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.
Conditions
Interventions
Trade Name: Nu-Seals 75mg Gastro-Resistant Tablets - Aspirin, Acetylsalycylic Acid
Product Name: Nu-Seals Acetylsalycylic Acid - Aspirin
Pharmaceutical Form: Gastro-resistant tablet
Sponsors
University College Dublin CRC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients included in our study are : 1. Nulliparous women 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To Determine : 1. Proportion of eligible women who agree to participate in the pilot study of a three arm randomised controlled trial 2. Compliance with the study protocol 3. Proportion of women in whom it was possible to obtain trans- abdominal uterine artery Doppler at 14 weeks gestation 4. Proportion of women with completed screening test that are issued the screening result within one week of the test. 5. The acceptability of undergoing a screening test and or of taking aspirin to women in their first pregnancy ;Secondary Objective: 1. Rate of severe pre-eclampsia, defined as blood pressure =140/90mmHg requiring delivery at <34 completed weeks, eclampsia, HELLP syndrome or the need for magnesium sulphate for maternal seizure prophylaxis. 2. Rate of fetal IUGR, defined as birth-weight <5th centile for gestational age. 3. Spontaneous or iatrogenic delivery at <34 completed weeks. 4. Rate of admission to the NICU. 5. Rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small for gestational age infants. ;Primary end point(s): Outcome Measures will include measures of feasibility: 1. Compliance with set study protocol – assessing the number of patients who underwent all designated assessments within the designated time period for set assessments as specified in the study database 2. The number of women who were approached to take part in the study, the number who agreed to take part and the number who dropped out or were subsequently included on an intention to treat basis only 3. The time taken to complete Assessments 1 and 2 4. The ease of obtaining trans-abdominal uterine artery Doppler assessment in the first trimester and the number of women in whom this was possible 5. The number of women who had correct and timely calculation of the Fetal Medicine Foundation Risk if in group 3 and how long it took on average (days) to obtain this assessment and subsequently prescribe aspirin if appropriate 6. The accept | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will include the: 1. Rate of pre-eclampsia. This is defined as those with BP 140/90 with +1 proteinuria occurring on two-occasions after 20-weeks gestation 2. Rate of hypertension in pregnancy 3. Rate of fetal intrauterine growth restriction (IUGR), defined as birth-weight <10th centile for gestational age 4. Spontaneous or iatrogenic delivery at <34 completed weeks. 5. Rate of admission to the neonatal intensive care unit 6. Rate of placental abruption, any reported death (stillbirth, neonatal or infant death) and small-for-gestational-age-infants 7. Economic viability of screen-test positive indicated Aspirin versus routine Aspirin for prevention of pre-eclampsia 8. Study the associations between PPARGC1ß and CNTN4 genotype, serum and urinary TxM, and rates of pre-eclampsia and IUGR. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Ireland
Contacts
Public ContactRabia Hussain
UCD
Outcome results
None listed