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Routine Iron Prophylaxis During Pregnancy — PROFEG  

Pregnancy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00488579
Study type Interventional
Source National Istitute For Health and Welfare, Finland
Contact
Status Completed
Phase Phase 4
Start date May 2007
Completion date May 2016
View Details
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