternal blood and amniotic fluid was seen at 16 weeks of gestation for both sexes (p<0.01 and R value 0.45 for males and 0.41 for females), no correlation was observed at 35 weeks. CONCLUSION: This study shows a significant correlation between hCG and fetal sex at third trimester of gestation only, possibly caused by a gender factor and a shift in synthesis and/or in metabolism of hCG from the second to the third trimester.

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.

PIP: This paper reports the results of an antenatal care (ANC) baseline survey in four study sites in different parts of the world participating in the WHO ANC randomized controlled trial. The health care units surveyed are providing most of the activities, screening, laboratory tests and interventions recommended as effective based on the Cochrane Pregnancy and Childbirth Database (PCD), although some of these are not available in some clinics. Some tests and interventions that are considered ineffective according to the PCD criteria are reportedly offered. A variation is observed across sites in the availability and offer to low-risk women of vaginal exam, pelvic size assessment, dental exam, external version for breech presentation, and formal risk score classification. Moreover, there is a significant difference in the type of principal ANC provider and a great variation in the actual performance of screening and laboratory tests and interventions that should be provided to all women according to these criteria. This is partly due to the unavailability of these services in the site, or only a fraction of women attending the clinics are receiving them. The participating clinics all declared to follow the traditional Western schedule for ANC; however, three clinics are found to have a high percentage of women who begin their ANC after the first trimester of pregnancy. It is generalized that the variability and heterogeneity of ANC services offered in the four sites are annoying to the profession and cast doubts on the rationale behind routine ANC.