Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment two policies of iron prophylaxis
Phase phase 4
Sponsor National Istitute For Health and Welfare, Finland
Collaborator Academy of Finland
Start date May 2007
End date December 2007
Trial size 4326 participants
Trial identifier NCT00488579, PROFEG

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Routine group: 60 mg ferrous sulphate daily (+folic acid)
two policies of iron prophylaxis
Routine: 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).
(Active Comparator)
Hb measurement on each visit, Hb>9g/dl only folic acid, Hb<9g/dl 60-120 mg of ferrous sulphate daily (+folic acid)
two policies of iron prophylaxis
Routine: 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).

Primary Outcomes

Measure
Preterm delivery
time frame: Until birth
Low birth weight
time frame: At birth

Secondary Outcomes

Measure
perinatal mortality, complications during pregnancy and birth
time frame: pregnancy and neonatal period

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)
Principal investigator Elina Hemminki, PhD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by National Istitute For Health and Welfare, Finland.