Fetal Growth Retardation, Placenta Diseases, Preeclampsia
Conditions
Keywords
fetal growth restriction, small for gestational age, PlGF, sFlt-1, Doppler
Brief summary
This is a multicentre, open-label, randomized controlled trial. A total of 340 singleton pregnancies with an EFW ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.
Interventions
DIAGNOSTIC_TESTsoluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)
soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) will be incorporated to the management of early-onset small fetuses (estimated fetal weight ≤10th percentile)
Sponsors
Instituto de Salud Carlos III
Roche Diagnostics GmbH
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women of at least 18 years old * Singleton pregnancy * Ultrasonographic EFW ≤10th percentile between 26+0 and 31+6 weeks of gestation * Gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates.
Exclusion criteria
* Major fetal malformations or genetic disorders * Fetal death * Refusal to give informed consent * Stage IV FGR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal and Neonatal complications | During pregnancy and up to 28 days after delivery | stillbirth, neonatal death, artery cord pH ≤7.0, respiratory distress syndrome, required invasive ventilatory support, grade III or IV intraventricular hemorrhage, neonatal sepsis, necrotizing enterocolitis, neonatal seizures, pneumonia, meningitis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy, Apgar score \<7 at 5 minutes, or elective delivery at \<28 weeks of gestation. |
| Composite adverse maternal outcome | During pregnancy and up to 28 days after delivery | Progression to PE with severity features; progression to hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome (LDH \>600 IU/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevated more than twice the upper limit of normal, and the platelet count less than 100 X 109/L); eclampsia, stroke, hepatic hematoma or rupture; oliguria (urine output of \<400 mL during 24 hours, or need for treatment with furosemide to maintain urine output at \>400 mL for 24 hours); cardiovascular dysfunction (need for inotropic support, left ventricle failure, or myocardial infarction); placental abruption; maternal death; maternal admission to intensive care unit \>48 hours, and/or requirement for blood transfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal perceived stress | At inclusion and 4 weeks later | Mean and sd or median and IQR of the score obtained in the perceived stress scale in each group |
| Other perinatal outcomes | During pregnancy and up to 28 days after delivery | transient tachypnea, non-invasive ventilatory support, hypoglycemia, neonatal jaundice (treated with phototherapy), rate of elective deliveries \< 30 weeks, \<34 weeks and \< 37 weeks for FGR and/or PE, birthweight \<3 rd and \<10th percentiles, mode of delivery (vaginal, instrumental vaginal delivery and Cesarean), rate of Cesarean delivery for abnormal CTG, median maternal stay in ICU, median neonatal stay in N-ICU, maternal corticosteroids (single dose, complete course), prenatal magnesium sulfate (at least 4h) for preterm delivery. |
| Number of ultrasounds per participant | During pregnancy (before and after 37 weeks) | Mean and sd or median and IQR in each group |
Countries
Spain
Contacts
Primary ContactManel Mendoza, MD, PhD
Outcome results
None listed