Investigating the Role of Early Low-dose Aspirin in Diabetes

Phase 1

• Conditions: Pregestational type I or type II diabetes; MedDRA version: 21.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-000770-29-IE
• Lead Sponsor: The Rotunda Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-11
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

•Ability to comprehend the Patient Information Leaflet and to provide signed and dated informed consent.
•Willing to comply with all study procedures and be available for the duration of the study
•Female, age >18 years
•Singleton pregnancy, ongoing at 11 – 13+6 weeks’ gestation
•Pre-pregnancy diagnosis of type I or type II diabetes of at least 6 months’ duration
•Fulfillment of each criterion must be clearly evidenced (in lab reports or correspondence) and/or documented in the medical records.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin)
•Active or recurrent peptic ulceration (2 or more distinct episodes of proven ulceration or bleeding), repetitive gastric symptoms or history of intolerance of NSAIDs
•Known bleeding diathesis (hypothrombinaemia, haemophilia, von Willebrands’ disease)
•Multifetal gestation
•Breastfeeding
•Severe early-onset preeclampsia in a previous pregnancy
•Patient already on aspirin at the time of screening
•Established chronic renal disease (progressive loss of renal function of at least 3 months’ duration), clinically significant liver disorder, hyperuricemia (Gout), glucose-6-phosphate dehydrogenase (G6PD) deficiency or heart failure (This exclusion criterion will be assessed from patient’s medical history not from screening laboratory tests).
•Blood clotting disorder or treatment with anticoagulants at the time of recruitment or with anti-platelet therapy (Anticoagulants commenced after recruitment will not constitute exclusion from the trial).
•Macroalbuminuria (24-hour urinary protein 300g or greater, or spot urinary protein/creatinine ratio >0.3 in the first trimester or dipstick proteinuria >/= +2
•Chronic hypertension (antihypertensive therapy in first trimester)
•Inability to speak or read English
•Use of any other medication that would constitute a risk to a patient taking aspirin in the opinion of the investigator ((including Interferon-a and Methotrexate)
•Inflammatory bowel disease (Crohn’s disease or Ulcerative colitis)
•Use of any other investigational medicinal product within the previous 30 days
•The presence of any illness or condition that might interfere with the patient’s ability to comply with the study procedures
•The presence of any illness or condition (including recent surgery) that renders the patient unsuitable for treatment with aspirin in the opinion of the investigator
•Hyperemesis gravidarum

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified