NOPE37: Angiogenic Factors for Managing Term Preeclampsia
Recruiting · NCT07193680 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Intervention arm: expectant management if sFlt-1/PlGF<38Standard care: elective delivery at 37 weeks of gestation
What this trial is about
This study tests the hypothesis that, in women with preeclampsia without severe features, delivery management based on sFlt-1/PlGF would reduce the rate of induction of labor without worsening the rate of progression to preeclampsia with severe features and other maternal complications.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
23 locations listed.
- Hospital Universitario de A Coruña - A Coruña, Spain
- Hospital General Universitari Dr. Balmis - Alicante, Spain
- Vall d'Hebron Hospital Campus - Barcelona, Spain
- Hospital Universitario de Cabueñes - Cabueñes, Spain
- Hospital Universitario Puerta del Mar - Cadiz, Spain
- Hospital General Universitario de Elche - Elche, Spain
- Hospital Universitario de Getafe - Getafe, Spain
- Hospital Universitari de Girona Doctor Josep Trueta - Girona, Spain
- Hospital Universitario San Cecilio - Granada, Spain
- Hospital Universitario de Jerez - Jerez de la Frontera, Spain
- Hospital Materno Infantil de Gran Canaria - Las Palmas de Gran Canaria, Spain
- Hospital Universitari Arnau de Vilanova - Lleida, Spain
- Hospital universitario 12 de Octubre - Madrid, Spain
- Hospital Clínico Universitario Virgen de la Arrixaca - Murcia, Spain
- Hospital Universitari Son Espases - Palma de Mallorca, Spain
- Hospital Universitario Virgen de Valme - Seville, Spain
- Hospital Universitario Virgen Macarena - Seville, Spain
- Hospital Universitari de Tarragona Joan XXIII - Tarragona, Spain
- Consorci Sanitari de Terrassa - Terrassa, Spain
- Hospital Universitari MútuaTerrassa - Terrassa, Spain
- Hospital Universitario de Torrejón - Torrejón, Spain
- Hospital Universitario Lozano Blesa - Zaragoza, Spain
- Hospital Universitari Dexeus - Barcelona, BARCELONA, Spain