E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
The condition known as pre-eclampsia (high blood pressure and protein in the urine) can lead to serious problems for mother and baby. Aspirin Treatment can help to reduce the risk of complications. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 acceptability of undergoing a screening test and or of taking aspirin to women in their first pregnancy. This will be assessed through an anonymous rated and opinion based questionnaire women will complete in the second trimester of pregnancy to obtain their views on the screening test as well as taking Aspirin in pregnancy
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 PPARGC1β and CNTN4 genotype, serum and urinary TxM, and rates of pre-eclampsia and IUGR.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Delivery of last patient recruited |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |