- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255605
Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)
June 15, 2012 updated by: Dr Mamoudou Cisse, Université Polytechnique de Bobo-Dioulasso
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.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
772
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Houet
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Bobo-Dioulasso, Houet, Burkina Faso, 1091
- Institut Supérieur des Sciences de la Santé/Université Polytechnique de Bobo-Dioulasso
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral and placental malaria
Time Frame: Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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. |
Maternal anemia: at antenatal clinics and at delivery. Congenital malaria: at delivery. Low birth weight: at delivery. Prematurity: at delivery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mamoudou Cisse, MD, Centre Muraz Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 6, 2010
First Submitted That Met QC Criteria
December 6, 2010
First Posted (Estimate)
December 7, 2010
Study Record Updates
Last Update Posted (Estimate)
June 18, 2012
Last Update Submitted That Met QC Criteria
June 15, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIC/INSSA/UPB-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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