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Routine Iron Prophylaxis During Pregnancy

Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00488579
Acronym
PROFEG
Enrollment
4326
Registered
2007-06-20
Start date
2007-05-31
Completion date
2016-05-31
Last updated
2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

iron prophylaxis, pregnancy, birth weight, prematurity, perinatal mortality

Brief summary

Comparison of two policies of iron administration during pregnancy in regard to health and program feasibility in an area with endemic malaria and high prevalence of HIV infection. The policies are: 1) routine iron prophylaxis, 2) screening and therapy with iron.

Detailed description

Aim of the study: Comparison of two policies of iron administration during pregnancy in regard to health of the mother and infant and program feasibility. The two groups compared are: 1. Routine iron prophylaxis 2. Screening of anaemia and therapy with iron Hypothesis: group 2 will have better health outcomes. Study groups: Routine group: 60 mg per day of ferrous sulphate (combination with folic acid) daily. Screening and therapy: Hb measurement on each visit, Hb \>9g/dl Þ only folic acid, Hb \<9g/dl Þ 60/120 mg of ferrous sulphate daily(+ folic acid) Methods: A pragmatic randomised controlled trial with non-blind design. Total intended sample size was 4000 women. Study site: Mozambique, Maputo City. Women are randomised individually and allocated into the two groups; 1) Routine iron prophylaxis, 2) Screening and therapy for anemia. The recruitment of pregnant women was done in two health centres, one in Maputo city and one in Maputo Province. The women are followed in prenatal visits and until delivery.

Interventions

DRUGTwo policies of iron prophylaxis

60mg ferrous sulphate daily (+folic acid); Screening and therapy: Hb measurement on each visit, Hb\>9g/dl only folic acid, Hb\<9g/dl 60-120 of ferrous sulphate daily (+folic acid).

Sponsors

Academy of Finland
CollaboratorOTHER
National Istitute For Health and Welfare, Finland
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women at their first prenatal visit

Exclusion criteria

* Women under 18 years, high obstetric risk pregnancies

Design outcomes

Primary

MeasureTime frameDescription
Preterm deliveryUntil birthBirth \<37 gestational weeks
Low birth weightAt birthweight \<2500g

Secondary

MeasureTime frame
perinatal mortality, complications during pregnancy and birthpregnancy and neonatal period

Countries

Mozambique

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026