<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04502823</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AMI)527/2019</org_study_id>
    <nct_id>NCT04502823</nct_id>
  </id_info>
  <brief_title>Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler</brief_title>
  <acronym>GRAFD</acronym>
  <official_title>Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler (GRAFD Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open randomized non-inferiority controlled trial to examine the use of angiogenic factors&#xD;
      (instead of feto-placental Doppler) for fetal growth restriction at term to reduce the rate&#xD;
      of labor inductions, without worsening perinatal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant women with estimated fetal weight (EFW) &lt; 10th centile between 36+0 and 37+6 weeks&#xD;
      of gestation (WG) will receive complete ultrasonographic assessment consisting of&#xD;
      feto-placental Doppler, amniotic fluid measurement and biophysical profile assessment. The&#xD;
      cases not meeting any exclusion criteria will be offered to participate in this trial. After&#xD;
      giving their informed consent a blood sample will be drawn in all of them and they will&#xD;
      undergo randomization into two arms.&#xD;
&#xD;
        1. Intervention arm: In women allocated to the intervention group, the soluble fms-like&#xD;
           tyrosine kinase/placental growth factor (sFlt-1/PlGF) result will be revealed to the&#xD;
           investigators that will act according to the results of sFlt/PlGF:&#xD;
&#xD;
             -  Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended at ≥37 weeks.&#xD;
&#xD;
             -  Fetuses with sFlt-1/PlGF &lt;38, weekly follow up will be recommended until delivery&#xD;
                (at ≥40 weeks).&#xD;
&#xD;
        2. Control arm: In women allocated to the control group, the sFlt-1/PlGF result will be&#xD;
           blinded to caregivers. Routine Doppler-based clinical care will be used to counsel&#xD;
           women. Following the Doppler classification:&#xD;
&#xD;
             -  Fetuses with EFW below the 3rd centile or below the 10th centile accompanied by any&#xD;
                impaired fetoplacental Doppler, elective delivery will be recommended at at ≥37&#xD;
                weeks.&#xD;
&#xD;
             -  Fetuses with EFW above the 3rd centile without any fetoplacental Doppler&#xD;
                abnormality, elective delivery will be recommended at at ≥40 weeks.&#xD;
&#xD;
      In both arms, fetuses will receive weekly follow-up from randomization to delivery consisting&#xD;
      on feto-placental Doppler sFlt-1/PlGF and CTG. If any of the following is present at any&#xD;
      time, earlier delivery will be recommended:&#xD;
&#xD;
        -  sFlt-1/PlGF ≥38 (only in the intervention group),&#xD;
&#xD;
        -  absent or reverse end-diastolic flow at the umbilical artery Doppler or DV PI&gt;95th&#xD;
           centile&#xD;
&#xD;
        -  non-reassuring CTG&#xD;
&#xD;
        -  preeclampsia&#xD;
&#xD;
        -  diminished fetal movements&#xD;
&#xD;
        -  biophysical profile ≤ 6 or oligohydramnios (deepest pocket &lt;2 cm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse perinatal outcomes</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Cesarean delivery for non-reassuring fetal status or neonatal acidosis (artery cord potential of hydrogen (pH) &lt;7.15 + base excess &gt; -12 milliequivalent/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of elective delivery</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that required an elective delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Cesarean delivery</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that required a Cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Induction of labor</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that required an induction of labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of neonatal admission in intensive care unit</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of newborns that required admission in intensive care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of neonatal admission in intensive care unit</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Days in in intensive care of newborns that required admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of preeclampsia</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that developed preeclampsia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of neonatal complications</measure>
    <time_frame>4-10 weeks</time_frame>
    <description>Percentage of newborns with adverse outcomes (composite)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of maternal complications</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women with adverse outcomes (composite)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of perinatal complications</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of perinatal adverse outcomes (composite)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of total deliveries at &lt;37, &lt;38, &lt;39 and &lt;40 weeks of gestation</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that delivered at &lt;37, &lt;38, &lt;39 and &lt;40 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of elective deliveries at &lt;37, &lt;38, &lt;39 and &lt;40 weeks of gestation</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that delivered electively at &lt;37, &lt;38, &lt;39 and &lt;40 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of newborns with birthweight &lt;2000 and &lt;2500 grams</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Percentage of women that delivered a newborn with a birthweight &lt;2000 and &lt;2500 grams</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1030</enrollment>
  <condition>Fetal Growth Retardation</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinical practice: Management by Doppler and CTG findings.&#xD;
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:&#xD;
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.&#xD;
Fetuses with an EFW above the 3rd centile without any fetoplacental Doppler abnormality, elective delivery will be recommended at at ≥40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Management based on sFlt-1/PlGF values</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Management based on sFlt-1/PlGF values</intervention_name>
    <description>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:&#xD;
Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended immediately (within 24h) at ≥37 weeks.&#xD;
Fetuses with sFlt-1/PlGF &lt;38 weekly follow up will be recommended and delivery at ≥40 weeks.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women ≥ 16 years of age.&#xD;
&#xD;
          2. Singleton pregnancy.&#xD;
&#xD;
          3. Ultrasonographic estimated fetal weight &lt;10th centile.&#xD;
&#xD;
          4. Gestational age between 36+0 and 37+6 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Major fetal malformations or genetic disorders.&#xD;
&#xD;
          2. Fetal death.&#xD;
&#xD;
          3. Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI&gt;95th&#xD;
