Routine Iron Prophylaxis During Pregnancy (PROFEG)

November 29, 2017 updated by: Elina Hemminki, National Istitute For Health and Welfare, Finland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4326

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mozambique
      • Maputo, Mozambique
        • Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women at their first prenatal visit

Exclusion Criteria:

  • Women under 18 years, high obstetric risk pregnancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: routine iron prophylaxis
giving 60 mg ferrous sulphate daily (+folic acid)
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).
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)
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Istitute For Health and Welfare, Finland

Collaborators

Academy of Finland

Investigators

  • Principal Investigator: Elina Hemminki, PhD, MD, THL
  • Study Director: Baltazar Chilundo, Eduardo Mondlane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROFEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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