## Protocol Section
### Identification Module
**NCT ID:** NCT00488579

**Acronym:** PROFEG

**Brief Title:** Routine Iron Prophylaxis During Pregnancy

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

#### Organization Study ID Info
**ID:** PROFEG
#### Organization
**Class:** OTHER_GOV
**Full Name:** National Istitute For Health and Welfare, Finland
### Status Module
#### Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-11-30

**Type:** ACTUAL

**Last Update Submit Date:** 2017-11-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Start Date
**Date:** 2007-05

**Status Verified Date:** 2017-11

#### Study First Post Date
**Date:** 2007-06-20
**Type:** ESTIMATED
**Study First Submit Date:** 2007-06-19
**Study First Submit QC Date:** 2007-06-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Academy of Finland

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** National Istitute For Health and Welfare, Finland

#### Responsible Party

**Investigator Affiliation:** National Istitute For Health and Welfare, Finland

**Investigator Full Name:** Elina Hemminki

**Investigator Title:** MD, Research Professor, THL

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pregnancy

**Keywords:**

- iron prophylaxis

- pregnancy

- birth weight

- prematurity

- perinatal mortality

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 4326

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** giving 60 mg ferrous sulphate daily (+folic acid)

**Intervention Names:**

- Drug: Two policies of iron prophylaxis

**Label:** routine iron prophylaxis

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** doing Hb measurement on each visit, Hb\>9g/dl giving only folic acid, Hb\<9g/dl giving 60-120 mg of ferrous sulphate daily (+folic acid)

**Intervention Names:**

- Drug: Two policies of iron prophylaxis

**Label:** screening and therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- routine iron prophylaxis

- screening and therapy

**Description:** 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).

**Name:** Two policies of iron prophylaxis

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Birth \<37 gestational weeks

**Measure:** Preterm delivery

**Time Frame:** Until birth

**Description:** weight \<2500g

**Measure:** Low birth weight

**Time Frame:** At birth

#### Secondary Outcomes

**Measure:** perinatal mortality, complications during pregnancy and birth

**Time Frame:** pregnancy and neonatal period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant women at their first prenatal visit

Exclusion Criteria:

* Women under 18 years, high obstetric risk pregnancies

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Maputo

**Country:** Mozambique

**Facility:** Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health

#### Overall Officials

**Official 1:**

**Affiliation:** THL

**Name:** Elina Hemminki, PhD, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Eduardo Mondlane University

**Name:** Baltazar Chilundo

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 27297013

**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.

**PMID:** 24999785

**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.

**PMID:** 23396557

**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.

**PMID:** 23020829

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M5006

- Name: Birth Weight

- Relevance: LOW

- As Found: Unknown

- ID: M30666

- Name: Perinatal Death

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

- Abbrev: Mi

- Name: Mineral

### Intervention Browse Module - Browse Leaves

- ID: M10533

- Name: Iron

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

- ID: T341

- Name: Iron Supplement

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
