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



A pragmatic randomised controlled clinical trial.



2 health centres in Maputo, Mozambique.



Pregnant women (≥18 years old; non-high-risk pregnancy) were randomly allocated to routine iron (n=2184) and selective iron (n=2142) groups.



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.







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.



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.



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.



NCT00488579.
Health Services and Policy Research, National Institute for Health and Welfare, Helsinki, Finland.
Elina
E
Hemminki
Centre for Medical Informatics, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, UK School of Health Sciences, University of Tampere, Tampere, Finland.
Bright I
BI
Nwaru
Medical Faculty, Department of Physiological Sciences, Eduardo Mondlane University, Maputo, Mozambique.
Graca
G
Salomé
Health Services and Policy Research, National Institute for Health and Welfare, Helsinki, Finland.
Saara
S
Parkkali
Medical Faculty, Department of Community Health, Eduardo Mondlane University, Maputo, Mozambique.
Fatima
F
Abacassamo
Medical Faculty, Department of Community Health, Eduardo Mondlane University, Maputo, Mozambique.
Orvalho
O
Augusto
Medical Faculty, Department of Community Health, Eduardo Mondlane University, Maputo, Mozambique.
Julie
J
Cliff
Health Services and Policy Research, National Institute for Health and Welfare, Helsinki, Finland.
Elena
E
Regushevskaya
Ministry of Health, Maputo, Mozambique.
Martinho
M
Dgedge
Medical Faculty, Department of Community Health, Eduardo Mondlane University, Maputo, Mozambique.
Cesar
C
Sousa
Medical Faculty, Department of Community Health, Eduardo Mondlane University, Maputo, Mozambique.
Baltazar
B
Chilundo
D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000517:prevention & control; D002585:Cesarean Section / Q000706:statistics & numerical data*; D019587:Dietary Supplements; D005260:Female; D005296:Ferrous Compounds / Q000008:administration & dosage*; D005492:Folic Acid / Q000008:administration & dosage*; D015658:HIV Infections / Q000150:complications; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007223:Infant; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007501:Iron / Q000008:administration & dosage; D008288:Malaria / Q000150:complications; D063130:Maternal Death / Q000706:statistics & numerical data*; D009073:Mozambique; D066087:Perinatal Death; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000517:prevention & control; D047928:Premature Birth / Q000453:epidemiology*; D011295:Prenatal Care / Q000379:methods*; D055815:Young Adult
D005296:Ferrous Compounds; D006454:Hemoglobins; C020748:ferrous sulfate; D005492:Folic Acid; D007501:Iron
birth; iron supplementation; malaria; pragmatic trial; pregnancy