Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth

NCT05612984 | Withdrawn Phase 3 DMC

• 1 other identifier: INV-036663
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total preterm birth

  Gestational age at birth \< 37 weeks, stratified by spontaneous and indicated.

  At birth

Secondary Outcomes (16)

• Total very early preterm birth

  At birth

• Total early preterm birth

  At birth

• Low birth weight

  At birth

• Very low birth weigh

  At birth

• Small for gestational age

  At birth

Other Outcomes (3)

• Infant birth length and birth head circumference

  birth

• Tolerance of CAMMS compared to IFA

  Up to 42 days post-partum

• Safety of CAMMS compared to IFA

  Up to 42 days post-partum

Study Arms (2)

Calcium aspirin multiple micronutrients

EXPERIMENTAL

500 mg elemental calcium (as 1250 mg calcium carbonate) 81 mg aspirin 1 tablet United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formula, which is a Multiple Micronutrient Supplement (MMS) for pregnant women

Combination Product: Calcium aspirin multiple micronutrients

Iron folic acid

ACTIVE COMPARATOR

60 mg iron + 400 μg folic acid given as a combined tablet

Dietary Supplement: Iron-folic Acid

Interventions

Calcium aspirin multiple micronutrients COMBINATION_PRODUCT

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.

Also known as: CAMMS

Calcium aspirin multiple micronutrients

Iron-folic Acid DIETARY_SUPPLEMENT

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.

Also known as: IFA

Iron folic acid

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman, confirmed pregnant by urinary pregnancy test
• \<20 weeks' gestation determined by fetal ultrasound exam;
• Pregnancy must be intrauterine; multiple fetus pregnancies are eligible.
• Women must be willing and able to give informed consent;
• willing to receive antenatal visits at one of the study clinics.
• In Burkina Faso, women must be willing to take monthly sulfadoxine-pyrimethamine.

You may not qualify if:

• Pregnant women who are currently taking aspirin, calcium, or MMS;
• have a history of peptic ulcer or have any other contraindications to any of the study drugs;
• have acute or chronic condition that might interfere with the study as judged by the research clinician including severe anemia defined as Hb\<5 g/dL;
• have other reasons which, at the study research physician's discretion, mean that receipt of the study drugs or participation in the trial would not be advisable.
• NOTE: Women who have been started on IFA by MoH or private health care provider but are willing discontinue the IFA dispensed by MoH and to be randomized to IFA or CAMMS will not be excluded.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Aga Khan University: collaborator
• Institut Africain de Sante Publique: collaborator
• Zvitambo Institute for Maternal and Child Health Research: collaborator
• Christiana Care Health Services: collaborator
• Columbia University: collaborator

MeSH Terms

Conditions

Obstetric Labor, Premature; Toxemia; Perinatal Death

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Humphrey, ScD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pregnant women will be individually randomized to daily CAMMS or IFA from recruitment (at 6\<20 weeks gestation) to delivery.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 14, 2022
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: About 2 years after the end of the trial when primary and secondary outcomes have been reported in the peer reviewed literature.