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.

Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was <30 days, 16% had >89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects.

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.

How do prostitution customers value health and position health in their discussions? Qualitative analysis of online forums.

AIM: Information on the health values and positioning of health among prostitution customers is limited. The aim is to explore the positioning of health among prostitution customers using data from Internet forums in Finland. METHODS: Qualitative study using a purposive sample of public online forums among prostitution customers in 2002-2012. RESULTS: Health beliefs in relation to infections and risky sexual behavior were diverse, from correct to false. Although men were aware of health risks in prostitution, it was common to have multiple sexual partners and unprotected sex. Although there were men who warned others about possible health consequences when a condom is not used, typically men were proud not to use a condom with a prostitute and found different explanations for not using a condom. Condom breakage was not an issue discussed in forums. Unexpected findings were beliefs that one fifth of the Nordic population is resistant to HIV, that the possibility of HIV transmission is exaggerated by medical specialists, and that men should control their behavior in order not to degrade prostitutes. Discussions on health service use were few. CONCLUSIONS: Sexual satisfaction and entertainment were the main reasons to post in the analyzed forums health discussion was not common although condom use was reported, attention to health risks was selective information on health service use was limited, which may suggest this topic was not valued among men and should be a topic of future studies.

Socioeconomic differences in self-rated health among women: a comparison of St. Petersburg to Estonia and Finland.

INTRODUCTION: Social determinants of health have not been intensively studied in Russia, even though the health divide has been clearly demonstrated by an increased mortality rate among those with low education. A comparative analysis of social health determinants in countries with different historical and economic backgrounds may provide useful evidence for addressing health inequalities. We aimed to assess socioeconomic determinants of self-rated health in St. Petersburg as compared to Estonia and Finland. METHODS: Data for women aged 18-44 were extracted from existing population-based surveys and analysed. In St. Petersburg the data were originally collected in 2003 (response rate 68%), in Estonia in 2004-2005 (54%), and in Finland in 2000-2001 (86%). The study samples comprised 865 women in St. Petersburg, 2141 in Estonia and 1897 in Finland. RESULTS: Self-rated health was much poorer in St. Petersburg than in Estonia or Finland. High education was negatively associated with poor self-rated health in all the studied populations; it was (partially) mediated via health behaviour and limiting long-term illness only in Estonia and Finland, but not in St. Petersburg. High personal income and employment did not associate with poor self-rated health among St. Petersburg women, as it did in Estonia and Finland. In St. Petersburg housewives rather than employed women had better self-rated health, unlike the two other areas. CONCLUSION: Women's self-rated health in St. Petersburg varied similarly by education but differently by income and employment as compared to Estonia and Finland. Education is likely the most meaningful dimension of women's socioeconomic position in St. Petersburg. More research is needed to further clarify the pathways between socioeconomic position and health in Russia.

Sociodemographic characteristics and attitudes of men buying sex in Finland.

AIM: To study the sociodemographic characteristics and attitudes associated with buying sex among Finnish men residing in different areas of Finland. METHODS: A population-based questionnaire survey among 18-74-year-old Finns in 1999 with a response rate among men of 38%. The data on 575 men were analysed with descriptive statistics and logistic regression. RESULTS: The overall proportion of men ever having bought sex was 14%. Men who at the time of the survey were in the age group 30-39, aged 50 or over, with 13-15 years of educational study, entrepreneurs, and with high income, were more likely to have ever bought sex. Being married and living with a partner at the time of the study lowered the odds of ever having bought sex. The differences between the groups were mostly the same in all residential areas, though the strength and statistical significance varied. The exception was the association with education, which occurred only in small towns. The effect of attitudes to buying sex was strong and did not differ by area of residence. CONCLUSIONS: Many men with different sociodemographic characteristics reported having bought sex. There was no noticeable variation in the sociodemographic characteristics and attitudes of men having bought sex by the area of residence. More current research is needed on the motives and health consciousness of men buying sex.

Clinical research in Finland in 2002 and 2007: quantity and type.

BACKGROUND: Regardless of worries over clinical research and various initiatives to overcome problems, few quantitative data on the numbers and type of clinical research exist. This article aims to describe the volume and type of clinical research in 2002 and 2007 in Finland. METHODS: The research law in Finland requires all medical research to be submitted to regional ethics committees (RECs). Data from all new projects in 2002 and 2007 were collected from REC files and the characteristics of clinical projects (76% of all submissions) were analyzed. RESULTS: The number of clinical projects was large, but declining: 794 in 2002 and 762 in 2007. Drug research (mainly trials) represented 29% and 34% of the clinical projects; their total number had not declined, but those without a commercial sponsor had. The number of different principal investigators was large (630 and 581). Most projects were observational, while an experimental design was used in 43% of projects. Multi-center studies were common. In half of the projects, the main funder was health care or was done as unpaid work; 31% had industry funding as the main source. There was a clear difference in the type of research by sponsorship. Industry-funded research was largely drug research, international multi-center studies, with randomized controlled or other experimental design. The findings for the two years were similar, but a university hospital as the main research site became less common between 2002 and 2007. CONCLUSIONS: Clinical research projects were common, but numbers are declining; research was largely funded by health care, with many physicians involved. Drug trials were a minority, even though most research promotion efforts and regulation concerns them.

