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COMBI Trial

Cotrimoxazole for Mothers to Improve Birthweight in Infants

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202107707978619
Enrollment
1000
Registered
2021-07-20
Start date
2021-09-13
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases Pregnancy and Childbirth

Interventions

Sponsors

Zvitambo Institute for Maternal and Child Health Research
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Confirmed pregnant Known HIV status in the current pregnancy Screened at antenatal booking Willing to receive all their antenatal care at one of the study clinics

Exclusion criteria

Exclusion criteria: Currently receiving or eligible to receive cotrimoxazole prophylaxis Contraindication to cotrimoxazole Any other acute or chronic condition that might interfere with the study, as judged by the research clinician

Design outcomes

Secondary

MeasureTime frame
Child neurodevelopment;Child language;Child behaviour;Child functional impairment;Child growth;Lean mass index;Skinfold thicknesses;Child death or hospitalization;Proportion low birth weight;Gestational age;Proportion preterm;Proportion small-for-gestational age;Weight-for-age Z score;Length-for-age Z-score;Head circimference-for-age Z-score;Fetal loss;Maternal hospitalization or death;Neonatal hospitalisation or death

Primary

MeasureTime frame
Infant birth weight

Countries

Zimbabwe

Contacts

Public ContactVirginia Sauramba

Research Administration and Compliance Manager

v.sauramba@zvitambo.com+263242306028

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 12, 2026