<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/NCT01729468</url>
  </required_header>
  <id_info>
    <org_study_id>PHRN08-FP/PERASTUN</org_study_id>
    <secondary_id>2011-003536-30</secondary_id>
    <secondary_id>2012-R8</secondary_id>
    <secondary_id>A120316-72</secondary_id>
    <secondary_id>912140</secondary_id>
    <nct_id>NCT01729468</nct_id>
  </id_info>
  <brief_title>Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers</brief_title>
  <acronym>PERASTUN</acronym>
  <official_title>Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given&#xD;
      bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous&#xD;
      pregnant women selected as &quot;high-risk&quot; by the presence of a bilateral uterine artery notch&#xD;
      and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6&#xD;
      weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2012</start_date>
  <completion_date type="Actual">October 25, 2016</completion_date>
  <primary_completion_date type="Actual">October 25, 2016</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)</measure>
    <time_frame>women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Small for gestational age at birth (≤5th percentile on customized growth curves)</measure>
    <time_frame>women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks</measure>
    <time_frame>women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe pre-eclampsia (ACOG criteria)</measure>
    <time_frame>women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perinatal death (22 weeks of gestation to 7 days postnatal)</measure>
    <time_frame>women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-eclampsia (ACOG criteria)</measure>
    <time_frame>women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of treatment</measure>
    <time_frame>women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Mode of delivery (vaginal or cesarean)</measure>
    <time_frame>women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mode of anesthesia for delivery</measure>
    <time_frame>women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1106</enrollment>
  <condition>Pre-eclampsia</condition>
  <condition>Intra-uterine Growth Restriction</condition>
  <arm_group>
    <arm_group_label>Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aspirin 160 mg per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 160 mg per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Aspirin, 160 mg per day until 34 weeks of gestation</description>
    <arm_group_label>Aspirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, 160 mg per day until 34 weeks of gestation</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Nulliparous (no previous pregnancy ≥ 22 SA)&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Gestational age ≤ 15 +6 weeks&#xD;
&#xD;
          -  Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7&#xD;
             during first trimester ultrasound (CRL between 45 and 84 mm)&#xD;
&#xD;
          -  Maternal informed consent obtained&#xD;
&#xD;
          -  Affiliated to social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women considering voluntary pregnancy termination (≤ 14 weeks)&#xD;
&#xD;
          -  Pre-existing (maternal) indication for premature delivery before 37 weeks&#xD;
&#xD;
          -  Fetal condition detected during the first trimester scan (fetal malformation or nuchal&#xD;
             translucency ≥ 95th percentile)&#xD;
&#xD;
          -  Women under anticoagulation&#xD;
&#xD;
          -  Allergy or hypersensitivity to Kardegic® or one of its constituents&#xD;
&#xD;
          -  Secondary hemostasis disorder responsible for bleeding or risk of bleeding&#xD;
&#xD;
          -  Peptic ulcer under evolution&#xD;
&#xD;
          -  Lupus or antiphospholipid syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franck PERROTIN, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique, Polyclinique du PARC</name>
      <address>
        <city>Caen</city>
        <zip>14052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Mosaïque Santé</name>
      <address>
        <city>La Chaussée St Victor</city>
        <zip>41260</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique, CHR Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique, Polyclinique de l'Atlantique</name>
      <address>
        <city>Nantes</city>
        <zip>44819</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45032</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France</name>
      <address>
        <city>Fort de France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Martinique</country>
  </location_countries>
  <reference>
    <citation>Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.</citation>
    <PMID>22986844</PMID>
  </reference>
  <reference>
    <citation>Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.</citation>
    <PMID>23004922</PMID>
  </reference>
  <reference>
    <citation>Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.</citation>
    <PMID>18634131</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Dose Acetylsalicylic Acid</keyword>
  <keyword>Prevention</keyword>
  <keyword>Pre-eclampsia</keyword>
  <keyword>Intra-uterine Growth Restriction</keyword>
  <keyword>Primiparous Women</keyword>
  <keyword>Bilateral Uterine Artery Notches</keyword>
  <keyword>First Quarter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Fetal Growth Retardation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_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/NCT01729468
org study id: PHRN08-FP/PERASTUN
secondary id: 2011-003536-30
secondary id: 2012-R8
secondary id: A120316-72
secondary id: 912140
nct id: NCT01729468
lead sponsor: 
has dmc: Yes
The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given
      bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous
      pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch
      and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6
      weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Small for gestational age at birth (≤5th percentile on customized growth curves)
time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
measure: Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Severe pre-eclampsia (ACOG criteria)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Perinatal death (22 weeks of gestation to 7 days postnatal)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Pre-eclampsia (ACOG criteria)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Adverse effects of treatment
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
measure: Mode of delivery (vaginal or cesarean)
time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
measure: Mode of anesthesia for delivery
time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
arm group label: Aspirin
arm group type: Experimental
description: Aspirin 160 mg per day
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 160 mg per day
intervention type: Drug
intervention name: Aspirin
description: Aspirin, 160 mg per day until 34 weeks of gestation
arm group label: Aspirin
intervention type: Drug
intervention name: Placebo
description: Placebo, 160 mg per day until 34 weeks of gestation
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Months
maximum age: N/A
healthy volunteers: No
last name: Franck PERROTIN, MD-PhD
role: Principal Investigator
affiliation: University Hospital, Tours
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Martinique
citation: Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.
PMID: 22986844
citation: Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.
PMID: 23004922
citation: Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.
PMID: 18634131
responsible party type: Sponsor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Fetal Growth Retardation
mesh term: Aspirin