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Routine Iron Prophylaxis During Pregnancy (PROFEG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by National Istitute For Health and Welfare, Finland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Elina Hemminki, National Istitute For Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00488579
First received: June 19, 2007
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Pregnancy
Drug: Two policies of iron prophylaxis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Istitute For Health and Welfare, Finland:

Primary Outcome Measures:
  • Preterm delivery [ Time Frame: Until birth ] [ Designated as safety issue: No ]
    Birth <37 gestational weeks

  • Low birth weight [ Time Frame: At birth ] [ Designated as safety issue: No ]
    weight <2500g


Secondary Outcome Measures:
  • perinatal mortality, complications during pregnancy and birth [ Time Frame: pregnancy and neonatal period ] [ Designated as safety issue: No ]

Estimated Enrollment: 4326
Study Start Date: May 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: routine iron prophylaxis
Routine group: 60 mg ferrous sulphate daily (+folic acid)
Drug: 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: screening and therapy
Hb measurement on each visit, Hb>9g/dl only folic acid, Hb<9g/dl 60-120 mg of ferrous sulphate daily (+folic acid)
Drug: 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: June 19, 2007
Last Updated: May 16, 2012
Health Authority: Mozambique: Ministry of Health (MISAU)

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

Additional relevant MeSH terms:
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014