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IRELAnD: Investigating the Role of Early Low-dose Aspirin in Diabetes

NCT03574909 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-03-27

No results posted yet for this study

Summary

To investigate the effect of aspirin therapy initiated in the first trimester of pregnancy in women with pregestational type I or type II diabetes on a composite clinical measure of placental dysfunction (preeclampsia, preterm birth less than 34 weeks, birthweight below the 10th centile or perinatal mortality).

Conditions

  • Pre-Gestational Diabetes

Interventions

DRUG

Aspirin

Tromalyt® 150mg prolong release capsule for oral ingestion. The capsule contains 150mg of anti-platelet agent acetylsalicylic acid, maize starch and Sucrose 20:80. The capsule also contains Copovidone (Kollidon VA-64), Eudragit L, Ethylcellulose and Triacetin. The capsule is made with gelatin, erythrosine, quinoline yellow, titanium dioxide.

DRUG

Placebos

Size 0 hard gelatin capsules containing 99% of microcrystalline cellulose and 1% of magnesium stearate (Sanitatis®). The capsules contain 198mg microcrystalline cellulose and 2mg of magnesium stearate

Sponsors & Collaborators

  • Health Research Board - Trials Methodology Research Network

    collaborator OTHER

  • Royal College of Surgeons, Ireland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-08-25
Completion
2023-08-25

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574909 on ClinicalTrials.gov