Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488579
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2007-06-19
Brief Title:
Routine Iron Prophylaxis During Pregnancy
Sponsor:
National Istitute For Health and Welfare Finland
Organization:
National Istitute For Health and Welfare Finland
Study Overview
Official Title:
Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province Mozambique
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFEG
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
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 9gdl Þ only folic acid Hb 9gdl Þ 60120 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
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 9gdl Þ only folic acid Hb 9gdl Þ 60120 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None