Routine Iron Prophylaxis During Pregnancy (PROFEG)

National Istitute For Health and Welfare, Finland

Status and phase: Completed; Phase 4

Conditions: Pregnancy

Treatments: Drug: Two policies of iron prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT00488579

PROFEG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,326 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women at their first prenatal visit

Exclusion criteria

• Women under 18 years, high obstetric risk pregnancies

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,326 participants in 2 patient groups

routine iron prophylaxis

Active Comparator group

Description:

giving 60 mg ferrous sulphate daily (+folic acid)

Treatment:

Drug: Two policies of iron prophylaxis

screening and therapy

Active Comparator group

Description:

doing Hb measurement on each visit, Hb\>9g/dl giving only folic acid, Hb\<9g/dl giving 60-120 mg of ferrous sulphate daily (+folic acid)

Treatment:

Drug: Two policies of iron prophylaxis