Is selective prenatal iron prophylaxis better than routine prophylaxis: final results of a trial (PROFEG) in Maputo, Mozambique.

OBJECTIVE: To compare routine versus selective (ie, screening and treatment for anaemia) prenatal iron prophylaxis in a malaria-endemic and HIV-prevalent setting, an extended analysis including previously missing data. DESIGN: A pragmatic randomised controlled clinical trial. SETTING: 2 health centres in Maputo, Mozambique. PARTICIPANTS: Pregnant women (≥18 years old; non-high-risk pregnancy) were randomly allocated to routine iron (n=2184) and selective iron (n=2142) groups. INTERVENTIONS: In the routine group, women received 60 mg ferrous sulfate plus 400 µg folic acid daily. In the selective group, women received 1 mg of folic acid daily and haemoglobin (Hb) screening at each visit; with low Hb (cut-off 9 g/dL) treatment (120 mg+800 µg of folic acid daily) for a month. PRIMARY OUTCOMES: preterm birth, low birth weight; secondary outcomes: self-reported malaria, labour complications, caesarean section, perinatal death, woman's death. Nurses collected pregnancy data. Birth data were abstracted from hospital records for 52% of women and traced using various methods and linked with probabilistic matching for 24%. Women's deaths were collected from death registers. RESULTS: Birth data were available for 3301 (76%) of the women. Outcomes were similar in the two groups: preterm births (27.1% in the selective vs 25.3% in the routine group), low birthweight infants (11.0% vs 11.7%), perinatal deaths (2.4% vs 2.4%) and caesarean sections (4.0% vs 4.5%). Women's deaths during pregnancy or <42 days postpartum were more common in the selective group (0.8% among the two best matched women) than in the routine group (0.4%). Extra deaths could not be explained by the cause of death, Hb level or HIV status at recruitment. CONCLUSIONS: Birth outcomes were similar in the two iron groups. There might have been more women's deaths in the selective iron group, but it is unclear whether this was due to the intervention, other factors or chance finding. TRIAL REGISTRATION NUMBER: NCT00488579.

Supplemental iron intake and the risk of glucose intolerance in pregnancy: re-analysis of a randomised controlled trial in Finland.

Observational studies suggest that high iron intake during pregnancy is associated with the risk of gestational diabetes. As such studies are prone to bias, we re-analysed data from a randomised controlled trial of iron supplementation to see whether it supports the risk found in observational studies. The trial was conducted in primary health care setting in five municipalities in Finland in 1985-1986. The participants were 2944 women (95% of pregnant women in the area) who were randomly allocated either to (1) the selective iron group (elemental iron 50 mg twice a day only if diagnosed as anaemic, continuing until their haemoglobin increased to 110 g L(-1)) or (2) the routine iron group (elemental iron 100 mg day(-1) throughout the pregnancy regardless of haemoglobin level). The numbers of women in the analyses were 1358 and 1336, respectively. The main outcome measure was a composite variable including any glucose intolerance-related outcome (e.g. glucosuria, gestational diabetes, large-for-gestational-age child) in mothers' or children's patient records during pregnancy and post-partum. There were no statistically significant differences in the incidence of the primary outcome between the selective iron and the routine iron groups (13.0 vs. 11.0%, P = 0.12). The most common outcome was large-for-gestational-age calculated from children's hospital data (8.3 vs. 8.2%, P = 0.95). The results were mainly similar when stratified by the mothers' baseline haemoglobin level, body mass index or gestational weight gain. Routine iron supplementation throughout pregnancy did not increase the risk of glucose intolerance during pregnancy. The results need to be confirmed in future trials.

A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success.

The effects of prophylactic iron during pregnancy on maternal and child health in developing settings with endemic malaria and high prevalence of HIV remain unclear. This paper describes the rationale, implementation and success of a pragmatic randomised controlled trial comparing routine iron supplementation vs. screening and treatment for anaemia during pregnancy. The setting was two health centres in Maputo, Mozambique. Pregnant women (≥ 12-week gestation; ≥ 18 years old; and not with a high-risk pregnancy, n=4326) were recruited. The main outcomes are preterm delivery and low birthweight. The women were randomly assigned to one of two iron administration policies: a routine iron group (n=2184) received 60 mg of ferrous sulphate plus 400 µg of folic acid daily while a selective iron group (n=2142) had screening and treatment for anaemia and a daily intake of 1 mg of folic acid. The recruitment, follow-up, and collection of follow-up data were successful; both groups were similar to each other in all the trial stages. Collection of delivery data was challenging and data on about 40% of births is missing. These are currently being traced through different hospitals and health centres. The compliance of the study personnel and the women with regard to regular measurement of haemoglobin and intake of the iron and folic acid tablets was high and similar in both trial arms. Taking into account the various constraints encountered, the stages of the present trial prior to delivery were carried out well.

Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique.

