Status:
ACTIVE_NOT_RECRUITING
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
Lead Sponsor:
Tampere University
Collaborating Sponsors:
Academy of Finland
Foundation for Paediatric Research, Finland
Conditions:
Malaria
Sexually Transmitted Diseases
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and r...
Detailed Description
Maternal anaemia, preterm deliveries and low birth weight are common in Sub-Saharan Africa and contribute significantly to the ill-health of pregnant women and infants. The present study is based on t...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age \>= 15 years
- Ultrasound confirmed pregnancy
- Quickening
- Foetal age 14-26 gestation weeks
- Maternal availability for follow-up during the entire study period
Exclusion
- Known maternal tuberculosis, diabetes, kidney disease or liver disease
- Any severe acute illness warranting hospital referral at enrollment visit
- Mental disorder that may affect comprehension of the study or success of follow-up
- Twin pregnancy
- Pregnancy complications evident at enrollment visit (moderate to severe oedema, blood hemoglobin \[Hb\] concentration \< 50 g/l, systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg)
- Prior receipt of azithromycin during this pregnancy
- Receipt of sulfadoxine and pyrimethamine within 28 days of enrollment
- Known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
- History of anaphylaxis
- History of any serious allergic reaction to any substance, requiring emergency medical care
- Concurrent participation in any other clinical trial
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2027
Estimated Enrollment :
1320 Patients enrolled
Trial Details
Trial ID
NCT00131235
Start Date
December 1 2003
End Date
December 31 2027
Last Update
March 25 2025
Active Locations (1)
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1
College of Medicine, University of Malawi
Mangochi, Mangochi District, Malawi