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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Roche Diagnostics GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Small fetuses will be classified into 5 severity stages and managed as follows:
| |
| Study | Experimental | Doppler protocol (as in controls) + sFlt-1/PlGF ratio cutoffs will be incorporated as follows:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal and Neonatal complications | stillbirth, neonatal death, artery cord pH ≤7.0, respiratory distress syndrome, required invasive ventilatory support, grade III or IV intraventricular hemorrhage, neonatal sepsis, necrotizing enterocolitis, neonatal seizures, pneumonia, meningitis, broncopulmonary dysplasia, hypoxic ischemic encephalopathy, Apgar score <7 at 5 minutes, or elective delivery at <28 weeks of gestation. | During pregnancy and up to 28 days after delivery |
| Composite adverse maternal outcome | Progression to PE with severity features; progression to hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome (LDH >600 IU/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevated more than twice the upper limit of normal, and the platelet count less than 100 X 109/L); eclampsia, stroke, hepatic hematoma or rupture; oliguria (urine output of <400 mL during 24 hours, or need for treatment with furosemide to maintain urine output at >400 mL for 24 hours); cardiovascular dysfunction (need for inotropic support, left ventricle failure, or myocardial infarction); placental abruption; maternal death; maternal admission to intensive care unit >48 hours, and/or requirement for blood transfusion. | During pregnancy and up to 28 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal perceived stress | Mean and sd or median and IQR of the score obtained in the perceived stress scale in each group | At inclusion and 4 weeks later |
| Other perinatal outcomes | transient tachypnea, non-invasive ventilatory support, hypoglycemia, neonatal jaundice (treated with phototherapy), rate of elective deliveries < 30 weeks, <34 weeks and < 37 weeks for FGR and/or PE, birthweight <3 rd and <10th percentiles, mode of delivery (vaginal, instrumental vaginal delivery and Cesarean), rate of Cesarean delivery for abnormal CTG, median maternal stay in ICU, median neonatal stay in N-ICU, maternal corticosteroids (single dose, complete course), prenatal magnesium sulfate (at least 4h) for preterm delivery. |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manel Mendoza, MD, PhD | Contact | +34934893000 | 3085 | manel.mendoza@vallhebron.cat |
| Name | Affiliation | Role |
|---|---|---|
| Manel Mendoza, MD, PhD | Vall d'Hebron Institute Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de A Coruña | A Coruña | Spain |
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|
| During pregnancy and up to 28 days after delivery |
| Number of ultrasounds per participant | Mean and sd or median and IQR in each group | During pregnancy (before and after 37 weeks) |
| Hospital Universitario General de Alicante | Alicante | Spain |
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| Hospital Universitari Germans Trias i Pujol | Badalona | Spain |
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| Vall d'hebron Barcelona Hospital Campus | Barcelona | 08035 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
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| Hospital Universitari Dexeus | Barcelona | Spain |
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| Hospital Universitario Puerta del Mar | Cadiz | Spain |
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| Hospital General Universitario de Elche | Elche | Spain |
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| Hospital Universitario de Getafe | Getafe | Spain |
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| Hospital Universitario de Cabueñes | Gijón | Spain |
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| Hospital Universitari de Girona Doctor Josep Trueta | Girona | Spain |
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| Hospital Universitario San Cecilio | Granada | Spain |
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| Hospital Universitario de Jerez de la Frontera | Jerez de la Frontera | Spain |
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| Hospital Materno Infantil de Gran Canaria | Las Palmas de Gran Canaria | Spain |
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| Hospital Universitari Arnau de Vilanova | Lleida | Spain |
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| Hospital Clínico San Carlos | Madrid | Spain |
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| Hospital Universitari Son Espases | Palma de Mallorca | Spain |
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| Hospital Universitari Son Llàtzer | Palma de Mallorca | Spain |
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| Corporació Sanitària Parc Taulí | Sabadell | Spain |
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| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Spain |
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| Hospital Universitario Virgen de Valme | Seville | Spain |
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| Virgen Macarena | Seville | Spain |
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| Hospital Universitario Joan XXIII de Tarragona | Tarragona | Spain |
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| Consorci Sanitari de Terrassa | Terrassa | Spain |
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| Hospital Universitari Mútua Terrassa | Terrassa | Spain |
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| Hospital Universitario de Torrejón | Torrejón de Ardoz | Spain |
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| Hospital Clínico Universitario Lozano Blesa | Zaragoza | Spain |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D011225 | Pre-Eclampsia |
| D010922 | Placenta Diseases |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046110 | Hypertension, Pregnancy-Induced |
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