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

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal College of Surgeons, Ireland
• Collaborator: Health Research Board, Ireland
• Treatments: Aspirin; Platelet Aggregation Inhibitors; Titanium dioxide

Criteria

Inclusion Criteria:

• Singleton pregnancy with a pre-pregnancy diagnosis of type I or type II diabetes of at least 6 months' duration

Exclusion Criteria:

• • Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin)

• Peptic ulcer disease

• Known bleeding diathesis

• Multifetal gestation

• Severe early-onset preeclampsia in a previous pregnancy

• Patient already on aspirin

• Established chronic renal disease/ macroalbuminuria

• Chronic hypertension (antihypertensive therapy in first trimester)

• Current selective serotonin reuptake inhibitor (SSRI) use (or SSRI use within 7 days)

• Inability to speak or read English

• Age less than 18 years

• Use of any other investigational medicinal product within previous 30 days

• Presence of any illness or condition that might interfere with the patient's ability to comply with the study procedures