Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,320

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

June 30, 2007

Study Completion Date

December 31, 2027

Conditions
MalariaSexually Transmitted DiseasesPreterm BirthPregnancy
Interventions
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."

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."

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."

Trial Locations (1)

Unknown

College of Medicine, University of Malawi, Mangochi

All Listed Sponsors
collaborator

Academy of Finland

OTHER

collaborator

Foundation for Paediatric Research, Finland

OTHER

lead

Tampere University

OTHER