Routine Iron Prophylaxis During Pregnancy

Overview

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.

Full Title of Study: “Routine Iron Prophylaxis During Pregnancy – Effects on Maternal and Child Health in Maputo City and Province (Mozambique)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2007

Detailed 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.

Interventions

  • Drug: 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).

Arms, Groups and Cohorts

  • Active Comparator: routine iron prophylaxis
    • giving 60 mg ferrous sulphate daily (+folic acid)
  • Active Comparator: 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)

Clinical Trial Outcome Measures

Primary Measures

  • Preterm delivery
    • Time Frame: Until birth
    • Birth <37 gestational weeks
  • Low birth weight
    • Time Frame: At birth
    • weight <2500g

Secondary Measures

  • perinatal mortality, complications during pregnancy and birth
    • Time Frame: pregnancy and neonatal period

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant women at their first prenatal visit Exclusion Criteria:

  • Women under 18 years, high obstetric risk pregnancies

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Istitute For Health and Welfare, Finland
  • Collaborator
    • Academy of Finland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elina Hemminki, MD, Research Professor, THL – National Istitute For Health and Welfare, Finland
  • Overall Official(s)
    • Elina Hemminki, PhD, MD, Principal Investigator, THL
    • Baltazar Chilundo, Study Director, Eduardo Mondlane University

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