Routine Iron Prophylaxis During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Routine iron prophylaxis 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.

Official Title
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Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Two policies of iron prophylaxis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women at their first prenatal visit Exclusion Criteria: Women under 18 years, high obstetric risk pregnancies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: routine iron prophylaxis<br>giving 60 mg ferrous sulphate daily (+folic acid) | Drug: Two policies of iron prophylaxis<br>* 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).<br>|
| Active Comparator: screening and therapy<br>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) | Drug: Two policies of iron prophylaxis<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery | Birth <37 gestational weeks | Until birth | 
| Low birth weight | weight <2500g | At birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perinatal mortality, complications during pregnancy and birth |  | pregnancy and neonatal period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron prophylaxis, pregnancy, birth weight, prematurity, perinatal mortality