Routine Iron Prophylaxis During Pregnancy
This trial is active, not recruiting.
|Treatment||two policies of iron prophylaxis|
|Sponsor||National Istitute For Health and Welfare, Finland|
|Collaborator||Academy of Finland|
|Start date||May 2007|
|End date||December 2007|
|Trial size||4326 participants|
|Trial identifier||NCT00488579, PROFEG|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||health services research|
time frame: Until birth
Low birth weight
time frame: At birth
perinatal mortality, complications during pregnancy and birth
time frame: pregnancy and neonatal period
Female participants at least 18 years old.
Inclusion Criteria: - Pregnant women at their first prenatal visit Exclusion Criteria: - Women under 18 years, high obstetric risk pregnancies
|Official title||Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)|
|Principal investigator||Elina Hemminki, PhD, MD|
|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.|
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