An interventional study of soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) in Fetal Growth Retardation, Preeclampsia and Placenta Diseases, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 27 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Diagnostic
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.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's planned enrollment of 340 is above the median of 150 across 110 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Small fetuses will be classified into 5 severity stages and managed as follows: * SGA: Estimated fetal weight (EFW) between p3 and p10 with normal Dopplers. Ultrasound/2 weeks, elective vaginal delivery at ≥39-40 weeks. * Stage I: EFW ≤p3 p or EFW p3-10 + UA PI \>p95 and/or UtA PI \>p95, and, at ≥32 weeks, CPR and/or MCA PI \<p5, in 2 occasions \>12 hours apart. Ultrasound weekly, elective vaginal delivery at ≥37 weeks. * Stage II: AEDF UA in 2 occasions \>12 hours apart. Ultrasound every 48-72h, elective Cesarean delivery at ≥34 weeks. * Stage III: DV PI \> p95 (or absent DV "a" wave) or reversed end-diastolic UA \>50% of cycles, in both cases in two occasions \> 6 hours apart. Ultrasound every 24-48h, elective Cesarean delivery at ≥30 weeks. * Stage IV: reversed DV "a" wave in two occasions \> 6 hours apart. Elective Cesarean delivery at ≥26 weeks.
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.
Diagnostic Test: soluble 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)
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)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2024; primary completion for Sep 2026, 26 months later.
Of 39 non-industry interventional studies with no phase under Fetal Growth Retardation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 52. This study's planned 26 months is below that.
Counting every sponsor, half of 40 studies reached it within 35 months; a quarter within 18 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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