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Completed

NCT Number: NCT00488579

Routine Iron Prophylaxis During Pregnancy

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.

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Key information

Conditions

Pregnancy Birth Weight Body Weight Death Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health

Maputo, Mozambique

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women at their first prenatal visit

Exclusion criteria

  • Women under 18 years, high obstetric risk pregnancies

Treatment and study plan

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).

Primary outcomes

  1. Preterm delivery

    Time frame: Until birth

    Birth <37 gestational weeks

  2. Low birth weight

    Time frame: At birth

    weight <2500g

Secondary outcomes

  1. perinatal mortality, complications during pregnancy and birth

    Time frame: pregnancy and neonatal period

Sponsors and collaborators

Lead sponsor

National Istitute For Health and Welfare, Finland

Other Gov

Collaborators

  • Academy of Finland

Registry information

Official study title

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

Acronym: PROFEG

Important dates

Study start
2007
Primary completion
2007
Study completion
2016
First posted
Jun 20, 2007
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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