Early onset pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Prospective cohort study of development and validation of prediction model for risk of adverse outcomes in women admitted with early onset pre-eclampsia.
Women will be recruited into the study betwee
these will include:
1. History:
1.1. Symptoms of headache, epigastric pain , nausea or visual disturbance
1.2. Pre existing hypertension, renal disease, diabetes mellitus, autoimmune disease and
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women admitted with diagnosis of 'superimposed pre-eclampsia': this was defined as new-onset proteinuria (as defined previously) in women with chronic hypertension and no proteinuria at base line. In women who had proteinuria at base line, the diagnosis of preeclampsia required an elevated serum alanine aminotransferase concentration (>70 U per litre) or worsening hypertension (either two diastolic BP of at least 110 mm Hg four hours apart or one diastolic measurement of at least 110 mm Hg if the woman had been treated with an antihypertensive drug), plus one of the following: increasing proteinuria, persistent severe headaches, or epigastric pain. 2. Women with diagnosis of HELLP syndrome with no proteinuria or hypertension 3. Women with one episode of eclamptic seizures with no hypertension or proteinuria 4.1. Gestational age between 20+0 weeks and 33+6 weeks 4.2. Pre-eclampsia defined as new onset hypertension (systolic BP = 140 mm Hg or diastolic BP = 90 mm Hg on 2 occasions 4 -6 hours apart in women) after 20 weeks of pregnancy and presence of proteinuria (= 2+ in urine dipstick or PCR ratio of greater than 30mg/mmol or 300 mg of protein excretion in 24 hours) 4.3. Be capable of understanding the information provided, with use of an interpreter if required 4.4. Give written informed consent
Exclusion criteria
Exclusion criteria: 1. There is occurrence of the outcome (including recurrent eclamptic seizures) prior to testing 2. There is insufficient time for gaining informed consent. 3. The mother does not comprehend spoken and written English adequately and a translator is not available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse maternal outcome at 48 hours and at discharge that includes maternal death 2. Other adverse effects: 2.1. Involvement of Central Nervous System - eclamptic seizures 2.2. Glasgow coma score of less than 13 2.3. Stroke or RIND (Reversible Ischaemic Neurological Deficit) 2.4. Cortical blindness 2.5. Retinal detachment] 2.6. Posterior reversible encephalopathy 2.7. Bell's palsy 2.8. Hepatic dysfunction 2.9. Hematoma, or rupture 2.10. Cardio respiratory - need for positive ionotrope support 2.11. Myocardial ischaemia or infarction 2.12. Infusion of any third parenteral antihypertensive 2.13. At least 50% FIO2 for greater than 1 hour 2.14. Intubation 2.15. Pulmonary oedema 2.16. Renal-acute renal insufficiency (creatinine >200uM) 2.17. Dialysis 2.18. Haematological-transfusion of any blood product Added 27/02/2015: 2.19. Delivery at a gestational age less than 34 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse perinatal outcome at birth and by discharge that includes one or more of the following: 1. Perinatal or infant mortality 2. Bronchopulmonary dysplasia (defined as oxygen requirement at 36 weeks corrected gestation unrelated to an acute respiratory episode) 3. Necrotising enterocolitis (include only Bell's stage 2 or 3. Definition - evidence of pneumotosis intestinalis on abdominal x-ray and/or surgical intervention) 4. Grade III/IV intraventricular haemorrhage 5. Cystic periventricular leukomalacia 6. Stage 3-5 retinopathy of prematurity 7. Hypoxic ischaemic encephalopathy (Apgar score /= -16 in first 60 minutes associated with abnormal conscious level (lethargy, stupor or coma) and seizures and/or poor/weak suck and/or hypotonia and/or abnormal reflexes). | — |
Countries
United Kingdom
Outcome results
None listed