Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Current interventions as of 16/04/2014:
Randomised participants will be advised to start 150 mg of aspirin or placebo once per night within 24 hours of randomisation until 36 weeks’ gestation or when
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/03/2013: 1. Aged 18 years or over 2. Singleton pregnancies 3. Live fetus at 11-13 weeks of gestation 4. High-risk for preterm pre-eclampsia will be defined at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A [PAPP-A] and placental growth factor [PlGF]). Previous inclusion criteria until 12/03/2013: All singleton pregnancies with a live foetus at 11+0 - 13+6 weeks of gestation.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/04/2014: 1. Multiple pregnancies 2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment 3. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness 4. Bleeding disorders such as Von Willebrand?s disease 5. Peptic ulceration 6. Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication 7. Age < 18 years 8. Women taking low-dose aspirin regularly 9. Concurrent participation in another drug trial or at any time within the previous 28 days 10. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol Exclusion criteria from 12/03/2013 to 28/04/2014: 1. Multiple pregnancies 2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment 3. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness 4. Bleeding disorders such as Von Willebrand?s disease 5. Peptic ulceration 6. Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication 7. Age < 18 years Original exclusion criteria until 12/03/2013: 1. Major foetal abnormalities identified at the 11+0 - 13+6 weeks assessment 2. Women who are unconscious or severely ill 3. Learning difficulties 4. Serious mental illness 5. Women with bleeding disorders 6. Peptic ulceration 7. Hypersensitivity to aspirin 8. Under the age of 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 12/03/2013: Development of pre-eclampsia, requiring delivery before 37 weeks' gestation Previous primary outcome measures until 12/03/2013: Development of pre-eclampsia, measures will be obtained at the end of the pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/04/2016: 1. To determine the effect of low-dose aspirin on adverse outcome of pregnancy at 37 weeks 3.1. PE requiring delivery at >37 weeks 3.2. SGA (37 weeks 3.3. Miscarriage or stillbirth at >37 weeks 3.4. Placental abruption (clinically or on placental examination) at >37 weeks 3.5. Composite of any of the above 4. To determine the effect of low-dose aspirin on neonatal mortality and morbidity 4.1. Neonatal intensive care unit admission 4.2. Intraventricular haemorrhage (IVH) grade II or above - defined as bleeding into the ventricles 4.2.1. Grade II (moderate) – IVH occupies 50% of the lateral ventricle volume 4.2.3. Grade IV (severe) – haemorrhagic infarction in periventricular white matter ipsilateral to a large IVH 4.3. Ventilation - defined as need of positive pressure (continuous positive airway pressure [CPAP] or nasal continuous positive airway pressure [NCPAP]) or intubation 4.4. Neonatal sepsis - confirmed bacteraemia in cultures 4.5. Anaemia – defined as low haemoglobin and/or haematocrit requiring blood transfusion 4.6. Respiratory distress syndrome - defined as need of surfactant and ventilation as a result of prematurity 4.7. Necrotising enterocolitis (NEC) requiring surgical intervention. NEC is defined by a combination of clinical, radiological and laboratory features: 4.7.1. Systemic signs - apnoea, bradycardia, temperature instability, hypotension 4.7.2. Intestinal signs - abdominal distension, gastric residuals, bloody stools, absent bowel sounds, abdominal tenderness, peritonitis 4.7.3. Radiological signs - pneumatosis intestinalis or portal venous air, pneumoperitoneum 4.7.4. Laboratory changes - metabolic and or respiratory acidosis, thrombocytopaenia, DIC 4.8. Composite of any of the above 5. To determine the effect of low-dose aspirin on the incidence of neonatal birthweight below the 3rd, 5th and 10th centile 5.1. Birthweight will be recorded in the participants’ medical notes and birthweight p | — |
Countries
Belgium, Greece, Israel, Italy, Spain, United Kingdom
Outcome results
None listed