Investigating the Role of Aspirin in patients with preexisting Diabetes in order to reduce the occurance of pregnancy complications.
- Conditions
- 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.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2014-001332-11-IE
- Lead Sponsor
- Royal College of Surgeons
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 23
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 <12 weeks’ gestational age with documented fetal cardiac activity
4.Those willing to sign voluntarily a statement of informed consent to participate in the study.
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method