<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/NCT01674127</url>
  </required_header>
  <id_info>
    <org_study_id>390306</org_study_id>
    <nct_id>NCT01674127</nct_id>
  </id_info>
  <brief_title>Effect of Methyldopa on Uterine Artery Diameter in Pregnant Women With Mild Preeclampsia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      The present study examined the effects of Methyldopa on uterine artery diameter, uterine&#xD;
      artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with&#xD;
      Preeclampsia, using Doppler ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Doppler indices</measure>
    <time_frame>7 days</time_frame>
    <description>In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days.Before and after drug use, Doppler ultrasound test was done by a radiology specialist not informed of patients grouping. Also, pulsatility index, resistance index, systolic/diastolic blood flow ratios of uterine artery, umbilical artery and middle-cerebral artery were evaluated. Registered for all patients, age, BMI, gestational week and the number of pregnancies were among other examined variables.&#xD;
Doppler indices of examined arteries in studied groups were evaluated by color Doppler ultrasound of model &quot;Hitachi 3/6 MHz&quot;.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pregnant Women With Mild Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Methyldopa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methyldopa</intervention_name>
    <arm_group_label>Methyldopa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        They met the inclusion criteria, If they had over 25 weeks of gestational age, no history&#xD;
        of chronic hypertension, no diabetes mellitus, no chronic systemic diseases, no collagen&#xD;
        vascular diseases and antiphospholipid syndromes, no use of antihypertensive drugs and BMI&#xD;
        higher than 19 and lower than 30 (kg/m2).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mojtaba Akbari</investigator_full_name>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyldopa</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/NCT01674127
org study id: 390306
nct id: NCT01674127
lead sponsor: 
The present study examined the effects of Methyldopa on uterine artery diameter, uterine
      artery blood flow, umbilical artery and fetal middle-cerebral artery in patients with
      Preeclampsia, using Doppler ultrasound.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Doppler indices
time frame: 7 days
description: In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days.Before and after drug use, Doppler ultrasound test was done by a radiology specialist not informed of patients grouping. Also, pulsatility index, resistance index, systolic/diastolic blood flow ratios of uterine artery, umbilical artery and middle-cerebral artery were evaluated. Registered for all patients, age, BMI, gestational week and the number of pregnancies were among other examined variables.
Doppler indices of examined arteries in studied groups were evaluated by color Doppler ultrasound of model "Hitachi 3/6 MHz".
arm group label: Methyldopa
arm group type: Experimental
description: In case group, 25 patients, under treatment, using Methyldopa for 7 days, received 500 mgs of Methyldopa in its oral form per day and in control group, participants received placebo for 7 days.
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Methyldopa
arm group label: Methyldopa
intervention type: Drug
intervention name: Placebo
arm group label: placebo
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Mojtaba Akbari
mesh term: Pre-Eclampsia
mesh term: Methyldopa