Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler
- Conditions
- Fetal Growth RetardationPreeclampsiaPlacenta Diseases
- Interventions
- Diagnostic Test: soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)
- Registration Number
- NCT05284474
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 340
- 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.
- Major fetal malformations or genetic disorders
- Fetal death
- Refusal to give informed consent
- Stage IV FGR
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) Doppler protocol (as in controls) + sFlt-1/PlGF ratio cutoffs will be incorporated as follows: * \<38: Ultrasound biweekly in stage I FGR and every four weeks in SGA. In both cases delivery at ≥39-40 weeks. * 38-110: In stage I FGR and SGA ultrasound weekly. Delivery at ≥37 weeks. * \>110: In stage I FGR and SGA ultrasound weekly. Delivery at ≥36 weeks. * \>110 and concurrent preeclampsia: In stage I FGR and SGA ultrasound every 48h-72h. Delivery at ≥34 weeks. * \>201: Ultrasound every 48-72h, delivery at ≥34+0 weeks. If concurrent preeclampsia, delivery at ≥32+0 weeks. * \>655: Ultrasound every 48-72h, delivery at ≥32+0 weeks. If concurrent preeclampsia, delivery at ≥30+0 weeks. * \>1000: In cases with concurrent PE, delivery at ≥29+0 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (27)
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Complejo Hospitalario Universitario de A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario General de Alicante
🇪🇸Alicante, Spain
Vall d'hebron Barcelona Hospital Campus
🇪🇸Barcelona, Spain
Hospital Universitari Dexeus
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸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
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Spain
Hospital Materno Infantil de Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Spain
Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Spain
Hospital Universitari Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Virgen Macarena
🇪🇸Sevilla, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario Joan XXIII de Tarragona
🇪🇸Tarragona, Spain
Hospital Universitari Mútua Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario de Torrejón
🇪🇸Torrejón De Ardoz, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain