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Sponsors and Collaborators: |
University of Tampere Academy of Finland Foundation for Paediatric Research, Finland |
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Information provided by: | University of Tampere |
ClinicalTrials.gov Identifier: | NCT00131235 |
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.
Condition | Intervention | Phase |
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Malaria Sexually Transmitted Diseases Preterm Birth Pregnancy |
Drug: Sulfadoxine-pyrimethamine treatment twice during pregnancy Drug: Sulfadoxine-pyrimethamine at 4-week intervals Drug: Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 1320 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | April 2011 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Placebo Comparator
Standard antenatal care as described in intervention
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Drug: Sulfadoxine-pyrimethamine treatment twice during pregnancy
Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks. 2 placebo tablets for azithromycin taken at the same time points. |
Monthly SP: Experimental
Standard antenatal care + monthly intermittent presumptive treatment of malaria with sulfadoxine pyrimethamine, as described in intervention
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Drug: Sulfadoxine-pyrimethamine at 4-week intervals
Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks. 2 placebo tablets for azithromycin taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks. |
AZI-SP: Experimental
Standard antenatal care + monthly intermittent presumptive treatment of malaria with sulfadoxine pyrimethamine + two presumptive treatments of sexually transmitted infections and malaria with azithromycin, as described in intervention
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Drug: Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice
Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks. 2 azithromycin tablets (each 500 mg) taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks. |
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Malawi, Mangochi District | |
College of Medicine, University of Malawi | |
Mangochi, Mangochi District, Malawi |
Study Director: | Per Ashorn, MD, PhD | University of Tampere, Medical School |
Principal Investigator: | Kenneth M Maleta, MBBS, PhD | University of Malawi College of Medicine |
Principal Investigator: | Teija Kulmala, MD, PhD | University of Tampere, School of Public Health |
Responsible Party: | University of Tampere Medical School, Finland ( Per Ashorn ) |
Study ID Numbers: | SA-179787-1 |
Study First Received: | August 16, 2005 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00131235 |
Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Malaria STI Pregnancy Prevention |
Preterm birth Low birth weight Sub-Saharan Africa |
Pyrimethamine Birth Weight Protozoan Infections Sulfadoxine-pyrimethamine Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Malaria Sulfadoxine |
Genital Diseases, Male Folic Acid Body Weight Virus Diseases Genital Diseases, Female Azithromycin Sexually Transmitted Diseases Parasitic Diseases Premature Birth |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Anti-Infective Agents, Urinary Infection |
Folic Acid Antagonists Renal Agents Pharmacologic Actions Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses |