Routine Iron Prophylaxis During Pregnancy

Pregnancy Clinical Trial

— PROFEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488579
• Other study ID #: PROFEG
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2007
• Last updated: November 29, 2017
• Start date: May 2007
• Est. completion date: May 2016

Study information

• Verified date: November 2017
• Source: National Istitute For Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4326
• Est. completion date: May 2016
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women at their first prenatal visit

Exclusion Criteria:

• Women under 18 years, high obstetric risk pregnancies

Related Conditions & MeSH terms

• Pregnancy

Intervention

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).

Locations

Country	Name	City	State
Mozambique	Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health	Maputo

Sponsors (2)

Lead Sponsor	Collaborator
National Istitute For Health and Welfare, Finland	Academy of Finland

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm delivery	Birth <37 gestational weeks	Until birth
Primary	Low birth weight	weight <2500g	At birth
Secondary	perinatal mortality, complications during pregnancy and birth		pregnancy and neonatal period

External Links

•   Medical technology in maternity services