NOPE37: Angiogenic Factors for Managing Term Preeclampsia

Not Applicable

Not yet recruiting

• Conditions: Preeclampsia

• Registration Number: NCT07193680
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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)

Study Timeline

• Study First Submitted: 2025-07-21
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-20
• Primary Completion: 2027-12
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 750

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite maternal outcome	through study completion, an average of 2 months	The primary outcome is a composite poor maternal outcome, defined as maternal mortality, severe maternal morbidity (eclampsia, HELLP syndrome, thromboembolic disease, pulmonary edema, or placental abruption), preeclampsia with severe features, and major postpartum hemorrhage (\>1000 mL).

Secondary Outcome Measures

Name	Time	Method
Method of delivery	through study completion, an average of 2 months	Method of delivery, onset of labor, operative vaginal delivery for fetal distress, cesarean section for fetal distress.
Maternal admission to ICU	through study completion, an average of 2 months	Maternal admission to ICU (yes/no)
Maternal satisfaction measured by the questionnaires EuroQol-5D-5L (EQ-5D-5L):	through study completion, an average of 2 months	Five-dimension questionnaire converted into a utility index (range \<0 to 1; higher scores = better health) and a visual analogue scale (0-100; higher scores = better perceived health)
Need of maternal corticosteroids	through study completion, an average of 2 months	Need of maternal corticosteroids (yes/no)
Maternal NT-proBNP levels	through study completion, an average of 2 months	Maternal NT-proBNP levels (pg/mL)
Neonatal morbidity	through study completion, an average of 2 months	Neonatal morbidity is defined as the occurrence of at least one of the following: 5-minute Apgar score \<7, NICU admission, fetal death, neonatal death, sepsis, hypoglycemia, transient tachypnea of the newborn, respiratory distress syndrome, meconium aspiration syndrome, periventricular leukomalacia, intraventricular hemorrhage, seizures, necrotizing enterocolitis, neonatal jaundice requiring phototherapy, neonatal birthweight \<2500 g, or elective early-term delivery (37+0-38+6 weeks of gestation).
Prematurity	through study completion, an average of 2 months	Prematurity (delivery \<37 weeks of gestation), yes/no
Days of neonatal admission to NICU	through study completion, an average of 2 months	duration of neonatal admission to NICU (days)
Days of maternal admission to ICU	through study completion, an average of 2 months	Duration of maternal admission to ICU (days)
Birthweight	through study completion, an average of 2 months	Birthweight in grams
Metabolic acidosis	through study completion, an average of 2 months	Umbilical artery pH \<7.10 and base excess \<-12 mmol/L (yes/no)
Maternal satisfaction measured by the Generic Short Patient Experiences Questionnaire (GS-PEQ)	through study completion, an average of 2 months	Ten-item measure scored 1-5 per item (total range 10-50; higher scores = better patient experiences).
Gestational age at delivery	through study completion, an average of 2 months	Gestational age at delivery (weeks and days)
Birthweight percentile	through study completion, an average of 2 months	Birthweight percentile (%) according to local reference charts

Trial Locations

Locations (1)

Vall d'Hebron Hospital Campus; 🇪🇸 Barcelona, Spain