Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler
NCT ID: NCT04502823
Last Updated: 2024-02-21
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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COMPLETED
NA
1088 participants
INTERVENTIONAL
2020-09-21
2022-12-18
Brief Summary
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Detailed Description
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1. Intervention arm: In women allocated to the intervention group, the soluble fms-like tyrosine kinase/placental growth factor (sFlt-1/PlGF) result will be revealed to the investigators that will act according to the results of sFlt/PlGF:
* Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended at ≥37 weeks.
* Fetuses with sFlt-1/PlGF \<38, weekly follow up will be recommended until delivery (at ≥40 weeks).
2. Control arm: In women allocated to the control group, the sFlt-1/PlGF result will be blinded to caregivers. Routine Doppler-based clinical care will be used to counsel women. Following the Doppler classification:
* Fetuses with EFW below the 3rd centile or below the 10th centile accompanied by any impaired fetoplacental Doppler, elective delivery will be recommended at at ≥37 weeks.
* Fetuses with EFW above the 3rd centile without any fetoplacental Doppler abnormality, elective delivery will be recommended at at ≥40 weeks.
In both arms, fetuses will receive weekly follow-up from randomization to delivery consisting on feto-placental Doppler sFlt-1/PlGF and CTG. If any of the following is present at any time, earlier delivery will be recommended:
* sFlt-1/PlGF ≥38 (only in the intervention group),
* absent or reverse end-diastolic flow at the umbilical artery Doppler or DV PI\>95th centile
* non-reassuring CTG
* preeclampsia
* diminished fetal movements
* biophysical profile ≤ 6 or oligohydramnios (deepest pocket \<2 cm).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Clinical practice: Management by Doppler and CTG findings.
In women allocated to the control group, the sFlt-1/PlGF result will be blinded to caregivers. Routine Doppler-based clinical care will be used to counsel women. Following the Doppler classification:
* Fetuses with an EFW below the 3rd centile or below the 10th centile accompanied by any impaired fetoplacental Doppler, elective delivery will be recommended immediately (within 24h) at ≥37 weeks.
* Fetuses with an EFW above the 3rd centile without any fetoplacental Doppler abnormality, elective delivery will be recommended at at ≥40 weeks.
No interventions assigned to this group
Intervention Group
Management based on sFlt-1/PlGF values
Management based on sFlt-1/PlGF values
In women allocated to the intervention group, the sFlt-1/PlGF result will be revealed to the investigators that will act according to the results of sFlt/PlGF:
* Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended immediately (within 24h) at ≥37 weeks.
* Fetuses with sFlt-1/PlGF \<38 weekly follow up will be recommended and delivery at ≥40 weeks.
Interventions
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Management based on sFlt-1/PlGF values
In women allocated to the intervention group, the sFlt-1/PlGF result will be revealed to the investigators that will act according to the results of sFlt/PlGF:
* Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended immediately (within 24h) at ≥37 weeks.
* Fetuses with sFlt-1/PlGF \<38 weekly follow up will be recommended and delivery at ≥40 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Singleton pregnancy.
3. Ultrasonographic estimated fetal weight \<10th centile.
4. Gestational age between 36+0 and 37+6 weeks.
Exclusion Criteria
2. Fetal death.
3. Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI\>95th centile.
4. Non-reassuring cardiotocography (CTG).
5. Preeclampsia.
6. Diminished fetal movements.
7. Biophysical profile ≤ 6.
8. Oligohydramnios
9. Refusal to give informed consent.
16 Years
FEMALE
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Manel Mendoza, PhD
Role: PRINCIPAL_INVESTIGATOR
Vall d'hebron Institut de Recerca
Locations
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Hospital Universitario de A Coruña
A Coruña, , Spain
Hospital General de Alicante
Alicante, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitari Vall d'hebron
Barcelona, , Spain
Hospital Universitario de Cabueñes
Cabueñes, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Universitario de Getafe
Getafe, , Spain
Hospital Universitari Doctor Josep Trueta
Girona, , Spain
Hospital Sant Joan de Deu de Manresa
Manresa, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Son Llàtzer
Palma de Mallorca, , Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Universitari Joan XXIII
Tarragona, , Spain
Hospital de Terrassa
Terrassa, , Spain
Hospital Universitari Mútua Terrassa
Terrassa, , Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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References
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Garcia-Manau P, Bonacina E, Martin-Alonso R, Martin L, Palacios A, Sanchez-Camps ML, Lesmes C, Hurtado I, Perez E, Tubau A, Ibanez P, Alcoz M, Valino N, Moreno E, Borrero C, Garcia E, Lopez-Quesada E, Diaz S, Broullon JR, Teixidor M, Chulilla C, Ferrer-Costa R, Gil MM, Lopez M, Ramos-Forner GM, Blanco JE, Moreno A, Lazaro-Rodriguez M, Vaquerizo O, Soriano B, Fabre M, Gomez-Valencia E, Cuina A, Alayon N, Sainz-Bueno JA, Vives A, Esteve E, Ocana V, Lopez MA, Maroto A, Carreras E, Mendoza M. Angiogenic factors versus fetomaternal Doppler for fetal growth restriction at term: an open-label, randomized controlled trial. Nat Med. 2025 Mar;31(3):1008-1015. doi: 10.1038/s41591-024-03421-9. Epub 2025 Jan 7.
Garcia-Manau P, Mendoza M, Bonacina E, Martin-Alonso R, Martin L, Palacios A, Sanchez ML, Lesmes C, Hurtado I, Perez E, Tubau A, Ibanez P, Alcoz M, Valino N, Moreno E, Borrero C, Garcia E, Lopez-Quesada E, Diaz S, Broullon JR, Teixidor M, Chulilla C, Gil MM, Lopez M, Candela-Hidalgo A, Salinas-Amoros A, Moreno A, Morra F, Vaquerizo O, Soriano B, Fabre M, Gomez-Valencia E, Cuina A, Alayon N, Sainz JA, Vives A, Esteve E, Ocana V, Lopez MA, Maroto A, Carreras E. The Fetal Growth Restriction at Term Managed by Angiogenic Factors Versus Feto-Maternal Doppler (GRAFD) Trial to Avoid Adverse Perinatal Outcomes: Protocol for a Multicenter, Open-Label, Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 11;11(10):e37452. doi: 10.2196/37452.
Other Identifiers
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PR(AMI)527/2019
Identifier Type: -
Identifier Source: org_study_id
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