Fetal Growth Retardation
Conditions
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).
Interventions
PROCEDUREManagement based on sFlt-1/PlGF values
In women allocated to the intervention group, the 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 immediately (within 24h) at ≥37 weeks. * Fetuses with sFlt-1/PlGF \<38 weekly follow up will be recommended and delivery at ≥40 weeks.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women ≥ 16 years of age. 2. Singleton pregnancy. 3. Ultrasonographic estimated fetal weight \<10th centile. 4. Gestational age between 36+0 and 37+6 weeks.
Exclusion criteria
1. Major fetal malformations or genetic disorders. 2. Fetal death. 3. Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI\>95th centile. 4. Non-reassuring cardiotocography (CTG). 5. Preeclampsia. 6. Diminished fetal movements. 7. Biophysical profile ≤ 6. 8. Oligohydramnios 9. Refusal to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Cesarean delivery | 4-6 weeks | Percentage of women that required a Cesarean delivery |
| Rate of Induction of labor | 4-6 weeks | Percentage of women that required an induction of labor |
| Rate of neonatal admission in intensive care unit | 4-6 weeks | Percentage of newborns that required admission in intensive care |
| 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 elective delivery | 4-6 weeks | Percentage of women that required an elective delivery |
| Rate of maternal complications | 4-6 weeks | Percentage of women with adverse outcomes (composite) |
| Rate of perinatal complications | 4-6 weeks | Percentage of perinatal adverse outcomes (composite) |
| 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 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 |
| Rate of neonatal complications | 4-10 weeks | Percentage of newborns with adverse outcomes (composite) |
Countries
Spain
Outcome results
None listed