Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler
NCT ID: NCT05284474
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
340 participants
INTERVENTIONAL
2024-06-03
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control
Small fetuses will be classified into 5 severity stages and managed as follows:
* SGA: Estimated fetal weight (EFW) between p3 and p10 with normal Dopplers. Ultrasound/2 weeks, elective vaginal delivery at ≥39-40 weeks.
* Stage I: EFW ≤p3 p or EFW p3-10 + UA PI \>p95 and/or UtA PI \>p95, and, at ≥32 weeks, CPR and/or MCA PI \<p5, in 2 occasions \>12 hours apart. Ultrasound weekly, elective vaginal delivery at ≥37 weeks.
* Stage II: AEDF UA in 2 occasions \>12 hours apart. Ultrasound every 48-72h, elective Cesarean delivery at ≥34 weeks.
* Stage III: DV PI \> p95 (or absent DV "a" wave) or reversed end-diastolic UA \>50% of cycles, in both cases in two occasions \> 6 hours apart. Ultrasound every 24-48h, elective Cesarean delivery at ≥30 weeks.
* Stage IV: reversed DV "a" wave in two occasions \> 6 hours apart. Elective Cesarean delivery at ≥26 weeks.
No interventions assigned to this group
Study
Doppler protocol (as in controls) + sFlt-1/PlGF ratio cutoffs will be incorporated as follows:
* \<38: Ultrasound biweekly in stage I FGR and every four weeks in SGA. In both cases delivery at ≥39-40 weeks.
* 38-110: In stage I FGR and SGA ultrasound weekly. Delivery at ≥37 weeks.
* \>110: In stage I FGR and SGA ultrasound weekly. Delivery at ≥36 weeks.
* \>110 and concurrent preeclampsia: In stage I FGR and SGA ultrasound every 48h-72h. Delivery at ≥34 weeks.
* \>201: Ultrasound every 48-72h, delivery at ≥34+0 weeks. If concurrent preeclampsia, delivery at ≥32+0 weeks.
* \>655: Ultrasound every 48-72h, delivery at ≥32+0 weeks. If concurrent preeclampsia, delivery at ≥30+0 weeks.
* \>1000: In cases with concurrent PE, delivery at ≥29+0 weeks.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Fetal death
* Refusal to give informed consent
* Stage IV FGR
18 Years
FEMALE
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Roche Diagnostics GmbH
INDUSTRY
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Manel Mendoza, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron Institut de Recerca (VHIR)
Locations
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Complejo Hospitalario Universitario de A Coruña
A Coruña, , Spain
Hospital Universitario General de Alicante
Alicante, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Vall d'hebron Barcelona Hospital Campus
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Dexeus
Barcelona, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Universitario de Getafe
Getafe, , Spain
Hospital Universitario de Cabueñes
Gijón, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitari Son Llàtzer
Palma de Mallorca, , Spain
Corporació Sanitària Parc Taulí
Sabadell, , Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Virgen Macarena
Seville, , Spain
Hospital Universitario Joan XXIII de Tarragona
Tarragona, , Spain
Consorci Sanitari de Terrassa
Terrassa, , Spain
Hospital Universitari Mútua Terrassa
Terrassa, , Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR(AMI)113/2022
Identifier Type: -
Identifier Source: org_study_id
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