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Routine Iron Prophylaxis During Pregnancy (PROFEG)

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ClinicalTrials.gov Identifier: NCT00488579
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Elina Hemminki, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Two policies of iron prophylaxis Phase 4

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  (Clinical Trial)
Actual Enrollment : 4326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)
Study Start Date : May 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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).




Primary Outcome Measures :
  1. Preterm delivery [ Time Frame: Until birth ]
    Birth <37 gestational weeks

  2. Low birth weight [ Time Frame: At birth ]
    weight <2500g


Secondary Outcome Measures :
  1. perinatal mortality, complications during pregnancy and birth [ Time Frame: pregnancy and neonatal period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women at their first prenatal visit

Exclusion Criteria:

  • Women under 18 years, high obstetric risk pregnancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488579


Locations
Mozambique
Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health
Maputo, Mozambique
Sponsors and Collaborators
National Istitute For Health and Welfare, Finland
Academy of Finland
Investigators
Principal Investigator: Elina Hemminki, PhD, MD THL
Study Director: Baltazar Chilundo Universidade Eduardo Mondlane

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elina Hemminki, MD, Research Professor, THL, National Istitute For Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00488579     History of Changes
Other Study ID Numbers: PROFEG
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elina Hemminki, National Istitute For Health and Welfare, Finland:
iron prophylaxis
pregnancy
birth weight
prematurity
perinatal mortality

Additional relevant MeSH terms:
Iron
Folic Acid
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamin B Complex
Vitamins