Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler
- Conditions
- Fetal Growth Retardation
- Interventions
- Procedure: Management based on sFlt-1/PlGF values
- Registration Number
- NCT04502823
- Brief Summary
Open randomized non-inferiority controlled trial to examine the use of angiogenic factors (instead of feto-placental Doppler) for fetal growth restriction at term to reduce the rate of labor inductions, without worsening perinatal outcomes.
- Detailed Description
Pregnant women with estimated fetal weight (EFW) \< 10th centile between 36+0 and 37+6 weeks of gestation (WG) will receive complete ultrasonographic assessment consisting of feto-placental Doppler, amniotic fluid measurement and biophysical profile assessment. The cases not meeting any exclusion criteria will be offered to participate in this trial. After giving their informed consent a blood sample will be drawn in all of them and they will undergo randomization into two arms.
1. Intervention arm: In women allocated to the intervention group, the soluble fms-like tyrosine kinase/placental growth factor (sFlt-1/PlGF) result will be revealed to the investigators that will act according to the results of sFlt/PlGF:
* Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended at ≥37 weeks.
* Fetuses with sFlt-1/PlGF \<38, weekly follow up will be recommended until delivery (at ≥40 weeks).
2. Control arm: In women allocated to the control group, the sFlt-1/PlGF result will be blinded to caregivers. Routine Doppler-based clinical care will be used to counsel women. Following the Doppler classification:
* Fetuses with EFW below the 3rd centile or below the 10th centile accompanied by any impaired fetoplacental Doppler, elective delivery will be recommended at at ≥37 weeks.
* Fetuses with EFW above the 3rd centile without any fetoplacental Doppler abnormality, elective delivery will be recommended at at ≥40 weeks.
In both arms, fetuses will receive weekly follow-up from randomization to delivery consisting on feto-placental Doppler sFlt-1/PlGF and CTG. If any of the following is present at any time, earlier delivery will be recommended:
* sFlt-1/PlGF ≥38 (only in the intervention group),
* absent or reverse end-diastolic flow at the umbilical artery Doppler or DV PI\>95th centile
* non-reassuring CTG
* preeclampsia
* diminished fetal movements
* biophysical profile ≤ 6 or oligohydramnios (deepest pocket \<2 cm).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1088
- Pregnant women ≥ 16 years of age.
- Singleton pregnancy.
- Ultrasonographic estimated fetal weight <10th centile.
- Gestational age between 36+0 and 37+6 weeks.
- Major fetal malformations or genetic disorders.
- Fetal death.
- Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI>95th centile.
- Non-reassuring cardiotocography (CTG).
- Preeclampsia.
- Diminished fetal movements.
- Biophysical profile ≤ 6.
- Oligohydramnios
- Refusal to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Management based on sFlt-1/PlGF values Management based on sFlt-1/PlGF values
- Primary Outcome Measures
Name Time Method Adverse perinatal outcomes 4-6 weeks Cesarean delivery for non-reassuring fetal status or neonatal acidosis (artery cord potential of hydrogen (pH) \<7.15 + base excess \> -12 milliequivalent/L)
- Secondary Outcome Measures
Name Time Method Rate of Cesarean delivery 4-6 weeks Percentage of women that required a Cesarean delivery
Rate of total deliveries at <37, <38, <39 and <40 weeks of gestation 4-6 weeks Percentage of women that delivered at \<37, \<38, \<39 and \<40 weeks of gestation
Rate of maternal complications 4-6 weeks Percentage of women with adverse outcomes (composite)
Rate of Induction of labor 4-6 weeks Percentage of women that required an induction of labor
Rate of neonatal complications 4-10 weeks Percentage of newborns with adverse outcomes (composite)
Rate of elective delivery 4-6 weeks Percentage of women that required an elective delivery
Time of neonatal admission in intensive care unit 4-6 weeks Days in in intensive care of newborns that required admission
Rate of preeclampsia 4-6 weeks Percentage of women that developed preeclampsia
Rate of neonatal admission in intensive care unit 4-6 weeks Percentage of newborns that required admission in intensive care
Rate of perinatal complications 4-6 weeks Percentage of perinatal adverse outcomes (composite)
Rate of elective deliveries at <37, <38, <39 and <40 weeks of gestation 4-6 weeks Percentage of women that delivered electively at \<37, \<38, \<39 and \<40 weeks of gestation
Rate of newborns with birthweight <2000 and <2500 grams 4-6 weeks Percentage of women that delivered a newborn with a birthweight \<2000 and \<2500 grams
Trial Locations
- Locations (20)
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario de A Coruña
🇪🇸A Coruña, Spain
Hospital Universitari Mútua Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario de Torrejon
🇪🇸Torrejón De Ardoz, Spain
Hospital de Terrassa
🇪🇸Terrassa, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell
🇪🇸Sabadell, Spain
Hospital Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Universitari Joan XXIII
🇪🇸Tarragona, Spain
Hospital Universitario de Cabueñes
🇪🇸Cabueñes, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Spain
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Spain
Hospital Universitari Vall d'hebron
🇪🇸Barcelona, Spain
Hospital Sant Joan de Deu de Manresa
🇪🇸Manresa, Spain
Hospital Universitari Doctor Josep Trueta
🇪🇸Girona, Spain