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

Phase 3 Completed 137 enrolled Royal College of Surgeons, Ireland Health Research Board - Trials Methodology Research Network · collab

RandomizedParallel-groupQuadruple-blindPrevention

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).

Timeline

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

Outcome

Missed primary endpoint

paper The risk of the composite measure of placental dysfunction did not differ between groups (25% aspirin vs 21% placebo; P=.796). PMID 38461094 ↗

paper aspirin did not reduce the risk of adverse perinatal outcome in pregnancies complicated by prepregnancy diabetes mellitus. PMID 38461094 ↗

Publications

Finnegan C, Dicker P, Asandei D, Higgins M, O'Gorman N, O' Riordan M, Dunne F, Gaffney G, Newman C, McAuliffe F, Ciprike V, Fernandez E, Malone FD, Breathnach FM. The IRELAnD study-investigating the role of early low-dose aspirin in diabetes mellitus: a double-blinded, placebo-controlled, randomized trial. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101297. doi: 10.1016/j.ajogmf.2024.101297. Epub 2024 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	150 mg	Oral