Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF).
- Who it may be relevant to
- Registry conditions: Fetal Growth Retardation, Preeclampsia, Placenta Diseases. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)
Overview
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.
Interventions
- 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)
Primary outcome measures
- Fetal and Neonatal complications [Time frame: During pregnancy and up to 28 days after delivery]
- Composite adverse maternal outcome [Time frame: During pregnancy and up to 28 days after delivery]
Secondary outcome measures (3)
- Maternal perceived stress [Time frame: At inclusion and 4 weeks later]
- Other perinatal outcomes [Time frame: During pregnancy and up to 28 days after delivery]
- Number of ultrasounds per participant [Time frame: During pregnancy (before and after 37 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Spain · 27 centers
- Complejo Hospitalario Universitario de A Coruña — A Coruña
- Hospital Universitario General de Alicante — Alicante
- Hospital Universitari Germans Trias i Pujol — Badalona
- Vall d'hebron Barcelona Hospital Campus — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Hospital Universitari Dexeus — Barcelona
- Hospital Universitario Puerta del Mar — Cadiz
- Hospital General Universitario de Elche — Elche
- … and 19 more centers
Identifiers
NCT: NCT05284474 · PR(AMI)113/2022