             centile.&#xD;
&#xD;
          4. Non-reassuring cardiotocography (CTG).&#xD;
&#xD;
          5. Preeclampsia.&#xD;
&#xD;
          6. Diminished fetal movements.&#xD;
&#xD;
          7. Biophysical profile ≤ 6.&#xD;
&#xD;
          8. Oligohydramnios&#xD;
&#xD;
          9. Refusal to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manel Mendoza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d'hebron Institut de Recerca</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manel Mendoza, PhD</last_name>
    <phone>0034934893000</phone>
    <phone_ext>3085</phone_ext>
    <email>mmendoza@vhebron.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de A Coruña</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nuria Valiño</last_name>
      <email>nuvalino@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General de Alicante</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Palacios</last_name>
      <email>ana.palacios.marques@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivan Hurtado</last_name>
      <email>ivan.hurtado85@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manel Mendoza</last_name>
      <email>mmendoza@vhebron.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Cabueñes</name>
      <address>
        <city>Cabueñes</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esther Perez</last_name>
      <email>estherpcarbajo@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta del Mar</name>
      <address>
        <city>Cadiz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Román Broullón</last_name>
      <email>joser.broullon.sspa@juntadeandalucia.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elena Moreno</last_name>
      <email>elenamorenoperez@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Getafe</name>
      <address>
        <city>Getafe</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonia Diaz</last_name>
      <email>drasony@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Doctor Josep Trueta</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Perez</last_name>
      <email>mperezdepuig@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Deu de Manresa</name>
      <address>
        <city>Manresa</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Alcoz</last_name>
      <email>marinalcoz@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Luisa Sanchez</last_name>
      <email>marisa00111@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Son Llàtzer</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Albert Tubau</last_name>
      <email>atubau68@icloud.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Consorci Corporació Sanitària Parc Taulí de Sabadell</name>
      <address>
        <city>Sabadell</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristina Lesmes</last_name>
      <email>cristinalesmesheredia@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Señora de Candelaria</name>
      <address>
        <city>Santa Cruz De Tenerife</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolina Chulilla</last_name>
      <email>cchulilla@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de Valme</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlota Borrero</last_name>
      <email>carlotaborrero@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Joan XXIII</name>
      <address>
        <city>Tarragona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lourdes Martin</last_name>
      <email>lourdesmartin3@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esperanza Garcia</last_name>
      <email>egarciac@cst.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Mútua Terrassa</name>
      <address>
        <city>Terrassa</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria del Mar Pallarols</last_name>
      <email>mpallarols@mutuaterrassa.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Torrejon</name>
      <address>
        <city>Torrejón De Ardoz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene Fernandez</last_name>
      <email>ibuhigas80@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Ibañez</last_name>
      <email>patribanez@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>December 20, 2021</last_update_submitted>
  <last_update_submitted_qc>December 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04502823
org study id: PR(AMI)527/2019
nct id: NCT04502823
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse perinatal outcomes
time frame: 4-6 weeks
description: Cesarean delivery for non-reassuring fetal status or neonatal acidosis (artery cord potential of hydrogen (pH) <7.15 + base excess > -12 milliequivalent/L)
measure: Rate of elective delivery
time frame: 4-6 weeks
description: Percentage of women that required an elective delivery
measure: Rate of Cesarean delivery
time frame: 4-6 weeks
description: Percentage of women that required a Cesarean delivery
measure: Rate of Induction of labor
time frame: 4-6 weeks
description: Percentage of women that required an induction of labor
measure: Rate of neonatal admission in intensive care unit
time frame: 4-6 weeks
description: Percentage of newborns that required admission in intensive care
measure: Time of neonatal admission in intensive care unit
time frame: 4-6 weeks
description: Days in in intensive care of newborns that required admission
measure: Rate of preeclampsia
time frame: 4-6 weeks
description: Percentage of women that developed preeclampsia
measure: Rate of neonatal complications
time frame: 4-10 weeks
description: Percentage of newborns with adverse outcomes (composite)
measure: Rate of maternal complications
time frame: 4-6 weeks
description: Percentage of women with adverse outcomes (composite)
measure: Rate of perinatal complications
time frame: 4-6 weeks
description: Percentage of perinatal adverse outcomes (composite)
measure: Rate of total deliveries at <37, <38, <39 and <40 weeks of gestation
time frame: 4-6 weeks
description: Percentage of women that delivered at <37, <38, <39 and <40 weeks of gestation
measure: Rate of elective deliveries at <37, <38, <39 and <40 weeks of gestation
time frame: 4-6 weeks
description: Percentage of women that delivered electively at <37, <38, <39 and <40 weeks of gestation
measure: Rate of newborns with birthweight <2000 and <2500 grams
time frame: 4-6 weeks
description: Percentage of women that delivered a newborn with a birthweight <2000 and <2500 grams
arm group label: Control Group
arm group type: No Intervention
description: 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.
arm group label: Intervention Group
arm group type: Experimental
description: Management based on sFlt-1/PlGF values
intervention type: Procedure
intervention name: Management based on sFlt-1/PlGF values
description: 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.
arm group label: Intervention Group
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Manel Mendoza, PhD
role: Principal Investigator
affiliation: Vall d'hebron Institut de Recerca
last name: Manel Mendoza, PhD
phone: 0034934893000
phone ext: 3085
email: mmendoza@vhebron.net
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country: Spain
responsible party type: Sponsor
mesh term: Fetal Growth Retardation