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Tracking Information | |||||||||||||
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First Received Date † | August 16, 2005 | ||||||||||||
Last Updated Date | July 3, 2008 | ||||||||||||
Start Date † | December 2003 | ||||||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00131235 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||||||
Brief Title † | Gestational Sulfadoxine-Pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth | ||||||||||||
Official Title † | Lungwena Antenatal Intervention Study. A Single-Centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-Pyrimethamine and Azithromycin | ||||||||||||
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 result in other health benefits both for the mother and the foetus/newborn. |
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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 the assumption that these adverse outcomes can be prevented by improved antimicrobial management of malaria and sexually transmitted infections (STI) among pregnant women. To test the hypothesis, a randomised clinical trial following Good Clinical Practice (GCP) is being carried out in Malawi, South-Eastern Africa. A total of 1320 consenting women who present at a rural antenatal clinic after 14 but before 26 completed gestation weeks will be enrolled. One third of the women will receive antenatal care according to national recommendations, including regular visits to health centre, screening for pregnancy complications, haematinic and vitamin A supplementation and two doses of presumptive malaria treatment with sulfadoxine-pyrimethamine. Another third will receive otherwise the same care, but sulfadoxine-pyrimethamine treatment is given at monthly intervals. The final third receives standard antenatal care, sulfadoxine-pyrimethamine treatment at monthly intervals and two doses of presumptive STI treatment with azithromycin. Women are monitored throughout pregnancy and delivery and newborn growth will be followed up for five years. The primary outcome measure is proportion of preterm births in the three study groups. Secondary maternal outcomes include anaemia and malaria parasitaemia during pregnancy, at delivery and at 1, 3, and 6 months after delivery, gestational weight gain and morbidity and STI prevalence after delivery. Secondary child outcomes consist of proportion of babies with low birth weight, mean birth weight, growth in infancy and childhood, incidence of malnutrition in infancy and childhood, and mortality. Additionally, information is collected on the development of malaria-specific humoral immunity in pregnancy and participant experiences from the study. Participant safety is systematically monitored throughout the intervention. |
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Study Phase | Phase III | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Enrollment † | 1320 | ||||||||||||
Estimated Completion Date | April 2011 | ||||||||||||
Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||||||
Ages | 15 Years and older | ||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | Malawi | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00131235 | ||||||||||||
Responsible Party | Per Ashorn, University of Tampere Medical School, Finland | ||||||||||||
Secondary IDs †† | |||||||||||||
Study Sponsor † | University of Tampere | ||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | University of Tampere | ||||||||||||
Verification Date | July 2008 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |