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NCT05284474Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
340 (estimated)
First submitted
13 Feb 2022
Start date
3 Jun 2024
Primary completion date
1 Sept 2026
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
NCT number
NCT05284474

What you commit to

  • Study type: Interventional
  • Planned participants: 340
  • From 3 Jun 2024 to the primary completion date, 1 Sept 2026
  • 27 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Major fetal malformations or genetic disorders

Other

  • Fetal death
  • Refusal to give informed consent
  • Stage IV FGR

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complejo Hospitalario Universitario de A Coruña
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A CoruñaSpainUnknown status
Hospital Universitario General de Alicante
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AlicanteSpainUnknown status
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainUnknown status
Vall d'Hebron Barcelona Hospital Campus
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BarcelonaSpainUnknown status
Hospital Universitari Dexeus
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BarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitario Puerta del Mar
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CadizSpainUnknown status
Hospital General Universitario de Elche
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ElcheSpainUnknown status
Hospital Universitario de Getafe
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GetafeSpainUnknown status
Hospital Universitario de Cabueñes
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GijónSpainUnknown status
Hospital Universitari de Girona Doctor Josep Trueta
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GironaSpainUnknown status
Hospital Universitario San Cecilio
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GranadaSpainUnknown status
Hospital Universitario de Jerez de La Frontera
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Jerez de la FronteraSpainUnknown status
Hospital Materno Infantil de Gran Canaria
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Las Palmas de Gran CanariaSpainUnknown status
Hospital Universitari Arnau de Vilanova
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LleidaSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Hospital Universitari Son Espases
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Palma de MallorcaSpainUnknown status
Hospital Universitari Son Llatzer
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Palma de MallorcaSpainUnknown status
Corporacio Sanitaria Parc Tauli
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SabadellSpainUnknown status
Hospital Universitario de Canarias
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Santa Cruz de TenerifeSpainUnknown status
Virgen Macarena
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SevilleSpainUnknown status
Hospital Universitario Virgen de Valme
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SevilleSpainUnknown status
Hospital Universitario Joan XXIII de Tarragona
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TarragonaSpainUnknown status
Hospital Universitari Mutua Terrassa
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TerrassaSpainUnknown status
Consorci Sanitari de Terrassa
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TerrassaSpainUnknown status
Hospital Universitario de Torrejon
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Torrejón de ArdozSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.