NCT07193680

NOPE37: Angiogenic Factors for Managing Term Preeclampsia

Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants with preeclampsia without severe features between 36 and 38+6 weeks, who do not meet any exclusion criteria, will be randomly assigned to two groups: * In the study group, if angiogenic factors are normal (sFlt-1/PlGF \<38), delivery will be delayed until 39 weeks; if any other medical condition is present, delivery will be scheduled according to the specific protocol for it. * In the study group, if angiogenic factors are abnormal (sFlt-1/PlGF ≥38), labor will be induced at ≥37 weeks. * In the control group, labor will be recommended at 37 weeks, as is currently standard. * In both groups, NT-proBNP levels will be measured at enrollment. * In both groups, a satisfaction questionnaire will be completed at enrollment and 4 weeks after delivery. * In both groups, if any of the following is present, delivery will be recommended immediately (within 24 hours): 1. preeclampsia with severe features according to ACOG criteria 2. decreased fetal movements 3. absent or reversed diastolic flow in the umbilical artery 4. non-reassuring CTG 5. biophysical profile score ≤6 6. oligohydramnios (largest vertical pocket \<2 cm)

Conditions

• Preeclampsia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-04
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2025-09-26
• Last updated: 2025-12-11

Locations

23 sites across 1 country: Spain