Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)
| Tracking Information | |||||
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| First Received Date ICMJE | December 6, 2010 | ||||
| Last Updated Date | June 15, 2012 | ||||
| Start Date ICMJE | September 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Peripheral and placental malaria [ Time Frame: At delivery ] [ Designated as safety issue: No ] The investigators will check if pregnant women have any malaria parasites at delivery by making a finger prick thick and placental thin smear |
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| Change History | Complete list of historical versions of study NCT01255605 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
Maternal aneamia, low birth weight, prematurity [ Time Frame: At delivery ] [ Designated as safety issue: No ] The investigators will check pregnant women haemoglobin level a level< 11g/dl will be considered as anaemia birth weight<2500g will be considered as low birth weight prematurity designs any birth before 37 gestation weeks |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso) | ||||
| Official Title ICMJE | 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. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: The investigators make thick and thin blood smear and collect a few drops of blood on the 3MM paper Whatmann Schleicher-Schuell. |
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| 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). |
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| Condition ICMJE | Malaria, Pregnancy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 772 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Burkina Faso | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01255605 | ||||
| Other Study ID Numbers ICMJE | PIC/INSSA/UPB-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Mamoudou Cisse, Centre Muraz | ||||
| Study Sponsor ICMJE | Université Polytechnique de Bobo-Dioulasso | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Université Polytechnique de Bobo-Dioulasso | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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