Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05284474

Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Fetal Growth Retardation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Growth Disorders Hypertension, Pregnancy-Induced Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Diseases Pre-Eclampsia Preeclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Major fetal malformations or genetic disorders
  • Fetal death
  • Refusal to give informed consent
  • Stage IV FGR

Treatment and study plan

soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)

Diagnostic Test

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)

Primary outcomes

  1. Fetal and Neonatal complications

    Time frame: 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.

  2. Composite adverse maternal outcome

    Time frame: 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 outcomes

  1. Maternal perceived stress

    Time frame: 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

  2. Other perinatal outcomes

    Time frame: 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.

  3. Number of ultrasounds per participant

    Time frame: During pregnancy (before and after 37 weeks)

    Mean and sd or median and IQR in each group

Study contacts

Contact information is provided by the study sponsor or research team.

Manel Mendoza, MD, PhD

CONTACT

[email protected]

+34934893000 ext. 3085

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Instituto de Salud Carlos III
  • Roche Diagnostics GmbH

Registry information

Official study title

Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)

Acronym: earlyGRAFD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2022
Registry last updated
Jun 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.