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

NCT03574909 | Completed Phase 3 DMC

• 2 other identifiers: Ireland-Rct-v1-02182018-000770-29
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Preeclampsia - Change in blood pressure (Hypertension)

  (i) greater than or equal to 140mmHg systolic or greater than or equal to 90mmHg diastolic on two occasions at least 4 hours apart after 20 weeks' gestation in a woman with a previously normal blood pressure. Or (ii) greater than or equal to 160mmHg systolic or greater than or equal to 110mmHg diastolic (such hypertension can be confirmed within a short interval (minutes) to facilitate timely antihypertensive therapy.perinatal mortality

  From 20 weeks gestation to delivery

• Preeclampsia - Change in Proteinuria

  Greater than or equal to 300mg per 24-hour urine collection, or a urinary protein: creatinine ratio greater than or equal to 0.3 or +3 proteinuria on dipstick urinalysis.

  From 20 weeks gestation to birth

• Birth weight

  Birth weight less than the 10th percentile for gestational age:

  weight will be measured on the day of birth and plotted on standard WHO UK RCPCH growth charts (per gender).

• Preterm birth

  -Preterm birth less than 34+0 weeks:

  Gestational age at birth will be verified with respect to the Estimated Date of Delivery calculated at the first study visit.

• Perinatal mortality

  Perinatal mortality

  Stillbirth or neonatal death after 24 completed weeks of gestation and within 28 days of birth.

Secondary Outcomes (19)

• Parameters of neonatal morbidity: Gestational age at delivery

  recorded at the time of birth, in weeks and days post Last Menstrual Period, or in accordance with ultrasound-derived gestational age, as above

• Parameters of neonatal morbidity: Birth weight

  recorded (in grams) on the day of birth)

• Parameters of neonatal morbidity: NICU admission

  Up to 10 days post birth

• Respiratory morbidity: Duration of invasive ventilation

  Up to 6 weeks after birth

• Duration of O2

  Up to 6 weeks after birth

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Treatment Arms: 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. Tromalyt® is trademark of Meda Pharma SL (Reg 59.210). There is no requirement for the first dose to be administered in the clinic under observation. The dosing frequency is once daily. Subjects will be instructed to take the study medication at the same time each day. No specific precautions are required in relation to concomitant food intake.

Drug: Aspirin

Control Arm

PLACEBO COMPARATOR

Placebos to be used are hard gelatin capsules (Sanitatis®) for patients randomized to the placebo arm. These capsules are externally identical to Tromalyt capsule. The capsules contain 198mg microcrystalline cellulose and 2mg of magnesium stearate (Sanitatis®) Placebo: There is no requirement for the first dose to be administered in the clinic under observation. The dosing frequency is once daily. Subjects will be instructed to take the study medication at the same time each day. No specific precautions are required in relation to concomitant food intake.

Drug: Placebos

Interventions

Placebos DRUG

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

Also known as: Sanitatis

Control Arm

Aspirin DRUG

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.

Also known as: Tromalyt

Treatment Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Research Board - Trials Methodology Research Network: collaborator

Study Sites (1)

Rotunda Hospital

Dublin, Ireland

Location

Related Publications (1)

• 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.

  PMID: 38461094 DERIVED

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: July 2, 2018
• Study Start: September 1, 2018
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: March 27, 2026

Record last verified: 2018-03

Locations

IE (1)