Preeclampsia
Conditions
Keywords
preeclampsia, angiogenic factors, expectant management
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)
Interventions
OTHERIntervention 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.
OTHERStandard 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.
Sponsors
Instituto de Salud Carlos III
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Days of maternal admission to ICU | through study completion, an average of 2 months | Duration of maternal admission to ICU (days) |
| Gestational age at delivery | through study completion, an average of 2 months | Gestational age at delivery (weeks and days) |
| Birthweight | through study completion, an average of 2 months | Birthweight in grams |
| Birthweight percentile | through study completion, an average of 2 months | Birthweight percentile (%) according to local reference charts |
| 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). |
| Days of neonatal admission to NICU | through study completion, an average of 2 months | duration of neonatal admission to NICU (days) |
| Metabolic acidosis | through study completion, an average of 2 months | Umbilical artery pH \<7.10 and base excess \<-12 mmol/L (yes/no) |
| 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) |
| 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). |
| Prematurity | through study completion, an average of 2 months | Prematurity (delivery \<37 weeks of gestation), yes/no |
Countries
Spain
Contacts
Primary ContactErika Bonacina, MD, PhD
Outcome results
None listed