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Completed

NCT Number: NCT04502823

Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler

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.

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Key information

Conditions

Fetal Growth Retardation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de A Coruña, A Coruña, Spain

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About this study

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.

  • 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).
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women ≥ 16 years of age.
  • Singleton pregnancy.
  • Ultrasonographic estimated fetal weight <10th centile.
  • Gestational age between 36+0 and 37+6 weeks.

Exclusion criteria

  • 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.

Treatment and study plan

Management based on sFlt-1/PlGF values

Procedure

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.

Primary outcomes

  1. Adverse perinatal outcomes

    Time frame: 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 outcomes

  1. Rate of elective delivery

    Time frame: 4-6 weeks

    Percentage of women that required an elective delivery

  2. Rate of Cesarean delivery

    Time frame: 4-6 weeks

    Percentage of women that required a Cesarean delivery

  3. Rate of Induction of labor

    Time frame: 4-6 weeks

    Percentage of women that required an induction of labor

  4. Rate of neonatal admission in intensive care unit

    Time frame: 4-6 weeks

    Percentage of newborns that required admission in intensive care

  5. Time of neonatal admission in intensive care unit

    Time frame: 4-6 weeks

    Days in in intensive care of newborns that required admission

  6. Rate of preeclampsia

    Time frame: 4-6 weeks

    Percentage of women that developed preeclampsia

  7. Rate of neonatal complications

    Time frame: 4-10 weeks

    Percentage of newborns with adverse outcomes (composite)

  8. Rate of maternal complications

    Time frame: 4-6 weeks

    Percentage of women with adverse outcomes (composite)

  9. Rate of perinatal complications

    Time frame: 4-6 weeks

    Percentage of perinatal adverse outcomes (composite)

  10. Rate of total deliveries at <37, <38, <39 and <40 weeks of gestation

    Time frame: 4-6 weeks

    Percentage of women that delivered at <37, <38, <39 and <40 weeks of gestation

  11. Rate of elective deliveries at <37, <38, <39 and <40 weeks of gestation

    Time frame: 4-6 weeks

    Percentage of women that delivered electively at <37, <38, <39 and <40 weeks of gestation

  12. Rate of newborns with birthweight <2000 and <2500 grams

    Time frame: 4-6 weeks

    Percentage of women that delivered a newborn with a birthweight <2000 and <2500 grams

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler (GRAFD Trial)

Acronym: GRAFD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2020
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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