Fetal Growth Retardation Clinical Trial
— GRAFDOfficial title:
Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler (GRAFD Trial)
Verified date | July 2021 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Open randomized non-inferiority controlled trial to examine the use of angiogenic factors (instead of feto-placental Doppler) for fetal growth restriction at term to reduce the rate of labor inductions, without worsening perinatal outcomes.
Status | Completed |
Enrollment | 1088 |
Est. completion date | December 18, 2022 |
Est. primary completion date | December 18, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: 1. Pregnant women = 16 years of age. 2. Singleton pregnancy. 3. Ultrasonographic estimated fetal weight <10th centile. 4. Gestational age between 36+0 and 37+6 weeks. Exclusion Criteria: 1. Major fetal malformations or genetic disorders. 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. |
Country | Name | City | State |
---|---|---|---|
Spain | 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 | Sevilla | |
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 |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse perinatal outcomes | Cesarean delivery for non-reassuring fetal status or neonatal acidosis (artery cord potential of hydrogen (pH) <7.15 + base excess > -12 milliequivalent/L) | 4-6 weeks | |
Secondary | Rate of elective delivery | Percentage of women that required an elective delivery | 4-6 weeks | |
Secondary | Rate of Cesarean delivery | Percentage of women that required a Cesarean delivery | 4-6 weeks | |
Secondary | Rate of Induction of labor | Percentage of women that required an induction of labor | 4-6 weeks | |
Secondary | Rate of neonatal admission in intensive care unit | Percentage of newborns that required admission in intensive care | 4-6 weeks | |
Secondary | Time of neonatal admission in intensive care unit | Days in in intensive care of newborns that required admission | 4-6 weeks | |
Secondary | Rate of preeclampsia | Percentage of women that developed preeclampsia | 4-6 weeks | |
Secondary | Rate of neonatal complications | Percentage of newborns with adverse outcomes (composite) | 4-10 weeks | |
Secondary | Rate of maternal complications | Percentage of women with adverse outcomes (composite) | 4-6 weeks | |
Secondary | Rate of perinatal complications | Percentage of perinatal adverse outcomes (composite) | 4-6 weeks | |
Secondary | Rate of total deliveries at <37, <38, <39 and <40 weeks of gestation | Percentage of women that delivered at <37, <38, <39 and <40 weeks of gestation | 4-6 weeks | |
Secondary | Rate of elective deliveries at <37, <38, <39 and <40 weeks of gestation | Percentage of women that delivered electively at <37, <38, <39 and <40 weeks of gestation | 4-6 weeks | |
Secondary | Rate of newborns with birthweight <2000 and <2500 grams | Percentage of women that delivered a newborn with a birthweight <2000 and <2500 grams | 4-6 weeks |
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