NCT00488579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,326

participants targeted

Target at P75+ for phase_4 pregnancy

Timeline
Completed

Started May 2007

Longer than P75 for phase_4 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

June 19, 2007

Last Update Submit

November 29, 2017

Conditions

Pregnancy

Keywords

iron prophylaxispregnancybirth weightprematurityperinatal mortality

Outcome Measures

Primary Outcomes (2)

  • Preterm delivery

    Birth \<37 gestational weeks

    Until birth

  • Low birth weight

    weight \<2500g

    At birth

Secondary Outcomes (1)

  • perinatal mortality, complications during pregnancy and birth

    pregnancy and neonatal period

Study Arms (2)

routine iron prophylaxis

ACTIVE COMPARATOR

giving 60 mg ferrous sulphate daily (+folic acid)

Drug: Two policies of iron prophylaxis

screening and therapy

ACTIVE COMPARATOR

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)

Drug: Two policies of iron prophylaxis

Interventions

Two policies of iron prophylaxisDRUG

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).

routine iron prophylaxisscreening and therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women at their first prenatal visit

You may not qualify if:

  • Women under 18 years, high obstetric risk pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Eduardo Mondlande, Faculty of Medicine, Department of Community Health

Maputo, Mozambique

Location

Related Publications (4)

  • 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: 27297013DERIVED

  • 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: 24999785DERIVED

  • 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: 23396557DERIVED

  • 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: 23020829DERIVED

MeSH Terms

Conditions

Birth WeightPremature BirthPerinatal Death

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic Processes

Study Officials

  • Elina Hemminki, PhD, MD

    THL

    PRINCIPAL INVESTIGATOR

  • Baltazar Chilundo

    Eduardo Mondlane University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Professor, THL

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2007

Study Completion

May 1, 2016

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)