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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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6 July 2015 |
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Main ID: |
ISRCTN13355246 |
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Date of registration:
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16/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early aspirin to improve pregnancy outcome in diabetes
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Scientific title:
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'IRELAnD': Investigating the Role of Early Low-dose Aspirin in preexisting Diabetes': An open-label randomized pilot study |
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Date of first enrolment:
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16/12/2014 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN13355246 |
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Study type:
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Interventional |
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Study design:
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Prospective, randomized, pilot study. (Prevention)
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Phase:
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Fionnuala
Breathnach |
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Address:
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Royal College of Surgeons in Ireland
Rotunda Hospital
D1
Dublin
Ireland |
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All women with type I or type II diabetes of at least 6 months duration prior to conception
2. Ability to speak and read English
3. Singleton pregnancy at <12 weeks’ gestational age
4. Those willing to sign voluntarily a statement of informed consent to participate in the study
Exclusion criteria: 1. Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin)
2. Peptic ulcer disease
3. Known bleeding diathesis
4. Multifetal gestation
5. Severe early-onset preeclampsia in a previous pregnancy
6. Patient already on aspirin
7. Age under 18 years
8. Miscarriage prior to randomization
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Placental dysfunction, including preeclampsia, in pregnant women with pregestational diabetes
Pregnancy and Childbirth
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Intervention(s)
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Study arms:
Women with pregestational diabetes are randomized to receive aspirin 75mg or no aspirin.
Intervention:
Aspirin Acetylsalycylic Acid 75mg tablet (Nu-Seals®PA 943/6/1) once daily by oral ingestion from first trimester (initiated between 8+0 and 11+6 weeks) to 36 weeks gestation for women with pregestational diabetes mellitus (type I or II).
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Primary Outcome(s)
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1. Proportion of eligible women who agree to participate in the pilot study
2. Compliance with the study protocol, as judged by platelet function monitoring
3. Proportion of study participants who complete the study, with complete ascertainment of laboratory markers of glycaemic control, renal function and platelet function at all scheduled timepoints
Will be measured within 4 weeks of delivery of each participant (i.e. within 35 weeks of recruitment).
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Secondary Outcome(s)
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Examination, through dynamic platelet function assay, of antiplatelet effect among women with pregestational diabetes when compared with platelet function in diabetic women not taking antiplatelet therapy.
Will be measured within 4 weeks of delivery of each participant (i.e. within 35 weeks of recruitment).
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Secondary ID(s)
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IRELAnD_PILOT_V1
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2014-0011332-11
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Source(s) of Monetary Support
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Friends of the Rotunda Hospital (Ireland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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