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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04502823
Other study ID # PR(AMI)527/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2020
Est. completion date December 18, 2022

Study information

Verified date July 2021
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Pregnant women with estimated fetal weight (EFW) < 10th centile between 36+0 and 37+6 weeks of gestation (WG) will receive complete ultrasonographic assessment consisting of feto-placental Doppler, amniotic fluid measurement and biophysical profile assessment. The cases not meeting any exclusion criteria will be offered to participate in this trial. After giving their informed consent a blood sample will be drawn in all of them and they will undergo randomization into two arms. 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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

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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