Malaria, PregnancyNCT01255605
Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)
An observational study of Malaria, Pregnancy, run by Université Polytechnique de Bobo-Dioulasso at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria, Pregnancy
- How many people
- 772 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Sep 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Residing in the health area of Lafiabougou or secteur 24
- Having agreed to give free and informed consent
Who cannot join
- Bleeding from during the pregnancy
- eclampsia
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut Supérieur des Sciences de la Santé/Université Polytechnique de Bobo-Dioulasso
Bobo-Dioulasso, Houet, 1091
About this study
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.
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.
Read the 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.
- Conditions
- Malaria, Pregnancy
- Keywords
- Intermittent preventive treatment with sulfadoxin-pyrimethamine, in Bobo-Dioulasso peri-urban areas, 5 years after its implementation, Burkina Faso.
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery
Secondary outcomes (1)
Maternal anemia, congenital malaria,low birth weight, prematurity.
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.
Measured: Maternal anemia: at antenatal clinics and at delivery. Congenital malaria: at delivery. Low birth weight: at delivery. Prematurity: at delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startSep 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 772 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Polytechnique de Bobo-Dioulasso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mamoudou Cisse, Centre Muraz
- Investigators
- Mamoudou Cisse, MD, Principal investigator, Centre MURAZ Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255605
- Sponsor's protocol ID
- PIC/INSSA/UPB-01
- Status last verified
- Jun 2012
- First submitted
- 6 Dec 2010
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01255605
- Acronym / sponsor ID
- PIC/INSSA/UPB-01
- Conditions
- Malaria, Pregnancy
- Keywords
- Intermittent preventive treatment with sulfadoxin-pyrimethamine, in Bobo-Dioulasso peri-urban areas, 5 years after its implementation, Burkina Faso.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 772 participants (actual)
- Lead sponsor
- Université Polytechnique de Bobo-DioulassoUniversity, hospital or other
- Study start
- Sep 2010
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Residing in the health area of Lafiabougou or secteur 24
- Having agreed to give free and informed consent
Key exclusion criteria (2 listed)
- Bleeding from during the pregnancy
- eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamoudou Cisse, MD principal investigator
Centre MURAZ Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, Pregnancy, run by Université Polytechnique de Bobo-Dioulasso at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral and placental malaria (time frame: Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2012.