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Sponsored by: |
National Research and Development Centre for Welfare and Health |
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Information provided by: | National Research and Development Centre for Welfare and Health |
ClinicalTrials.gov Identifier: | NCT00488579 |
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.
Condition | Intervention |
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Anemia During Pregnancy |
Procedure: Two policies of iron prophylaxis |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique) |
Estimated Enrollment: | 4000 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
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:
Study groups:
Routine group: Hb measurement on first visit, 60 mg per day of ferrous, sulphate (combination with folic acid).
Screening and therapy: Hb measurement on each visit, Hb >9g/dl Þ only folic acid, Hb <9g/dl Þ 60/120 mg per day of ferrous sulphate (+ folic acid)
Methods:
A pragmatic randomised controlled trial with non-blind design. Total intended sample size is 4000 women. Hypothesis: group 2 will have better health outcomes. Study site: Mozambique, Maputo City. Women are randomised individually and allocated into two different policy groups; 1) Routine iron prophylaxis, 2) Screening and therapy for anemia.
The recruitment of pregnant women will be done in two health centres, one in Maputo city and one in Maputo Province. The women are followed in prenatal visits and until delivery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Saara Parkkali | +358-9-39672269 | saara.parkkali@stakes.fi |
Mozambique | |
Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health | Recruiting |
Maputo, Mozambique | |
Contact: Baltazar Chilundo, MD, PhD +258 84 3158350 chilubal@yahoo.com | |
Contact: Saara Parkkali +358-9-39672269 saara.parkkali@stakes.fi | |
Sub-Investigator: Fatima Abacassamo, MD, MPH | |
Sub-Investigator: Graca Salome, MD | |
Sub-Investigator: Julie Cliff, MD, Prof. | |
Sub-Investigator: Martinho Dgedge, MD, MSc, PhD | |
Sub-Investigator: Ana Dai, MD, MPH |
Principal Investigator: | Elina Hemminki, PhD, MD | National Research and Development Centre for Welfare and Health |
Study Director: | Baltazar Chilundo | Universidade Eduardo Mondlane |
Study ID Numbers: | PROFEG |
Study First Received: | June 19, 2007 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00488579 |
Health Authority: | Mozambique: University of Eduardo Mondlane, Ministry of Health |
iron prophylaxis pregnancy birth weight prematurity perinatal mortality |
Body Weight Birth Weight Anemia Iron |
Growth Substances Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |