<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/NCT01661439</url>
  </required_header>
  <id_info>
    <org_study_id>PCTRPL</org_study_id>
    <secondary_id>preconceptional heparin in APS</secondary_id>
    <nct_id>NCT01661439</nct_id>
  </id_info>
  <brief_title>Preconceptional Thromboprophylaxis in Recurrent PREGNANCY LOSSES Caused by Antiphospholipid Syndrome</brief_title>
  <official_title>A Randomized Clinical Trial of Using Preconceptional Enoxaparin AND Low Dose Aspirin 81mg in Patient With Antiphospholipid Syndrome(APS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preconceptional use of low molecular weight heparin (enoxaparin) and aspirin in patient with&#xD;
      recurrent miscarriages with positive anti phospholipid antibodies increase the implantation&#xD;
      rate and the duration of pregnancy with low complications to the mother and the baby.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preconceptional heparin during follicular or luteal phase,improves the implantation rate by&#xD;
      increasing the blood flow and increasing the implantation factors,also decreasing the&#xD;
      pregnancy complication resulting from Antiphospholipid Syndrome (APS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy continuation beyond twelve weeks gestation</measure>
    <time_frame>ONE YEAR</time_frame>
    <description>giving low molecular weight heparin (enoxaparin) and 81 mg aspirin in patients with positive anti phospholipid antibodies with history of recurrent miscarriages or intrauterine fetal deaths in the preconceptional period one month before pregnancy with follow up as regarding the clinical pregnancy rate,the rate of continuation of pregnancy beyond 28 weeks gestation and the complications related to long term use of heparin and the severity of complication of APS in comparison to the traditional use of anticoagulant after documentation of the fetal heart rate</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">316</enrollment>
  <condition>Recurrent Pregnancy Losses</condition>
  <condition>Positive Anti Phospholipid Syndrome</condition>
  <arm_group>
    <arm_group_label>Low molecular weight heparin</arm_group_label>
    <description>SC LMWH IN patients with recurrent pregnancy loss</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low molecular weight heparin (enoxeparine)</intervention_name>
    <description>1mg/kg enoxeparine SC daily from 1st day of the menstrual cycle and continue daily throughout the pregnancy after documentation of pregnancy,and stopped in absence of fetal cardiac activity.</description>
    <arm_group_label>Low molecular weight heparin</arm_group_label>
    <other_name>clexane,innohep</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with recurrent pregnancy losses either two or more recurrent miscarriages or&#xD;
        intrauterine fetal deathes after 20 weeks of gestation with positive antiphospholipid&#xD;
        antibodies in medium to high titer in two occasions 6 weeks apart.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All women with recurrent first-trimester miscarriage and all women with one or more&#xD;
             second-trimester miscarriage who screened before pregnancy for antiphospholipid&#xD;
             antibodies.&#xD;
&#xD;
          2. To diagnose antiphospholipid syndrome it is mandatory that the woman has two positive&#xD;
             tests at least 12 weeks apart for either lupus anticoagulant or anticardiolipin&#xD;
             antibodies of immunoglobulin G and/or immunoglobulin M class present in a medium or&#xD;
             high titre over 40 g/l or ml/l,or above the 99th percentile).&#xD;
&#xD;
        In the detection of lupus anticoagulant, the dilute Russell's viper venom time test&#xD;
        together with a platelet neutralisation procedure is more sensitive and specific than&#xD;
        either the activated partial thromboplastin time test or the kaolin clotting time test.&#xD;
        Anticardiolipin antibodies are detected using a standardised enzyme linked immunosorbent&#xD;
        assay.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age above forty years old .&#xD;
&#xD;
          2. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography,&#xD;
             hysterosalpingogram, or hysteroscopy).&#xD;
&#xD;
          3. Fibroids distorting uterine cavity .&#xD;
&#xD;
          4. Abnormal parental karyotype .&#xD;
&#xD;
          5. Other identifiable causes of recurrent miscarriages (tests initiated only if&#xD;
             clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus&#xD;
             (SLE).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alaa Mahmoud Ismail, M.D</last_name>
    <phone>+201000459514</phone>
    <email>dr.alaa_ismail@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hassan salah Kamel, M.D</last_name>
    <phone>+201006623455</phone>
    <email>hkamelhkamel@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Women Health Hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HASSAN S KAMEL, MD</last_name>
      <phone>+2010066436</phone>
      <email>hkamelhkamel@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Alaa M Ismail, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2012</verification_date>
  <study_first_submitted>July 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>June 20, 2014</last_update_submitted>
  <last_update_submitted_qc>June 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>alaa eldeen mahmoud ismail</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Recurrent miscarriages</keyword>
  <keyword>recurrent pregnancy loss</keyword>
  <keyword>aps</keyword>
  <keyword>anti coagulants in pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Fetal Death</mesh_term>
    <mesh_term>Abortion, Habitual</mesh_term>
    <mesh_term>Antiphospholipid Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</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/NCT01661439
org study id: PCTRPL
secondary id: preconceptional heparin in APS
nct id: NCT01661439
lead sponsor: 
has dmc: Yes
Preconceptional use of low molecular weight heparin (enoxaparin) and aspirin in patient with
      recurrent miscarriages with positive anti phospholipid antibodies increase the implantation
      rate and the duration of pregnancy with low complications to the mother and the baby.
Preconceptional heparin during follicular or luteal phase,improves the implantation rate by
      increasing the blood flow and increasing the implantation factors,also decreasing the
      pregnancy complication resulting from Antiphospholipid Syndrome (APS).
observational model: Cohort
time perspective: Prospective
measure: Pregnancy continuation beyond twelve weeks gestation
time frame: ONE YEAR
description: giving low molecular weight heparin (enoxaparin) and 81 mg aspirin in patients with positive anti phospholipid antibodies with history of recurrent miscarriages or intrauterine fetal deaths in the preconceptional period one month before pregnancy with follow up as regarding the clinical pregnancy rate,the rate of continuation of pregnancy beyond 28 weeks gestation and the complications related to long term use of heparin and the severity of complication of APS in comparison to the traditional use of anticoagulant after documentation of the fetal heart rate
arm group label: Low molecular weight heparin
description: SC LMWH IN patients with recurrent pregnancy loss
intervention type: Drug
intervention name: low molecular weight heparin (enoxeparine)
description: 1mg/kg enoxeparine SC daily from 1st day of the menstrual cycle and continue daily throughout the pregnancy after documentation of pregnancy,and stopped in absence of fetal cardiac activity.
arm group label: Low molecular weight heparin
other name: clexane,innohep
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alaa Mahmoud Ismail, M.D
phone: +201000459514
email: dr.alaa_ismail@yahoo.com
last name: Hassan salah Kamel, M.D
phone: +201006623455
email: hkamelhkamel@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: alaa eldeen mahmoud ismail
investigator title: MD
mesh term: Abortion, Spontaneous
mesh term: Fetal Death
mesh term: Abortion, Habitual
mesh term: Antiphospholipid Syndrome
mesh term: Syndrome
mesh term: Recurrence
mesh term: Heparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin