Placental dysfunction, including preeclampsia, in pregnant women with pregestational diabetes Pregnancy and Childbirth
Conditions
Interventions
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 in
Sponsors
Royal College of Surgeons in Ireland
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Ireland
Outcome results
None listed