drugset / Trial / NCT05612984
Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth
Phase 3
Withdrawn
Johns Hopkins Bloomberg School of Public Health
Aga Khan University · collabChristiana Care Health Services · collabColumbia University · collabInstitut Africain de Sante Publique · collabZvitambo Institute for Maternal and Child Health Research · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This trial will evaluate the impact of an integrated intervention of daily maternal calcium, aspirin, and multiple micronutrients (CAMMS) compared to iron-folic acid (IFA) during pregnancy on preterm birth and other adverse birth outcomes. Both interventions will be delivered through existing antenatal service platforms using context-specific strategies informed by formative research incorporating human-centered design processes to achieve high acceptability and high adherence, in three low-income countries with diverse contexts: Burkina Faso, Pakistan, and Zimbabwe.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 81 mg | — |
| Subject | Calcium carbonate | Other / unclassified | 500 mg | — |
| Subject | UNIMMAP MMS | Unknown | — | — |