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
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario Universitario de A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario General de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Vall d'Hebron Barcelona Hospital Campus Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Dexeus Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital Universitario de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Unknown status |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital Universitari de Girona Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitario San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario de Jerez de La Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| Hospital Materno Infantil de Gran Canaria Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Universitari Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitari Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitari Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Corporacio Sanitaria Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Virgen de Valme Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Joan XXIII de Tarragona Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Consorci Sanitari de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hospital Universitario de Torrejon Coordinator of this site? Confirm its status | Torrejón de Ardoz | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.