Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth

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.

Conditions

• Preterm Labor
• Small for Gestational Age at Delivery
• Hypertensive Disorder of Pregnancy
• Low Birth Weight
• Neonatal Death

Interventions

COMBINATION_PRODUCT

Calcium aspirin multiple micronutrients

Women randomized to CAMMS will receive weekly blister cards containing all 3 components: 1 81 mg aspirin tablet, 1 UNIMMAP MMS, and 1 500-mg elemental calcium tablets. Blister packages will be labeled with times of day and days of week when tablets are to be taken. 4 weekly blister cards will be packaged in one unit box.

DIETARY_SUPPLEMENT

Iron-folic Acid

Women randomized to IFA will receive monthly (28-day) blister cards containing containing 1 combined IFA tablet to be taken each day. 1 4-weekly blister card will be packaged in one unit box.

Sponsors & Collaborators

• Aga Khan University

  collaborator OTHER

• Institut Africain de Sante Publique

  collaborator UNKNOWN

• Zvitambo Institute for Maternal and Child Health Research

  collaborator UNKNOWN

• Christiana Care Health Services

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Jean Humphrey, ScD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2026-06-30

Completion

2026-12-31