PlGF as a diagnostic test for pre-eclampsia

PARROT - Placental growth factor to Assess and diagnose hypeRtensive pRegnant wOmen: a stepped wedge Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16842031

Enrollment

504

Registered

2016-05-19

Start date

2016-06-13

Completion date

Unknown

Last updated

2019-05-05

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

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine

Interventions

The trial is a stepped-wedge cluster randomisation trial, and all units will begin recruiting to the ‘not revealed’ phase at the trial beginning. The step-lengths are 5 weeks, with a new site chosen a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women between 20+0 and 36+6 weeks’ of gestation 2. Suspected pre-eclampsia 3. Viable fetus 4. Singleton 5. Aged 18 years or over 6. Able to give written informed consent

Exclusion criteria

Exclusion criteria: Confirmed diagnosis of preterm pre-eclampsia at the point of enrolment

Design outcomes

Primary

Measure	Time frame
Time from first presentation with hypertension to antenatal services to having a confirmed, documented diagnosis of pre-eclampsia (as defined by ISSHP 2014 statement). The time points of evaluation are first presentation with suspected disease to confirmed diagnosis of pre-eclampsia. This is a participant level outcome.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 08/06/2018: Secondary short-term maternal outcomes: 1. Test performance of the PlGF (vs. currently utilised tests) for clinically indicated delivery for diagnosed pre-eclampsia within 14 days 2. Systolic blood pressure =160 mmHg 3. Progression to severe pre-eclampsia (as defined by ACOG) 4. Placental abruption 5. Mode of onset (spontaneous, induced or pre-labour caesarean section) 6. Mode of delivery (spontaneous vaginal delivery, assisted vaginal delivery, caesarean section) 7. A composite of maternal adverse outcomes as defined by the fullPIERS consensus Additional descriptive secondary short-term maternal/fetal outcomes: 1. Maternal death 2. Use of anti-hypertensive drugs 3. Eclampsia 4. Disseminated intravascular coagulation 5. Pulmonary oedema 6. Antepartum haemorrhage 7. Postpartum haemorrhage 8. Estimated fetal weight (on ultrasound scan) <10th centile post-enrolment 9. Absent or reversed end diastolic flow (on umbilical artery Doppler) post-enrolment 10. Primary and additional indications for delivery (maternal hypertension not controlled by maximal therapy, biochemical abnormality, haematological abnormality, fetal compromise on ultrasound scan, fetal compromise on cardiotocography, severe maternal symptoms, 37 weeks’ gestation or specified other) Secondary short-term perinatal outcomes: 1. Gestational age at delivery 2. Stillbirth 3. Neonatal death prior to hospital discharge 4. Preterm birth (<37 weeks’ gestation) 5. Neonatal unit (NNU) admission for at least 4 hours 6. Birth weight 7. Bi	—

Measure

Time frame

Current secondary outcome measures as of 08/06/2018: Secondary short-term maternal outcomes: 1. Test performance of the PlGF (vs. currently utilised tests) for clinically indicated delivery for diagnosed pre-eclampsia within 14 days 2. Systolic blood pressure =160 mmHg 3. Progression to severe pre-eclampsia (as defined by ACOG) 4. Placental abruption 5. Mode of onset (spontaneous, induced or pre-labour caesarean section) 6. Mode of delivery (spontaneous vaginal delivery, assisted vaginal delivery, caesarean section) 7. A composite of maternal adverse outcomes as defined by the fullPIERS consensus Additional descriptive secondary short-term maternal/fetal outcomes: 1. Maternal death 2. Use of anti-hypertensive drugs 3. Eclampsia 4. Disseminated intravascular coagulation 5. Pulmonary oedema 6. Antepartum haemorrhage 7. Postpartum haemorrhage 8. Estimated fetal weight (on ultrasound scan) <10th centile post-enrolment 9. Absent or reversed end diastolic flow (on umbilical artery Doppler) post-enrolment 10. Primary and additional indications for delivery (maternal hypertension not controlled by maximal therapy, biochemical abnormality, haematological abnormality, fetal compromise on ultrasound scan, fetal compromise on cardiotocography, severe maternal symptoms, 37 weeks’ gestation or specified other) Secondary short-term perinatal outcomes: 1. Gestational age at delivery 2. Stillbirth 3. Neonatal death prior to hospital discharge 4. Preterm birth (<37 weeks’ gestation) 5. Neonatal unit (NNU) admission for at least 4 hours 6. Birth weight 7. Bi

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Countries

United Kingdom

Contacts

Public ContactKate Duhig

Outcome results

None listed

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