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

Abstract

ObjectiveTo 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.DesignA pragmatic randomised controlled clinical trial.Setting2 health centres in Maputo, Mozambique.ParticipantsPregnant women (≥18 years old; non-high-risk pregnancy) were randomly allocated to routine iron (n=2184) and selective iron (n=2142) groups.InterventionsIn 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.Outcome measuresPrimary 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.ResultsBirth 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.ConclusionsBirth 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 numberNCT00488579.

Maternal death and postpartum hemorrhage in sub‐Saharan Africa – A pilot study in metropolitan Mozambique

“…In our study, the maternal prevalence of HIV infection was high (17%), similar to a previously reported study performed in metropolitan Maputo . Not unexpectedly, HIV infection was associated with high maternal mortality, also reported by others for this region .…”

Causes of death among women aged 17–49 years between 2007 and 2010 in Maputo, Mozambique

“…Originally the death data were collected to complete the tracing of 4326 pregnant women recruited for a trial in Maputo [ 10 ]. In that trial, the effects of two iron administration policies (routine iron prophylaxis vs screening and treatment for anemia during pregnancy) on maternal and child health were compared.…”

“…In that trial, the effects of two iron administration policies (routine iron prophylaxis vs screening and treatment for anemia during pregnancy) on maternal and child health were compared. The results from the trial have been presented in a previous paper [ 10 ].…”

“…It has been estimated that in the whole southern region (including Maputo) the prevalence of HIV in 2010 among 15–49 year–old women was 21% [ 14 ]. In Maputo, in a cohort of pregnant women in 2006–2008 recruited into a pragmatic randomized controlled trial on iron prophylaxis in Maputo, the HIV–positivity was 20% [ 10 ].…”

“…Furthermore, we estimated overall death rates, calculated the proportion of deaths occurring in hospital, and compared the causes of deaths to those reported in a 2001 study [ 9 ]. The data are a spin–off from a trial [ 10 ], for which the outcomes of the study women were searched from various sources.…”