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

ABSTRACT: 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 ?g 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.

SUBMITTER: Nwaru BI

PROVIDER: S-EPMC6860233 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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

Nwaru Bright I BI Parkkali Saara S Abacassamo Fatima F Salomé Graca G Chilundo Baltazar B Augusto Orvalho O Cliff Julie J Dgedge Martinho M Regushevskaya Elena E Nikula Minna M Hemminki Elina E

Maternal & child nutrition 20121001 2

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- ...[more]

PMID: 23020829

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Project description: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.A pragmatic randomised controlled trial.Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV.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.The women were randomly allocated to either Routine iron (n=2184; 60 mg ferrous sulfate plus 400 ?g 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).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.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).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.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.

Project description: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??g 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??g of folic acid daily) for a month. OUTCOME MEASURES: 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.

Project description:BACKGROUND:Irrational use of antibiotics is a major driver of antimicrobial resistance (AMR) worldwide. Sub-Saharan Africa, where the risk of spread of AMR is highest, lacks data on the knowledge, attitudes and practices regarding antibiotic prescription and use. This is the first study in Mozambique to address this gap. METHODS:A cross-sectional study was conducted in 2016 in 1091 adults (age ?18 years) living in five districts in peri-urban areas of Maputo City. Three stage cluster sampling was used to select the households. A semi-structured questionnaire was used to collect information on the knowledge, attitudes and practices regarding antibiotics and their use and socio-demographic data. RESULTS:Of the 1091 participants, 20.9% (228/1091) had used non-prescribed antibiotics. Most of the non-prescribed antibiotics were purchased in pharmacies (199/228; 87.3%). The proportion of use of non-prescribed antibiotics was higher in those who purchased from informal markets (82.6%; 14/17) and home stores (66.7%; 12/18), compared to pharmacies (24.6%; 199/810) (p = 0.000). Variables significantly associated with use of non-prescribed antibiotics were male gender (p = 0.004), living in the Central A (p<0.001), Aeroporto B (p<0.001) or 25 de Junho (p<0.001) neighborhoods, purchase of antibiotics in informal markets (p<0.002) or obtaining from home stores (p = 0.026), not completing the course (p<0.001) and having poor knowledge on the use of antibiotics (p<0.001). Main reasons for use of non-prescribed antibiotics were a perception that there was no need to attend a health facility (26.8%), followed by someone else's advice (7.7%), symptoms similar to a previous episode (6.2%) and poor quality of care in health facilities (6.7%). CONCLUSIONS:Our study shows for the first time that knowledge regarding antibiotics is poor in Maputo City. Purchase of non-prescribed antibiotics is a common practice and most are sold in pharmacies, indicating deficient inspection. Interventions to reinforce adherence by pharmacies to current legislation for dispensing antibiotics, combined with community education are urgently needed.

Project description:BACKGROUND:Approximately 18% of Sub-Saharan Africa's urban population relies on shared sanitation facilities, which are shared by one or more households. While there is growing recognition of sanitation's relationship with stress and well-being - particularly among women - most research has focused on rural populations and the transition from open defecation and/or unimproved latrines to private shared sanitation. This study explores sanitation-related stressors among users of both improved and unimproved shared sanitation facilities. METHODS:This study was nested within the larger MapSan health impact trial (Trial Registration: NCT02362932). Participants were recruited from the control arm of the trial (Traditional Latrine (TL) users) and intervention arm, which received one of two improved shared sanitation facilities - Shared Latrines (SL) shared by up to 20 individuals and Community Sanitation Blocks (CSBs) shared by more than 20 individuals. Sampling was informed by a life stage perspective to reflect diversity in sanitation needs and experiences within the population. Data included 96 in-depth interviews, 7 focus group discussions, and 25 unstructured observations. Data collection and analysis followed a Grounded Theory approach, which was used to identify the key domains of sanitation-related stress among participants. A semi-structured tool was applied to all female interview transcripts to assess the frequency and severity of key stressors. RESULTS:Participants reported stress due to: lack of safety; lack of privacy; disgust about the latrine condition; and collective action failure in terms of managing the latrine, often causing neighborhood conflict or unhygienic sanitation conditions. Fewer SL and CSB users reported specific stress domains and - with the exception of perceived safety - reported fewer severe stressors. The leading cause of stress reduction due to the intervention was decreased disgust followed by increased privacy and safety. CONCLUSIONS:Our data suggest that "improved", shared facilities can reduce stress when proper maintenance and management systems are in place. Private, shared sanitation only had limited impact on users' perceptions of safety, particularly at night, suggesting that safety concerns extend beyond the physical latrine structure. Our research demonstrates that factors including latrine location and neighborhood violence are important determinants of safety perceptions and corresponding psychosocial stress.

Project description:OBJECTIVES:To investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions. DESIGN:Pragmatic, multicentre, stepped wedge cluster randomised trial. SETTING:60 midwifery practices in the Netherlands. PARTICIPANTS:13 046 women aged 16 years or older with a low risk singleton pregnancy. INTERVENTIONS:60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks' gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies. MAIN OUTCOME MEASURES:The primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth. RESULTS:Between 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks' gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies. CONCLUSION:In low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies. TRIAL REGISTRATION:Netherlands Trial Register NTR4367.

Dataset Information

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

Publications

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

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