Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Current interventions as of 27/02/2026:
Randomisation will be provided by a computer-generated programme hosted by King's Clinical Trials Unit, in random permuted blocks, using a minimisation algorith
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
16 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Singleton pregnancy 2. Live fetus at 35+0-36+6 weeks’ gestation 3. Able to provide informed and documented consent
Exclusion criteria
Exclusion criteria: 1. Age <16 years 2. Women with established PE 3. Known major fetal abnormality 4. Participating in another intervention study that influences the outcomes of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivery with PE as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP) 2021.14. The definition of PE is chronic hypertension or new onset hypertension (systolic blood pressure (BP) should be =140 mm Hg and/or diastolic =90 mm Hg, on at least two occasions four hours apart BP >140/90 mm Hg) = 20 weeks of gestation together with any of the following: 1. Proteinuria, defined as =300 mg in 24 hours or urinary creatinine ratio =30 mg/mmol (0.3 mg/mg) or two readings of at least ++ on dipstick analysis of midstream or catheter urine specimens if no 24-hour collection is available; or 2. Maternal organ dysfunction, defined as any one of the following: 2.1. Acute kidney injury with creatinine >90 µmol/l or 2.2. Liver involvement with elevated transaminases (alanine or aspartate aminotransferase [ALT or AST] >40 IU/L or twice the normal concentration) or 2.3. Haematological complications (thrombocytopaenia with platelet count 95th percentile, umbilical artery PI (UA-PI) >95th percentile, or middle cerebral artery PI (MCA PI) <5th percentile All outcome measures will be recorded during the routine care appointment and during childbirth. When the participants do not gIve birth at the chosen hospital, then the outcome is taken from their medical record. | — |
Secondary
| Measure | Time frame |
|---|---|
| All outcome measures will be recorded during the routine care appointment and during childbirth. When the participants do not gIve birth at the chosen hospital, then the outcome is taken from their medical record. 1. Emergency caesarean section, defined as any caesarean section after spontaneous onset or induction of labour. A caesarean section without prior labour will be considered as elective 2. Neonatal care unit stay for =48 consecutive hours up to primary hospital discharge home or 28 days of life, whichever is earlier Other secondary outcomes: 1. GH, defined as systolic BP =140 mm Hg and/or diastolic =90 mm Hg, on at least two occasions 4 hours apart, and developing at =20 weeks’ gestation in previously normotensive women (i.e., BP 97 µmol/L or a doubling in its value 2.4.4. Abnormal liver enzymes (ALT or AST >67 IU/litre) 3. ‘Severe features’ of PE (one or more), and its components, according to ACOG 201915 and without alternative diagnoses: 3.1. Severe hypertension (as defined below) 3.2. Platelet count 67 IU/L) and persistent severe right upper quadrant abdominal or epigastric pain unresponsive to medication and not otherwise accounted for by alternative diagnoses 3.4. Serum creatinine >97 µmol/L or a doubling of value in the absence of other renal disease 3.5. Pulmonary edema 3.6. New-onset headache unresponsive to medication 3.7. Visual disturbances 4. Preeclampsia Integrated Estimate of Risk Score (PIERS) combined adverse maternal outcome, and its components, derived from Delphi consensus (with the exception of the Glasgow coma score 24 hr, not due to a post-ictal state) 4.2.2. Eclampsia (generalized convulsion in the absence of a history of epilepsy) 4.2.3. Blindness (either retinal or cortical, defined as loss of visual acuity in the presence of intact pupillary response to light) 4.3. Cardiorespiratory complications (one or more of): 4.3.1. Uncontrolled hypertension (requiring administration of 3 or more different parenteral [intravenous or intra | — |
Countries
England, United Kingdom
Outcome results
None listed