CompletedPhase 3

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

Ireland137 participantsStarted 2018-09-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Preeclampsia - Change in blood pressure (Hypertension)

Timeframe: From 20 weeks gestation to delivery

Preeclampsia - Change in Proteinuria

Timeframe: From 20 weeks gestation to birth

Birth weight

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

Preterm birth

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

Perinatal mortality

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

Trial details

NCT IDNCT03574909

SponsorRoyal College of Surgeons, Ireland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-25

View on ClinicalTrials.gov More Pre-Gestational Diabetes trials