<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/NCT03230162</url>
  </required_header>
  <id_info>
    <org_study_id>Ain shams university maternity</org_study_id>
    <nct_id>NCT03230162</nct_id>
  </id_info>
  <brief_title>Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment</brief_title>
  <official_title>Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due&#xD;
      to placental insufficiency&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred pregnant women with documented intrauterine growth restriction due to placental&#xD;
      insufficiency at 28-35 weeks of gestation will be distributed into two groups:&#xD;
&#xD;
        -  Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily.&#xD;
&#xD;
        -  Group H: 50 women will receive single dose of LMWH subcutaneous daily.&#xD;
&#xD;
      Both groups will undergo strict fetal surveillance in the form of:&#xD;
&#xD;
      Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus:&#xD;
&#xD;
      middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket&#xD;
      (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2018</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal birth weight in grams</measure>
    <time_frame>At time of Delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in Doppler velocity indices,</measure>
    <time_frame>24 week till 35 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal growth velocity</measure>
    <time_frame>weekly till time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age at delivery,</measure>
    <time_frame>at time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>at 1 and 5 min of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal complication rates</measure>
    <time_frame>The first 28 day of delivery</time_frame>
    <description>respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal ICU admission rate</measure>
    <time_frame>The first 28 day of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the interval between the diagnosis and delivery</measure>
    <time_frame>at time of delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fetal Growth Abnormality</condition>
  <condition>Fetal Growth Restriction</condition>
  <arm_group>
    <arm_group_label>sildenafil citrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low molecular weight heparin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow &lt; 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily &gt; 170 kg 75 u/kg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil</intervention_name>
    <description>sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery</description>
    <arm_group_label>sildenafil citrate</arm_group_label>
    <other_name>Silden EIPICO co.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>low molecular weight heparin</intervention_name>
    <description>a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery</description>
    <arm_group_label>low molecular weight heparin</arm_group_label>
    <other_name>tinzaparin</other_name>
    <other_name>Innohep LEO pharmaceutical products</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maternal age between 20-35 years.&#xD;
&#xD;
          -  Being at a gestational age 28-35wks.&#xD;
&#xD;
          -  Singleton pregnancy.&#xD;
&#xD;
          -  Fetal growth restriction diagnosed by ultrasound with estimated fetal weight below the&#xD;
             10th percentile, and/or fetal abdominal circumference at or below the tenth&#xD;
             percentile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maternal age less than 20 years or more than 35 years.&#xD;
&#xD;
          -  Undetermined gestational age.&#xD;
&#xD;
          -  Multiple gestation.&#xD;
&#xD;
          -  Chronic diseases with pregnancy e.g. Chronic hypertension, diabetes type 1 or 2.&#xD;
&#xD;
          -  Etiologies of FGR other than placental insufficiency as fetal malformations,&#xD;
             aneuploidy or infections.&#xD;
&#xD;
          -  Suspected fetal compromise requiring emergency delivery.&#xD;
&#xD;
          -  Any contraindication to the use of sildenafil e.g. known significant maternal cardiac&#xD;
             disease, left ventricular outflow tract obstruction, concomitant treatment with&#xD;
             nitrates or previous allergy to sildenafil.&#xD;
&#xD;
          -  Any contraindication to the use of LMWH e.g. known bleeding disorder, active antenatal&#xD;
             bleeding or at increased risk of major hemorrhage (e.g. placenta praevia),&#xD;
             thrombocytopenia, severe renal or hepatic disease.&#xD;
&#xD;
          -  Drug or alcohol abuse.&#xD;
&#xD;
          -  Patient refusing to participate in the study or unable to consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Radwa R Ali, MD</last_name>
    <phone>01283492979</phone>
    <phone_ext>+202</phone_ext>
    <email>radwaebed@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>AinShams university maternity hospital</name>
      <address>
        <city>Cairo</city>
        <zip>02</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radwa R Ali, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>May 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 23, 2017</last_update_submitted>
  <last_update_submitted_qc>July 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>lecturer of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</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>
    <mesh_term>Sildenafil Citrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03230162
org study id: Ain shams university maternity
nct id: NCT03230162
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
comparing the effect of using sildenafil citrate and LMWH in treatment of cases of IUGR due
      to placental insufficiency
One hundred pregnant women with documented intrauterine growth restriction due to placental
      insufficiency at 28-35 weeks of gestation will be distributed into two groups:

        -  Group S: 50 women will receive Sildenafil citrate 25 mg tab 3 times daily.

        -  Group H: 50 women will receive single dose of LMWH subcutaneous daily.

      Both groups will undergo strict fetal surveillance in the form of:

      Umbilical artery Doppler (UAD) is the primary surveillance tool in the FGR fetus:

      middle cerebral artery (MCA) Doppler, ultrasound for (AC, EFW, and deepest vertical pocket
      (DVP) for amniotic fluid) and non stress test and Biophysical profile (BPP)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Neonatal birth weight in grams
time frame: At time of Delivery
measure: The change in Doppler velocity indices,
time frame: 24 week till 35 weeks
measure: Fetal growth velocity
time frame: weekly till time of delivery
measure: Gestational age at delivery,
time frame: at time of delivery
measure: APGAR score
time frame: at 1 and 5 min of life
measure: Neonatal complication rates
time frame: The first 28 day of delivery
description: respiratory distress syndrome, intraventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal anemia, and neonatal blood transfusion
measure: Neonatal ICU admission rate
time frame: The first 28 day of delivery
measure: the interval between the diagnosis and delivery
time frame: at time of delivery
arm group label: sildenafil citrate
arm group type: Experimental
description: 50 pregnant female will be treated with sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery.
arm group label: low molecular weight heparin
arm group type: Experimental
description: 50 pregnant female will be treated with a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery according to body weight as follow < 50 kg 3500 units daily 50-90 kg 4500 units daily 91-130 kg 7000 units daily 131-170 kg 9000 units daily > 170 kg 75 u/kg/day
intervention type: Drug
intervention name: Sildenafil
description: sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
arm group label: sildenafil citrate
other name: Silden EIPICO co.
intervention type: Drug
intervention name: low molecular weight heparin
description: a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
arm group label: low molecular weight heparin
other name: tinzaparin
other name: Innohep LEO pharmaceutical products
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Radwa R Ali, MD
phone: 01283492979
phone ext: +202
email: radwaebed@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: lecturer of obstetrics and gynecology
mesh term: Fetal Growth Retardation
mesh term: Heparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin
mesh term: Sildenafil Citrate
sharing ipd: Undecided