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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
340
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)
Complejo Hospitalario Universitario de A Coruña
A Coruña, Spain
Hospital Universitario General de Alicante
Alicante, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Vall d'hebron Barcelona Hospital Campus
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Dexeus
Barcelona, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitario de Getafe
Getafe, Spain
Hospital Universitario de Cabueñes
Gijón, Spain
...and 17 more locations
Fetal and Neonatal complications
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.
Time frame: During pregnancy and up to 28 days after delivery
Composite adverse maternal outcome
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.
Time frame: During pregnancy and up to 28 days after delivery
Maternal perceived stress
Mean and sd or median and IQR of the score obtained in the perceived stress scale in each group
Time frame: At inclusion and 4 weeks later
Other perinatal outcomes
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.
Time frame: During pregnancy and up to 28 days after delivery
Number of ultrasounds per participant
Mean and sd or median and IQR in each group
Time frame: During pregnancy (before and after 37 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.