Pregestational diabetes represents a high-risk for evolution of preeclampsia (PET), with rates of PET within this group at approximately 20%. The combination of diabetes and preeclampsia places the pregnancy at heightened risk for hypoxia and stillbirth. Placental dysfunction, due to disordered early placental development, is central to the disease process.
Conditions
Interventions
Trade Name: Nu-Seals® 75 mg gastro-resistant coated tablets for oral ingestion that contain 75mg of the anti-platelet agent acetylsalicylic Acid as the active agent.
Product Name: Nu-Seals® 75 mg As
Sponsors
Royal College of Surgeons
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria People who satisfy all of the following may be included in the study: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria The following patients will be excluded from participation in the study: 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. Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The definitive IRELAND Study aims to investigate whether low-dose aspirin prescribed routinely to woman with pre-existing diabetes, initiated at 8+0 – 12 weeks’ gestation and continued until 36 weeks gestation may modify the risk of adverse perinatal outcomes related to placental dysfunction. The purpose of the pilot phase of this study is to determine rates of patient participation and compliance with aspirin therapy throughout pregnancy in this high-risk population. Primary objectives: 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 ;Secondary Objective: 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. ;Primary end point(s): The pilot phase of IRELAND is expected to be underpowered to assess efficacy of aspirin on perinatal outcome. This pilot will address uptake, compliance drop-out rates and effect of low-dose aspirin on platelet function in this group. Antiplatelet effect, compared between study (aspirin) and control (no aspirin) groups will be measured using a novel dynamic platelet assay. The biologic effect of low-dose aspirin on platelet function in this population with respect to variables that may affect bioavailability (maternal body mass index, gestational age, compliance) will also be measured. ;Timepoint(s) of evaluation of this end point: 4-6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The pilot phase of IRELAND is expected to be underpowered to assess efficacy of aspirin on perinatal outcome. This pilot will address uptake, compliance drop-out rates and effect of low-dose aspirin on platelet function in this group. Antiplatelet effect, compared between study (aspirin) and control (no aspirin) groups will be measured using a novel dynamic platelet assay. The biologic effect of low-dose aspirin on platelet function in this population with respect to variables that may affect bioavailability (maternal body mass index, gestational age, compliance) will also be measured. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Ireland
Contacts
Public ContactLIz Tully/Fionnuala Breathnach
Perinatal Ireland
Outcome results
None listed