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Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Mamoudou Cisse, Centre Muraz
ClinicalTrials.gov Identifier:
NCT01255605
First received: December 6, 2010
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Malaria, Pregnancy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Intermittent Preventive Treatment (IPT) With Sulfadoxine-pyrimethamine (SP) on the Morbidities Associated With Malaria in Pregnant Women and Newborns in Peri-urban Areas of Bobo-Dioulasso, 5 Years After Its Adoption by the National Program for Fight Against Malaria in Burkina Faso.

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Université Polytechnique de Bobo-Dioulasso:

Primary Outcome Measures:
  • Peripheral and placental malaria [ Time Frame: Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Maternal anemia, congenital malaria,low birth weight, prematurity. [ Time Frame: Maternal anemia: at antenatal clinics and at delivery. Congenital malaria: at delivery. Low birth weight: at delivery. Prematurity: at delivery. ] [ Designated as safety issue: No ]

    The investigators will check pregnant women haemoglobin level.A level< 11g/dl will be considered as anemia.

    Congenital malaria will be assessed through cord blood smear. Birth weight <2500g will be considered as low birth weight. Prematurity designs any birth before 37 gestation weeks.



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.


Enrollment: 772
Study Start Date: September 2010
Study Completion Date: June 2011
Detailed Description:

Malaria in pregnant women is a crucial issue in Burkina Faso. Faced with this problem, a strategy based on the use of treated nets and intermittent preventive treatment (IPT) based on sulfadoxine-pyrimethamine (SP) was adopted in 2005. Five years after its implementation, the investigators will check whether this strategy is still effective in the preventing maternal and congenital malaria on the one hand and maternal anemia, low birth weight and prematurity on the other hand.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Bleeding from during the pregnancy
  • eclampsia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255605

Locations
Burkina Faso
Institut Supérieur des Sciences de la Santé/Université Polytechnique de Bobo-Dioulasso
Bobo-Dioulasso, Houet, Burkina Faso, 1091
Sponsors and Collaborators
Université Polytechnique de Bobo-Dioulasso
Investigators
Principal Investigator: Mamoudou Cisse, MD Centre MURAZ Research Institute
  More Information

No publications provided

Responsible Party: Dr Mamoudou Cisse, Medical doctor, Centre Muraz
ClinicalTrials.gov Identifier: NCT01255605     History of Changes
Other Study ID Numbers: PIC/INSSA/UPB-01
Study First Received: December 6, 2010
Last Updated: June 15, 2012
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Université Polytechnique de Bobo-Dioulasso:
Intermittent preventive treatment with sulfadoxin-pyrimethamine
in Bobo-Dioulasso peri-urban areas, 5 years after its implementation
Burkina Faso.

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013