A study of aspirin use in pregnancy to prevent high blood pressure and growth restriction of the fetus
- Conditions
- Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]Pre-eclampsia (PET) is a serious systemic condition, which affects 3-5% of all pregnancies and accounts for more than 50,000 of maternal deaths annually. Administration of anti-platelet agents to women at risk of PET with the use of LDA leads to a 17% reduction in the risk of developing pre-eclampsia.
- Registration Number
- EUCTR2013-004241-17-IE
- Lead Sponsor
- niversity College Dublin CRC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 500
Patients included in our study are :
1.Nulliparous women
2.Ability to speak and read English
3.Singleton pregnancy at <14 weeks
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Presence of fetal anomaly at the time of the first trimester scan
2. Women with known major risk factors for pre-eclampsia who should already be on Aspirin as per National Institute of Clinical Excellence (NICE) guidance; specifically chronic hypertension, underlying connective tissue, renal or vascular disorder, type 1 diabetes mellitus.
3. Age under 18 years old
4. Concurrent participation in another clinical trial
5. Participation in another clinical trial during the twelve weeks prior to study entry (screening period)
6. Contraindications to Aspirin therapy
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