Comparison of routine prenatal iron prophylaxis and screening and treatment for anaemia: pregnancy results and preliminary birth results from a pragmatic randomised controlled trial (PROFEG) in Maputo, Mozambique.

OBJECTIVE: To present the pregnancy results and interim birth results of a pragmatic randomised controlled trial comparing routine iron prophylaxis with screening and treatment for anaemia during pregnancy in a setting of endemic malaria and HIV. DESIGN: A pragmatic randomised controlled trial. SETTING: Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV. PARTICIPANTS: Pregnant women (≥18-year-olds; non-high-risk pregnancy, n=4326) attending prenatal care consultation at the two health centres were recruited to the trial. INTERVENTIONS: The women were randomly allocated to either Routine iron (n=2184; 60 mg ferrous sulfate plus 400 µg of folic acid daily throughout pregnancy) or Selective iron (n=2142; screening and treatment for anaemia and daily intake of 1 mg of folic acid). OUTCOME MEASURES: The primary outcomes were preterm delivery (delivery <37 weeks of gestation) and low birth weight (<2500 g). The secondary outcomes were symptoms suggestive of malaria and self-reported malaria during pregnancy; birth length; caesarean section; maternal and child health status after delivery. RESULTS: The number of follow-up visits was similar in the two groups. Between the first and fifth visits, the two groups were similar regarding the occurrence of fever, headache, cold/chills, nausea/vomiting and body aches. There was a suggestion of increased incidence of self-reported malaria during pregnancy (OR 1.37, 95% CI 0.98 to1.92) in the Routine iron group. Birth data were available for 1109 (51%) in the Routine iron group and for 1149 (54%) in the Selective iron group. The birth outcomes were relatively similar in the two groups. However, there was a suggestion (statistically non-significant) of poorer outcomes in the Routine iron group with regard to long hospital stay after birth (relative risk (RR) 1.43, 95% CI 0.97 to 1.26; risk difference (RD) 0.02, 95% CI -0.00 to 0.03) and unavailability of delivery data (RR 1.06, 95% CI 1.00 to 1.13; RD 0.03, 95% CI -0.01 to 0.07). CONCLUSIONS: These interim results suggest that routine iron prophylaxis during pregnancy did not confer advantage over screening and treatment for anaemia regarding maternal and child health. Complete data on birth outcomes are being collected for firmer conclusions. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, number NCT00488579 (June 2007). The first women were randomised to the trial proper April 2007-March 2008. The pilot was November 2006-March 2008. The 3-month lag was due to technical difficulties in completing trial registration.

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.

Variability of bothersome menopausal symptoms over time--a longitudinal analysis using the Estonian postmenopausal hormone therapy trial (EPHT).

BACKGROUND: Very little data are available on the natural course or level of disturbance of vasomotor symptoms among middle-aged women. Using readily collected trial data we studied the persistence of vasomotor symptoms among untreated women. METHODS: In a trial comparing combined hormone therapy to placebo or no treatment (control groups), a cohort of women aged 50-59 at recruitment were followed annually by questionnaires. Women in the control groups (n = 486) were grouped by the number of years followed, with the prevalence and severity of symptoms calculated both cross-sectionally and longitudinally. RESULTS: About two thirds of the women (67%) reported vasomotor symptoms and half (46%) bothersome symptoms at recruitment. In the cross-sectional analysis, their prevalence declined between recruitment and 1-year follow-up (32% bothersome symptoms) and 2-year follow-up (27%). Thereafter it remained about the same level. In the longitudinal analysis, there was a notable variation in the prevalence of disturbing vasomotor symptoms over time, time entering the study and the compliance to the surveys. In the two groups having most follow-up times, the proportion of women with bothersome symptoms first increased and then decreased. CONCLUSIONS: There was a notable variability in the development of disturbing vasomotor symptoms over time in a selected group of women aged 50-59. Population-based follow-up studies of untreated women would be useful to estimate the symptom burden.

Is HIV testing normal or special? Opinions of health professionals in four European countries in 2008.

The special norms in testing for HIV infection are not typical of testing or screening for other diseases. In four European countries, we studied health professionals' views on HIV testing This study is based on cross-sectional surveys of two groups of health professionals: presidents of selected health professional societies and head physicians and nurses of selected hospital clinics in Belgium, Estonia, Finland, and Portugal in 2008. A common structured semi-anonymous questionnaire was used in the four countries. The number of societies responding varied from five to 10 and for hospital clinics from six to 18; the response rates were from 32% to 100% and 41% to 100%, respectively. Opinions on whether HIV testing is like any other test and on the value of specific approaches in HIV testing varied both within and between countries. Some professionals thought that HIV testing is different from the testing of other infectious diseases; others thought that such an exceptional approach may be a disservice to people and to the health system. Many professionals thought that HIV testing should not be thought of only from the point of view of the individual to be tested, but also from that of other people (potential patients). Obligatory testing was considered appropriate in certain circumstances. Generally, more HIV testing in health care was called for. Normalization of HIV testing, i.e., considering it like any other diagnostic test, is unlikely to meet much opposition from health professionals. Larger surveys are needed to confirm the results.

