Using angiogenic blood tests to guide delivery timing for term preeclampsia
Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial
NA · Hospital Universitari Vall d'Hebron Research Institute · NCT07193680
This trial tests whether using an angiogenic blood test (sFlt-1/PlGF) to guide when to deliver can reduce inductions without causing more severe preeclampsia in people with preeclampsia without severe features at 36–38+6 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute (other) |
| Locations | 23 sites (Barcelona, BARCELONA and 22 other locations) |
| Trial ID | NCT07193680 on ClinicalTrials.gov |
What this trial studies
This randomized trial enrolls pregnant people with preeclampsia without severe features at 36+0 to 38+6 weeks and assigns them to angiogenic-marker–guided management or standard care. In the angiogenic group, sFlt-1/PlGF <38 leads to expectant management until 39 weeks while sFlt-1/PlGF ≥38 prompts induction at ≥37 weeks; the control group follows the standard recommendation of delivery at 37 weeks. Both groups have NT-proBNP measured at enrollment and complete a satisfaction questionnaire at enrollment and 4 weeks after delivery. Immediate delivery is recommended for predefined maternal or fetal warning signs such as development of severe features, abnormal umbilical artery Doppler, nonreassuring CTG, oligohydramnios, low biophysical profile, or decreased fetal movements.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a singleton pregnancy, confirmed gestational age, preeclampsia without severe features between 36+0 and 38+6 weeks, and antegrade diastolic umbilical artery flow are ideal candidates.
Not a fit: Patients with preeclampsia with severe features, abnormal or absent end-diastolic umbilical flow, fetal compromise, multiple pregnancy, fetal malformation, antiphospholipid syndrome, or any condition requiring immediate delivery are unlikely to benefit from the delayed-management strategy.
Why it matters
Potential benefit: If successful, this approach could safely reduce unnecessary early inductions and allow more pregnancies to reach 39 weeks when angiogenic markers are normal.
How similar studies have performed: Prior research shows sFlt-1/PlGF is useful for risk stratification and predicting progression of preeclampsia, but using it prospectively to delay delivery at term is relatively new and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Singleton pregnancy * Preeclampsia without severe features according to the ACOG definition * Antegrade diastolic flow in the umbilical artery Doppler * Gestational age between 36+0 and 38+6 weeks of gestation * Gestational age confirmed by fetal crown-rump length measurement in the first-trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates Exclusion Criteria: * Fetal death * Preeclampsia with severe features according to the ACOG definition, eclampsia, or any condition that requires immediate delivery * Absent or reversed end-diastolic flow in the umbilical artery Doppler * Non-reassuring CTG * Decreased fetal movements * Biophysical profile score ≤6 * Oligohydramnios * Refusal to provide informed consent * Fetal malformation * Placental abruption * Antiphospholipid antibody syndrome
Where this trial is running
Barcelona, BARCELONA and 22 other locations
- Hospital Universitari Dexeus — Barcelona, BARCELONA, Spain (RECRUITING)
- Hospital Universitario de A Coruña — A Coruña, Spain (RECRUITING)
- Hospital General Universitari Dr. Balmis — Alicante, Spain (RECRUITING)
- Vall d'Hebron Hospital Campus — Barcelona, Spain (RECRUITING)
- Hospital Universitario de Cabueñes — Cabueñes, Spain (RECRUITING)
- Hospital Universitario Puerta del Mar — Cadiz, Spain (RECRUITING)
- Hospital General Universitario de Elche — Elche, Spain (RECRUITING)
- Hospital Universitario de Getafe — Getafe, Spain (RECRUITING)
- Hospital Universitari de Girona Doctor Josep Trueta — Girona, Spain (RECRUITING)
- Hospital Universitario San Cecilio — Granada, Spain (RECRUITING)
- Hospital Universitario de Jerez — Jerez de la Frontera, Spain (RECRUITING)
- Hospital Materno Infantil de Gran Canaria — Las Palmas de Gran Canaria, Spain (RECRUITING)
- Hospital Universitari Arnau de Vilanova — Lleida, Spain (RECRUITING)
- Hospital universitario 12 de Octubre — Madrid, Spain (RECRUITING)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (RECRUITING)
- Hospital Universitari Son Espases — Palma de Mallorca, Spain (RECRUITING)
- Hospital Universitario Virgen de Valme — Seville, Spain (RECRUITING)
- Hospital Universitario Virgen Macarena — Seville, Spain (RECRUITING)
- Hospital Universitari de Tarragona Joan XXIII — Tarragona, Spain (RECRUITING)
- Consorci Sanitari de Terrassa — Terrassa, Spain (RECRUITING)
- Hospital Universitari MútuaTerrassa — Terrassa, Spain (RECRUITING)
- Hospital Universitario de Torrejón — Torrejón, Spain (RECRUITING)
- Hospital Universitario Lozano Blesa — Zaragoza, Spain (RECRUITING)
Study contacts
- Study coordinator: Erika Bonacina, MD, PhD
- Email: erika.bonacina@vallhebron.cat
- Phone: 003493 489 30 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preeclampsia, preeclampsia, angiogenic factors, expectant management