Pre-eclampsia prevention by timed birth at term 2 (PREVENT-2): a randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16931476

Enrollment

8000

Registered

2025-10-27

Start date

2025-11-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia Pregnancy and Childbirth

Interventions

Randomisation will be provided by a computer-generated programme hosted by King's Clinical Trials Unit, in random permuted blocks, using a minimisation algorithm to ensure balance in the treatment all

Eligibility

Sex/Gender

Female

Age

16 Years to 60 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 outcomes of this study

Design outcomes

Primary

Measure	Time frame
1. Pre-eclampsia at delivery is measured using the 2021 ISSHP definition of pre-eclampsia at the day of delivery 2. Hypertension is measured using systolic and diastolic blood pressure readings taken on at least two occasions four hours apart at the day of delivery 3. Proteinuria is measured using 24-hour urine protein collection, urinary protein-to-creatinine ratio, or dipstick analysis of midstream or catheter urine specimens at the day of delivery 4. Neurological complications are measured using clinical assessment and medical record review at the day of delivery 5. Haematological complications are measured using full blood count and coagulation profile at the day of delivery 6. Pulmonary oedema is measured using clinical examination and chest imaging (e.g. chest X-ray or ultrasound) at the day of delivery 7. Acute kidney injury is measured using serum creatinine levels at the day of delivery 8. Liver involvement is measured using serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at the day of delivery 9. Uteroplacental dysfunction is measured using estimated fetal weight by ultrasound and Doppler indices (uterine artery PI, umbilical artery PI, middle cerebral artery PI) at the day of delivery	—

Measure

Time frame

1. Pre-eclampsia at delivery is measured using the 2021 ISSHP definition of pre-eclampsia at the day of delivery 2. Hypertension is measured using systolic and diastolic blood pressure readings taken on at least two occasions four hours apart at the day of delivery 3. Proteinuria is measured using 24-hour urine protein collection, urinary protein-to-creatinine ratio, or dipstick analysis of midstream or catheter urine specimens at the day of delivery 4. Neurological complications are measured using clinical assessment and medical record review at the day of delivery 5. Haematological complications are measured using full blood count and coagulation profile at the day of delivery 6. Pulmonary oedema is measured using clinical examination and chest imaging (e.g. chest X-ray or ultrasound) at the day of delivery 7. Acute kidney injury is measured using serum creatinine levels at the day of delivery 8. Liver involvement is measured using serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at the day of delivery 9. Uteroplacental dysfunction is measured using estimated fetal weight by ultrasound and Doppler indices (uterine artery PI, umbilical artery PI, middle cerebral artery PI) at the day of delivery

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Secondary

Measure	Time frame
1. Gestational hypertension is measured using blood pressure readings on at least two occasions four hours apart at =20 weeks’ gestation 2. Components of the 2021 ISSHP definition of pre-eclampsia are measured using clinical and laboratory assessments at the day of delivery 2.1. Pre-eclampsia is measured using the 2019 ACOG definition at the day of delivery 2.2. Gestational hypertension or severe hypertension is measured using blood pressure readings at the day of delivery 2.3. Proteinuria is measured using 24-hour urine collection, protein-to-creatinine ratio, or dipstick analysis at the day of delivery 2.4. In the absence of proteinuria, maternal organ dysfunction is measured using the following: 2.4.1. Pulmonary oedema is measured using clinical examination and imaging at the day of delivery 2.4.2. Platelet count 97 µmol/L or a doubling of baseline is measured using serum biochemistry at the day of delivery 2.4.4. ALT or AST >67 IU/L is measured using liver function tests at the day of delivery 3. Severe features of pre-eclampsia are measured using clinical and laboratory assessments at the day of delivery 3.1. Severe hypertension is measured using blood pressure readings =160/110 mm Hg at the day of delivery 3.2. Platelet count 67 IU/L and persistent right upper quadrant or epigastric pain is measured using liver function tests and clinical assessment at the day of delivery 3.4. Serum creatinine >97 µmol/L or doubling of baseline is measured using serum biochemistry at the day of delivery 3.5. Pulmonary oedema is measured using clinical examination and imaging at the day of delivery 3.6. New-onset headache unresponsive to medication is measured using clinical assessment at the day of delivery 3.7. Visual disturbances are measured using clinical assessment at the day of delivery 4. PIERS combined adverse maternal outcome is measured using Delphi consensus criteria and clinical records at the day of delivery 4.1. Maternal death is	—

Measure

Time frame

1. Gestational hypertension is measured using blood pressure readings on at least two occasions four hours apart at =20 weeks’ gestation 2. Components of the 2021 ISSHP definition of pre-eclampsia are measured using clinical and laboratory assessments at the day of delivery 2.1. Pre-eclampsia is measured using the 2019 ACOG definition at the day of delivery 2.2. Gestational hypertension or severe hypertension is measured using blood pressure readings at the day of delivery 2.3. Proteinuria is measured using 24-hour urine collection, protein-to-creatinine ratio, or dipstick analysis at the day of delivery 2.4. In the absence of proteinuria, maternal organ dysfunction is measured using the following: 2.4.1. Pulmonary oedema is measured using clinical examination and imaging at the day of delivery 2.4.2. Platelet count 97 µmol/L or a doubling of baseline is measured using serum biochemistry at the day of delivery 2.4.4. ALT or AST >67 IU/L is measured using liver function tests at the day of delivery 3. Severe features of pre-eclampsia are measured using clinical and laboratory assessments at the day of delivery 3.1. Severe hypertension is measured using blood pressure readings =160/110 mm Hg at the day of delivery 3.2. Platelet count 67 IU/L and persistent right upper quadrant or epigastric pain is measured using liver function tests and clinical assessment at the day of delivery 3.4. Serum creatinine >97 µmol/L or doubling of baseline is measured using serum biochemistry at the day of delivery 3.5. Pulmonary oedema is measured using clinical examination and imaging at the day of delivery 3.6. New-onset headache unresponsive to medication is measured using clinical assessment at the day of delivery 3.7. Visual disturbances are measured using clinical assessment at the day of delivery 4. PIERS combined adverse maternal outcome is measured using Delphi consensus criteria and clinical records at the day of delivery 4.1. Maternal death is

—

Countries

England, United Kingdom

Contacts

Public ContactLucy Singh

lucy.singh@kcl.ac.uk+44 2032990000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026