Unauthorised pregnancies and use of maternity care in rural China.

OBJECTIVES: To describe the use of maternity care in rural China by the legal status of the pregnancy. METHODS: Cross-sectional survey wherein information was obtained about 2576 women who gave birth in 2006. Logistic regression was used to compare women having an unauthorised pregnancy with those having an authorised second birth, adjusting for confounding factors. RESULTS: Almost all respondents had antenatal care and most deliveries occurred in hospitals. Women with unauthorised pregnancies were significantly less likely to have had maternity care, particularly prenatal care, postnatal care, to have been hospitalised during pregnancy, and to have been reimbursed for hospital delivery costs than women with an authorised second birth. They were also more likely to have been hospitalised for seven or more days after delivery. Primiparous women used maternity care services and received financial support more often than women with an authorised second birth. Among the women with an unauthorised pregnancy an important reason for not using hospital care during pregnancy or delivery was financial constraint. CONCLUSIONS: Women with unauthorised pregnancies use less maternity care, although pregnancy in such circumstances may adversely impact their health. Primiparous women benefit from more financial support than multiparous women.

The determinants of sexually transmitted infections among reproductive age women in St. Petersburg, Estonia and Finland.

OBJECTIVES: Sexually transmitted infections' (STIs) rate vary in St. Petersburg, Estonia and Finland; the aim was to compare the determinants of self-reported sexually transmitted infections in these areas. METHODS: Data from four population-based questionnaire surveys were used (Finland in 1992 and 1999; St. Petersburg in 2003; Estonia in 2004). With the exception of the 1992 Finnish survey (interview) all were postal surveys, with 1,070 respondents in Finland (78 and 52% response rates), 1,147 (68%) in St. Petersburg, and 5,190 (54%) in Estonia. RESULTS: Risky sexual behaviours were equally common in the three areas and the determinants were the same. Women with an STIs history more often had had their first sexual intercourse when aged under 18, had not used condom during first intercourse, had a high number of lifetime or previous year sexual partners. However, marital status and education were not similar determinants. Cohabiting and well-educated women in Finland were more likely to have STIs while in other areas the associations found were not statistically significant. CONCLUSIONS: Risky behaviour predicts STIs, but does not explain the varying rates of STIs between areas.

Risk factors for induced abortions in St Petersburg, Estonia and Finland. Results from surveys among women of reproductive age.

OBJECTIVES: To compare the risk factors of self-reported abortion in St Petersburg, Estonia and Finland, which are neighbouring areas having different abortion rates. METHODS: Data from four population-based questionnaire surveys (Finland 1992 and 1999; St Petersburg 2003; Estonia 2004) were used. With the exception of the 1992 Finnish survey (based on interviews) all were postal surveys. There were 1070 respondents in Finland (78% and 52% response rates), 1147 (68%) in St Petersburg, and 5190 (54%) in Estonia. RESULTS: The prevalence of self-reported abortions was highest among women in St Petersburg and among the two oldest age groups of Russian-speaking Estonians. In all areas women with a history of abortion were more likely to have low education, children, a history of multiple partners and to have had their first intercourse when younger than 18 years. Insufficient use of reliable contraception, both at first and last intercourse, was the only risk factor that was more common in St Petersburg and in Estonia than in Finland. In Estonia, more Estonian than Russian-speaking women used reliable contraceptives. CONCLUSION: The comparison of three areas suggests that high abortion rates are related to low contraceptive use and not to other risky sexual behaviour.

Contraceptive use and abortion among women of reproductive age in st. Petersburg, Russia.

CONTEXT: Although the characteristics associated with contraceptive use among Russian women have been studied, no large-scale research has been conducted on women's use of different contraceptive methods and abortion. METHODS: A random sample of 1,147 women aged 18-44 completed questionnaires at local women's clinics in St. Petersburg in 2003-2004. Chi-square tests were used to examine differences in selected characteristics among age-groups, and logistic regression was used to assess associations between these characteristics and the use of contraceptive methods at last intercourse and abortion history. RESULTS: Among women at risk of unintended pregnancy, six in 10 had used reliable contraceptives (the pill, the IUD or condoms) at last intercourse; 42% had used condoms. Women in the middle income level were more likely than women with lower income to have used the pill (odds ratio, 2.1); cohabiting women and those who had had children had lowered odds of using condoms (0.6 and 0.3-0.5, respectively). More than half of those surveyed reported having had an abortion. Characteristics associated with increased odds of having had an abortion included being 25 or older (2.2-3.5), cohabiting (2.9), having high income (1.7), having experienced first intercourse before turning 18 (2.2) and having used no contraceptive method at first sex (1.5). The factor that was most strongly associated with abortion was a woman's number of births (4.9-5.7). CONCLUSIONS: Educational programs that promote the consistent use of condoms, especially among young women, and family planning programs that reduce financial barriers to contraceptive use, are critically needed in Russia.