OBJECTIVE: Assessing the level of adherence and its determinants is important in appraising the overall effectiveness of trials. The present study aimed to evaluate the extent of adherence and its determinants in a pragmatic randomized controlled trial of Fe prophylaxis during pregnancy in Maputo, Mozambique. DESIGN: A pragmatic randomized controlled trial. SETTING: Two health centres (1° de Maio and Machava) in Maputo, Mozambique. SUBJECTS: Pregnant women (≥12 weeks' gestation, ≥18 years old, non-high-risk pregnancy; n 4326) attending prenatal care consultations at two health centres were randomized to receive routine Fe (n 2184; 60 mg ferrous sulfate plus 400 µg folic acid daily throughout pregnancy) or selective Fe (n 2142; screening and treatment for anaemia and daily intake of 1 mg folic acid). RESULTS: The level of adherence was 79% for having two or more visits, 53% for adequate prenatal care and 67% for complete intake of Fe/folic acid tablets during the trial. The correlation between the adherence measures ranged between 0·151 and 0·739. Adherence did not differ by trial arm, but there were centre differences in adequate prenatal visits and intake of tablets. Older women (>20 years) and those with a history of abortion were more likely to achieve greater adherence, whereas an increased number of previous births decreased the likelihood of adherence. HIV positivity decreased the likelihood of adherence in one trial centre and increased it in the other. CONCLUSIONS: The variation in adherence by trial centre, women's characteristics and outcome measures suggests that adherence in trials fully depends on participants' behaviour and can be increased by paying attention to contextual factors.

Impact of financial and educational interventions on maternity care: results of cluster randomized trials in rural China, CHIMACA.

To report on the design and basic outcomes of three interventions aimed at improving the use and quality of maternity care in rural China: financial interventions, training in clinical skills, and training in health education. Community-based cluster randomized trials were carried out in one central and two western provinces between 2007 and 2009: (1) financial interventions covered part of women's costs for prenatal and postnatal care, (2) training of midwives in clinical skills was given by local maternity care experts in two- or three-group training courses, (3) health education training for midwives and village doctors were given by local experts in health education in two- or three-group training courses. A survey was conducted in a stratified random sample of women who had been pregnant in the study period. 73% of women (n = 3,673) were interviewed within 1-10 months of giving birth. Outcomes were compared by the different intervention and control groups. Adjusted odds ratios were calculated by logistic regression to adjust for varying maternal characteristics. Most of the differences found between the groups were small and some varied between provinces. The financial intervention did not influence the number of visits, but was associated with increased caesarean sections and a decrease in many ultrasound tests. The clinical intervention influenced some indicators of care content. There was no consistent finding for the health education intervention. Financial and training interventions have the potential to improve maternity care, but better implementation is required. Unintended consequences, including overuse of technology, are possible.

Evaluation of a community-based randomized controlled prenatal care trial in rural China.

BACKGROUND: A community-based randomized control prenatal care trial was performed in a rural county of China during 2000-2003. The purpose of this paper is to describe the trial implementation and the impact of the trial on the utilization of prenatal care and perinatal outcomes. MATERIALS AND METHODS: In the study county, 10 townships (from a total of 55) were each paired with a control (20 study townships in total), with the criteria for pairing being the township's socioeconomic development, perinatal health, and maternal care utilization and provision. One of each township pair was randomly allocated to the intervention or control groups. The trial interventions were: 1) training township hospital midwives and instructing them in how to provide systematic maternal care, 2) informing women in the community of the importance of prenatal care, 3) if needed, providing basic medical instruments to the hospitals. A variety of data sources were used to describe the trial implementation (observations, group discussions, field notes, survey to women). The data on pregnancy and perinatal outcomes were from the original hand-written work-records in the village family planning centers of the study townships. RESULTS: Implementation of the intervention was deficient. The factors hindering the trial implementation included poor coordination between midwives and family planning officers, broader policy changes implemented by the provincial government during the trial, the decentralization of county governance, and the lack of government funding for maternal care. There was only little difference in the use of maternal care, in women's opinions related to maternal care or content of prenatal care, and no difference in the perinatal outcomes between the intervention and control townships. CONCLUSIONS: A community based randomized controlled trial could not be fully carried out in rural China as planned due to the changing political landscape, the complexity of the socio-economic situation and a lengthy planning stage. The study could not answer if perinatal outcomes could be improved by increased use of prenatal care. TRIAL REGISTRATION: NCT 01054235.

Utilisation, contents and costs of prenatal care under a rural health insurance (New Co-operative Medical System) in rural China: lessons from implementation.

