Recruiting
NOPE37: Angiogenic Factors for Managing Term Preeclampsia
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.
ClinicalTrials.gov IDNCT07193680
PhaseNA
Enrollment750
SponsorHospital Universitari Vall d'Hebron Research Institute
Age18 Years
SexFEMALE
Conditions studied
Preeclampsia
About this study
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.
Interventions
- Other: Intervention arm: expectant management if sFlt-1/PlGF<38 — If the angiogenic factors are normal (sFlt-1/PlGF \<38), expectant management will be followed until 39 weeks, instead of delivery at ≥37 weeks of gestation as in standard care for preeclampsia without severe features.
- Other: Standard care: elective delivery at 37 weeks of gestation — In the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.
Primary outcomes
- Composite maternal outcome (through study completion, an average of 2 months)
Eligibility information
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
Study locations
- Hospital Universitari Dexeus, Barcelona, BARCELONA 08024 Spain
- 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
Showing 10 of 23 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.