Preeclampsia Clinical Trial
— earlyGRAFDOfficial title:
Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler (Early GRAFD)
This is a multicentre, open-label, randomized controlled trial. A total of 598 singleton pregnancies with an EFW ≤10th percentile at <32+0 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 | Not yet recruiting |
Enrollment | 598 |
Est. completion date | January 30, 2025 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant women of at least 18 years old - Singleton pregnancy - Ultrasonographic EFW =10th percentile between 24+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 |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario de A Coruña | A Coruña | |
Spain | Hospital Universitario General de Alicante | Alicante | |
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitari Dexeus | Barcelona | |
Spain | Vall d'hebron Barcelona Hospital Campus | 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 Universitari Arnau de Vilanova | Lleida | |
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 | Sevilla | |
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 |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of severe perinatal complications | Preeclampsia with severity features, placental abruption, eclampsia, stillbirth, neonatal death, umbilical artery pH =7.0 | During pregnancy and up to 28 days after delivery | |
Primary | Composite adverse maternal outcome | Percentage of pregnancies with HELLP syndrome, severe PE, eclampsia, stroke, hepatic hematoma or rupture, oliguria, need for furosemide, cardiovascular dysfunction (inotropic support, myocardial infarction, left ventricle failure), placental abruption, maternal admission to intensive care unit >48h, and/or requirement for blood transfusion in each group. | During pregnancy and up to 28 days after delivery | |
Primary | Number of ultrasounds per participant | Mean and sd or median and IQR in each group | During pregnancy | |
Primary | Rate of elective deliveries <30 weeks | Percentage of deliveries indicated for FGR and/or PE <30 weeks | During pregnancy | |
Primary | Rate of elective deliveries <34 weeks | Percentage of deliveries indicated for FGR and/or PE <34 weeks | During pregnancy | |
Secondary | Maternal perceived stress | Mean and sd or median and IQR of the score obtained in the perceived stress scale in each group | During pregnancy | |
Secondary | Rate of elective deliveries <37 weeks | Percentage of deliveries indicated for FGR and/or PE <37 weeks | During pregnancy | |
Secondary | Composite adverse neonatal outcome | Percentage of neonates with Apgar score <7, umbilical artery pH =7.0, respiratory distress syndrome, transient tachypnea, required ventilatory support, grade III or IV intraventricular hemorrhage, neonatal sepsis, hypoglucemia, necrotizing enterocolitis, neonatal jaundice treated with phototherapy, neonatal seizures, pneumonia, meningitis and/or neonatal death. | During pregnancy and up to 28 days after delivery |
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