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Routine Iron Prophylaxis During Pregnancy (PROFEG)
This study is currently recruiting participants.
Verified by National Research and Development Centre for Welfare and Health, June 2007
Sponsored by: National Research and Development Centre for Welfare and Health
Information provided by: National Research and Development Centre for Welfare and Health
ClinicalTrials.gov Identifier: NCT00488579
  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
Anemia During Pregnancy
Procedure: Two policies of iron prophylaxis

MedlinePlus related topics: Malaria
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)

Further study details as provided by National Research and Development Centre for Welfare and Health:

Primary Outcome Measures:
  • Preterm delivery, low birth weight, malaria reactivation during pregnancy (mother) [ Time Frame: Until birth ]
  • Preterm delivery , low birth weight, malaria reactivation during pregnancy (mother) [ Time Frame: Until birth ]

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

Estimated Enrollment: 4000
Study Start Date: May 2007
Estimated Study Completion Date: December 2009
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

Study groups:

Routine group: Hb measurement on first visit, 60 mg per day of ferrous, sulphate (combination with folic acid).

Screening and therapy: Hb measurement on each visit, Hb >9g/dl Þ only folic acid, Hb <9g/dl Þ 60/120 mg per day of ferrous sulphate (+ folic acid)

Methods:

A pragmatic randomised controlled trial with non-blind design. Total intended sample size is 4000 women. Hypothesis: group 2 will have better health outcomes. Study site: Mozambique, Maputo City. Women are randomised individually and allocated into two different policy groups; 1) Routine iron prophylaxis, 2) Screening and therapy for anemia.

The recruitment of pregnant women will be 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 on their first prenatal visit

Exclusion Criteria:

  • Women under 18 years, high obstetric risk pregnancies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488579

Contacts
Contact: Saara Parkkali +358-9-39672269 saara.parkkali@stakes.fi

Locations
Mozambique
Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health Recruiting
Maputo, Mozambique
Contact: Baltazar Chilundo, MD, PhD     +258 84 3158350     chilubal@yahoo.com    
Contact: Saara Parkkali     +358-9-39672269     saara.parkkali@stakes.fi    
Sub-Investigator: Fatima Abacassamo, MD, MPH            
Sub-Investigator: Graca Salome, MD            
Sub-Investigator: Julie Cliff, MD, Prof.            
Sub-Investigator: Martinho Dgedge, MD, MSc, PhD            
Sub-Investigator: Ana Dai, MD, MPH            
Sponsors and Collaborators
National Research and Development Centre for Welfare and Health
Investigators
Principal Investigator: Elina Hemminki, PhD, MD National Research and Development Centre for Welfare and Health
Study Director: Baltazar Chilundo Universidade Eduardo Mondlane
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: PROFEG
Study First Received: June 19, 2007
Last Updated: October 31, 2007
ClinicalTrials.gov Identifier: NCT00488579  
Health Authority: Mozambique: University of Eduardo Mondlane, Ministry of Health

Keywords provided by National Research and Development Centre for Welfare and Health:
iron prophylaxis
pregnancy
birth weight
prematurity
perinatal mortality

Study placed in the following topic categories:
Body Weight
Birth Weight
Anemia
Iron

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

ClinicalTrials.gov processed this record on January 16, 2009