Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
4326 participants
INTERVENTIONAL
2007-05-31
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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routine iron prophylaxis
giving 60 mg ferrous sulphate daily (+folic acid)
Two 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).
screening and therapy
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)
Two 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).
Interventions
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Two 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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Academy of Finland
OTHER
National Istitute For Health and Welfare, Finland
OTHER_GOV
Responsible Party
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Elina Hemminki
MD, Research Professor, THL
Principal Investigators
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Elina Hemminki, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
THL
Baltazar Chilundo
Role: STUDY_DIRECTOR
Eduardo Mondlane University
Locations
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Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health
Maputo, , Mozambique
Countries
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References
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Hemminki E, Nwaru BI, Salome G, Parkkali S, Abacassamo F, Augusto O, Cliff J, Regushevskaya E, Dgedge M, Sousa C, Chilundo B. Is selective prenatal iron prophylaxis better than routine prophylaxis: final results of a trial (PROFEG) in Maputo, Mozambique. BMJ Open. 2016 Jun 13;6(6):e011280. doi: 10.1136/bmjopen-2016-011280.
Nwaru BI, Salome G, Abacassamo F, Augusto O, Cliff J, Sousa C, Regushevskaya E, Parkkali S, Hemminki E. Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique. Public Health Nutr. 2015 Apr;18(6):1127-34. doi: 10.1017/S1368980014001359. Epub 2014 Jul 7.
Parkkali S, Abacassamo F, Nwaru BI, Salome G, Augusto O, Regushevskaya E, Dgedge M, Sousa C, Cliff J, Chilundo B, Hemminki E. Comparison of routine prenatal iron prophylaxis and screening and treatment for anaemia: pregnancy results and preliminary birth results from a pragmatic randomised controlled trial (PROFEG) in Maputo, Mozambique. BMJ Open. 2013 Feb 8;3(2):e001948. doi: 10.1136/bmjopen-2012-001948. Print 2013.
Nwaru BI, Parkkali S, Abacassamo F, Salome G, Chilundo B, Augusto O, Cliff J, Dgedge M, Regushevskaya E, Nikula M, Hemminki E. A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success. Matern Child Nutr. 2015 Apr;11(2):146-63. doi: 10.1111/mcn.12006. Epub 2012 Oct 1.
Other Identifiers
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PROFEG
Identifier Type: -
Identifier Source: org_study_id