Clinical trial NCT00488579: Routine Iron Prophylaxis During Pregnancy
Official title: Routine Iron Prophylaxis During Pregnancy - Effects on Maternal and Child Health in Maputo City and Province (Mozambique)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Keywords: iron prophylaxis
pregnancy
birth weight
prematurity
perinatal mortality
Lead sponsor: National Istitute For Health and Welfare, Finland
Sponsor class: OTHER_GOV
Collaborators: name: Academy of Finland
First posted: 2007-06-20
Enrollment: 4326
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 \>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 criteria: Inclusion Criteria:

* Pregnant women at their first prenatal visit

Exclusion Criteria:

* Women under 18 years, high obstetric risk pregnancies

Primary outcomes:
measure: Preterm delivery
timeFrame: Until birth
measure: Low birth weight
timeFrame: At birth
Secondary outcomes:
measure: perinatal mortality, complications during pregnancy and birth
timeFrame: pregnancy and neonatal period
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health
Study officials:
affiliation: THL
name: Elina Hemminki, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eduardo Mondlane University
name: Baltazar Chilundo
role: STUDY_DIRECTOR
References:
citation: Hemminki E, Nwaru BI, Salome G, Parkkali S, Abacassamo F, Augusto O, Cliff J, Regushevskaya E, Dgedge M, Sousa C, Chilundo B. Is selective prenatal iron prophylaxis better than routine prophylaxis: final results of a trial (PROFEG) in Maputo, Mozambique. BMJ Open. 2016 Jun 13;6(6):e011280. doi: 10.1136/bmjopen-2016-011280.
citation: Nwaru BI, Salome G, Abacassamo F, Augusto O, Cliff J, Sousa C, Regushevskaya E, Parkkali S, Hemminki E. Adherence in a pragmatic randomized controlled trial on prophylactic iron supplementation during pregnancy in Maputo, Mozambique. Public Health Nutr. 2015 Apr;18(6):1127-34. doi: 10.1017/S1368980014001359. Epub 2014 Jul 7.
citation: Parkkali S, Abacassamo F, Nwaru BI, Salome G, Augusto O, Regushevskaya E, Dgedge M, Sousa C, Cliff J, Chilundo B, Hemminki E. Comparison of routine prenatal iron prophylaxis and screening and treatment for anaemia: pregnancy results and preliminary birth results from a pragmatic randomised controlled trial (PROFEG) in Maputo, Mozambique. BMJ Open. 2013 Feb 8;3(2):e001948. doi: 10.1136/bmjopen-2012-001948. Print 2013.
citation: Nwaru BI, Parkkali S, Abacassamo F, Salome G, Chilundo B, Augusto O, Cliff J, Dgedge M, Regushevskaya E, Nikula M, Hemminki E. A pragmatic randomised controlled trial on routine iron prophylaxis during pregnancy in Maputo, Mozambique (PROFEG): rationale, design, and success. Matern Child Nutr. 2015 Apr;11(2):146-63. doi: 10.1111/mcn.12006. Epub 2012 Oct 1.