BACKGROUND: In China, the New Co-operative Medical System (NCMS), a rural health insurance system, has expanded nationwide since 2003. This study aims to describe prenatal care use, content and costs of care in one county where prenatal care is included in the NCMS and two counties where it is not. It also explores the perceptions of stakeholders of the prenatal care benefit package in order to understand the strengths and weaknesses of the approach in the context of rural China and to draw lessons from early implementation. METHODS: This study is based on the data from a cross-sectional survey and a qualitative investigation conducted in 2009. A survey recruited women giving birth in 2008, including 544 women in RC County (which covered prenatal care) and 619, and 1071 in other two counties (which did not). The qualitative investigation in RC included focus group discussions with women giving birth before or after 2007, individual interviews with local policy makers and health managers, NCMS managers and obstetric doctors in township hospitals. RESULTS: There were no significant differences in prenatal care use between RC County (which covered prenatal care) and other two counties (which did not): over 70% of women started prenatal visits early and over 60% had five or more visits. In the three counties: a small proportion of women received the number of haemoglobin and urine tests recommended by the national guideline; 90% of women received more ultrasound tests than recommended; and the out-of-pocket expenditure for prenatal care consumed a high proportion of women's annual income in the low income group. In RC: only 20% of NCMS members claimed the reimbursement; the qualitative study found that the reimbursement for prenatal care was not well understood by women and had little influence on women's decisions to make prenatal visits; and several women indicated that doctors suggested them taking more expensive tests. CONCLUSIONS: Whether or not prenatal care was included in the NCMS, prenatal care use was high, but the contents of care were not provided following the national guideline and more expensive tests were recommended by doctors. Costs were substantial for the poor.

Cesarean section rates among health professionals in Finland, 1990-2006.

OBJECTIVE. The purpose of this paper is to establish whether health professionals in Finland have cesarean sections more or less often than other women of a similar educational background. DESIGN. Register-based study (Finnish birth register). SETTING. Finland 1990-2006. POPULATION. Singleton births, for midwives (3,009 births), nurses (101,199), and physicians (7,642). Teachers (n=23,454) were chosen as controls for midwives and nurses, and other white collar workers (n=124,606) were chosen as controls for physicians. METHODS. Cesarean section rates were studied for all births and for first births only. The odds ratios for mode of delivery were calculated using logistic regression, adjusting for age, parity, marital status and smoking, and in an additional analysis, also adjusting for post-term birth and birth weight. MAIN OUTCOME MEASURES. Mode of delivery. RESULTS. During the time period studied, the overall cesarean section rate in Finland was 15%. The studied groups had similar rates of cesarean section. When adjusting for background characteristics, midwives and nurses had marginally lower cesarean section rates than teachers, and physicians had lower rates than other white collar workers. In the case of first births, similar differences were found. Instrumental deliveries were somewhat lower among midwives as compared to teachers, and among physicians as compared to other white collar workers. CONCLUSIONS. Our results suggest that Finnish physicians may prefer vaginal delivery and have relatively conservative opinions about cesarean sections. This may be an important explanation of the relatively low, compared to international rates, and stable cesarean section rates in Finland.

Maternal care in rural China: a case study from Anhui province.

BACKGROUND: Studies on prenatal care in China have focused on the timing and frequency of prenatal care and relatively little information can be found on how maternal care has been organized and funded or on the actual content of the visits, especially in the less developed rural areas. This study explored maternal care in a rural county from Anhui province in terms of care organization, provision and utilization. METHODS: A total of 699 mothers of infants under one year of age were interviewed with structured questionnaires; the county health bureau officials and managers of township hospitals (n = 10) and county level hospitals (n = 2) were interviewed; the process of the maternal care services was observed by the researchers. In addition, statistics from the local government were used. RESULTS: The county level hospitals were well staffed and equipped and served as a referral centre for women with a high-risk pregnancy. Township hospitals had, on average, 1.7 midwives serving an average population of 15,000 people. Only 10-20% of the current costs in county level hospitals and township hospitals were funded by the local government, and women paid for delivery care. There was no systematic organized prenatal care and referrals were not mandatory. About half of the women had their first prenatal visit before the 13th gestational week, 36% had fewer than 5 prenatal visits, and about 9% had no prenatal visits. A major reason for not having prenatal care visits was that women considered it unnecessary. Most women (87%) gave birth in public health facilities, and the rest in a private clinic or at home. A total of 8% of births were delivered by caesarean section. Very few women had any postnatal visits. About half of the women received the recommended number of prenatal blood pressure and haemoglobin measurements. CONCLUSION: Delivery care was better provided than both prenatal and postnatal care in the study area. Reliance on user fees gave the hospitals an incentive to put more emphasis on revenue generating activities such as delivery care instead of prenatal and postnatal care.

Medical and lay attitudes towards genetic screening and testing in Finland.

The purpose of this study was to compare physicians', midwives' and lay people's attitudes towards genetic screening and testing to find out whether medical education and experience influence attitudes of genetic screening and testing. The study was based on comparison of answers to joint questions in three different cross-sectional postal surveys between October 1996 and April 1998 in Finland. Target groups were physicians (study base n=772, response rate 74%, including gynaecologists, paediatricians, general practitioners and clinical geneticists), midwives and public health nurses (collectively referred to as midwives in the following; n=800, response rate 79%), and lay people (n=2000, response rate 62%). Midwives were more worried about the consequences of genetic testing and stressed the autonomy of the customer more strongly than lay people did. Furthermore, professionals considered that lay peoples' expectations as regards to genetic testing are too high. Having more medical education was related to having less 'cannot say' and missing responses. Our results do not suggest that major conflicts about the direction of genetic testing and screening would arise in near future. However, different positions and interests should be considered. Reporting in public about new prospects and developments in medical genetics should pay more attention also to concerns for balancing promises and drawbacks.