NOPE37: Angiogenic Factors for Managing Term Preeclampsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention arm: expectant management if sFlt-1/PlGF<38, Standard care: elective delivery at 37 weeks of gestation.
- Who it may be relevant to
- Registry conditions: Preeclampsia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial
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.
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)
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 outcome measures
- Composite maternal outcome [Time frame: through study completion, an average of 2 months]
Secondary outcome measures (12)
- Neonatal morbidity [Time frame: through study completion, an average of 2 months]
- Method of delivery [Time frame: through study completion, an average of 2 months]
- Maternal admission to ICU [Time frame: through study completion, an average of 2 months]
- Days of maternal admission to ICU [Time frame: through study completion, an average of 2 months]
- Gestational age at delivery [Time frame: through study completion, an average of 2 months]
- Birthweight [Time frame: through study completion, an average of 2 months]
- Birthweight percentile [Time frame: through study completion, an average of 2 months]
- Prematurity [Time frame: through study completion, an average of 2 months]
- Days of neonatal admission to NICU [Time frame: through study completion, an average of 2 months]
- Metabolic acidosis [Time frame: through study completion, an average of 2 months]
- Need of maternal corticosteroids [Time frame: through study completion, an average of 2 months]
- Maternal NT-proBNP levels [Time frame: through study completion, an average of 2 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 23 centers
- Hospital Universitari Dexeus — Barcelona
- Hospital Universitario de A Coruña — A Coruña
- Hospital General Universitari Dr. Balmis — Alicante
- Vall d'Hebron Hospital Campus — Barcelona
- Hospital Universitario de Cabueñes — Cabueñes
- Hospital Universitario Puerta del Mar — Cadiz
- Hospital General Universitario de Elche — Elche
- Hospital Universitario de Getafe — Getafe
- … and 15 more centers
Identifiers
NCT: NCT07193680 · PR(AMI)392-2023