NOPE37: Angiogenic Factors for Managing Term Preeclampsia
ConditionPreeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Singleton pregnancy
Preeclampsia without severe features according to the ACOG definition
Antegrade diastolic flow in the umbilical artery Doppler
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention arm: expectant management if sFlt-1/PlGF<38
Other interventionIf 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 gestation
Other interventionIn the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Standard care: elective delivery at 37 weeks of gestationActive comparator 1 intervention
Group B: Intervention arm: expectant management if sFlt-1/PlGF<38Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
through study completion, an average of 2 monthsSecondary outcomes
1
Neonatal morbidity
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).
Time frame
through study completion, an average of 2 months2
Method of delivery
Method of delivery, onset of labor, operative vaginal delivery for fetal distress, cesarean section for fetal distress.
Time frame
through study completion, an average of 2 months3
Maternal admission to ICU
Maternal admission to ICU (yes/no)
Time frame
through study completion, an average of 2 months4
Days of maternal admission to ICU
Duration of maternal admission to ICU (days)
Time frame
through study completion, an average of 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Source ClinicalTrials.gov