Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tampere University; University of Tampere
• Collaborators: Academy of Finland; Foundation for Paediatric Research, Finland
• Treatments: Azithromycin; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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