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Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

NCT00131235 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1320

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Academy of Finland

    collaborator OTHER

  • Foundation for Paediatric Research, Finland

    collaborator OTHER

  • Tampere University

    lead OTHER

Principal Investigators

  • Per Ashorn, MD, PhD · Tampere University, Faculty of Medicine and Health Technology

  • Kenneth M Maleta, MBBS, PhD · Kamuzu University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2007-06-30
Completion
2027-12-31

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00131235 on ClinicalTrials.gov