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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine iron prophylaxis | Active Comparator | giving 60 mg ferrous sulphate daily (+folic acid) |
|
| screening and therapy | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two policies of iron prophylaxis | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm delivery | Birth <37 gestational weeks | Until birth |
| Low birth weight | weight <2500g | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| perinatal mortality, complications during pregnancy and birth | pregnancy and neonatal period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elina Hemminki, PhD, MD | THL | Principal Investigator |
| Baltazar Chilundo | Eduardo Mondlane University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health | Maputo | Mozambique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27297013 | Derived | 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. | |
| 24999785 |
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| ID | Term |
|---|---|
| D001724 | Birth Weight |
| D047928 | Premature Birth |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
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| 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. |
| 23396557 | Derived | 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. |
| 23020829 | Derived | 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. |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |