NOPE37: Angiogenic Factors for Managing Term Preeclampsia

N/ARecruitingNCT07193680

Hospital Universitari Vall d'Hebron Research Institute750 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

750

Conditions

Preeclampsia

Interventions

Intervention arm: expectant management if sFlt-1/PlGF<38OTHER

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.

Standard care: elective delivery at 37 weeks of gestationOTHER

In the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Hospital Universitari Dexeus

Barcelona, BARCELONA, Spain

Outcomes

Primary Outcomes

Composite maternal outcome

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).