Routine Iron Prophylaxis During Pregnancy

Phase 4

Completed

• Conditions: Pregnancy
• Interventions: Drug: Two policies of iron prophylaxis

• Registration Number: NCT00488579
• Lead Sponsor: National Istitute For Health and Welfare, Finland

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Primary Completion: 2007-12
• Study Completion: 2016-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4326

Inclusion Criteria

• Pregnant women at their first prenatal visit

Exclusion Criteria

• Women under 18 years, high obstetric risk pregnancies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
routine iron prophylaxis	Two policies of iron prophylaxis	giving 60 mg ferrous sulphate daily (+folic acid)
screening and therapy	Two policies of iron prophylaxis	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)

Primary Outcome Measures

Name	Time	Method
Preterm delivery	Until birth	Birth \<37 gestational weeks
Low birth weight	At birth	weight \<2500g

Secondary Outcome Measures

Name	Time	Method
perinatal mortality, complications during pregnancy and birth	pregnancy and neonatal period

Trial Locations

Locations (1)

Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health; 🇲🇿 Maputo, Mozambique