NCT01255605

Brief Summary

The purpose of this is to determine the impact of intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its implemented.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
772

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

First QC Date

December 6, 2010

Last Update Submit

June 15, 2012

Conditions

Keywords

Intermittent preventive treatment with sulfadoxin-pyrimethaminein Bobo-Dioulasso peri-urban areas, 5 years after its implementationBurkina Faso.

Outcome Measures

Primary Outcomes (1)

  • Peripheral and placental malaria

    The investigators will check if pregnant women have any malaria parasites by making a finger prick thick respectively at antenatal clinics and at delivery. A placental thin smear will be made at delivery.

    Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery

Secondary Outcomes (1)

  • Maternal anemia, congenital malaria,low birth weight, prematurity.

    Maternal anemia: at antenatal clinics and at delivery. Congenital malaria: at delivery. Low birth weight: at delivery. Prematurity: at delivery.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study population is constitued by pregnant women coming for antenatal care or delivery in two peripheral heath facilities of Bobo-Dioulasso(Lafiabougou and Secteur 24).

You may qualify if:

  • Residing in the health area of Lafiabougou or secteur 24
  • Having agreed to give free and informed consent

You may not qualify if:

  • Bleeding from during the pregnancy
  • eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Supérieur des Sciences de la Santé/Université Polytechnique de Bobo-Dioulasso

Bobo-Dioulasso, Houet, 1091, Burkina Faso

Location

Biospecimen

Retention: SAMPLES WITH DNA

The investigators make thick and thin blood smear and collect a few drops of blood on the 3MM paper Whatmann Schleicher-Schuell.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Mamoudou Cisse, MD

    Centre MURAZ Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 7, 2010

Study Start

September 1, 2010

Study Completion

June 1, 2011

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations