<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/NCT03233880</url>
  </required_header>
  <id_info>
    <org_study_id>Anti Chlamydial treatment</org_study_id>
    <nct_id>NCT03233880</nct_id>
  </id_info>
  <brief_title>Impact of Antichlamydial Treatment on the Rate of Preeclampsia</brief_title>
  <official_title>Impact of Antichlamydial Treatment on the Rate of Preeclampsia Among Egyptian Primigravidae: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, double blinded controlled trial included 1200 healthy primigravidae who&#xD;
      attended an outpatient clinic at 16-20weeks of pregnancy. All women were randomly divided&#xD;
      equally into two groups, group A(600 women) who received antichlamydial treatment in the form&#xD;
      of azithromycin 1 gram single oral dose before 20 weeks of pregnancy and group B (600 women)&#xD;
      who received no treatment(placebo). All participants were followed up for up to 6 weeks&#xD;
      postpartum and observed for the development of preeclampsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preeclampsia complicates approximately 5-8% of all pregnancies and is a major cause of&#xD;
      maternal morbidity and mortality worldwide.Its progress differs among patients; most cases&#xD;
      are diagnosed pre-term. Preeclampsia may also occur up to six weeks post-partum. The present&#xD;
      study included 1200 primigravidae who attended the outpatient clinic of Ain Shams University&#xD;
      maternity Hospital in Cairo, Egypt, for routine antenatal care between July 2016 and&#xD;
      September 2017. The study was approved by the Ethics Committee of Ain Shams University&#xD;
      Maternity Hospital in accordance with local research governance requirements. All&#xD;
      participating women signed an informed consent form inclusion criteria were a primigravida,&#xD;
      singleton pregnancy, maternal age 18-35 years, and pregnancy duration 16-20 weeks at the time&#xD;
      of study inclusion. Exclusion criteria were Women with multi-fetal pregnancy, diabetes&#xD;
      mellitus, chronic hypertension, or chronic renal disease.Computer based Randomization codes&#xD;
      were placed in sequentially numbered, opaque, sealed envelopes by an observer, to be opened&#xD;
      at time of enrollment by a pharmacist in Ain Shams University Hospital who prepared the study&#xD;
      drug and had no further involvement with the patient's care. All data were analyzed before it&#xD;
      was determined which group was received azithromycin and which was received placebo.&#xD;
&#xD;
        -  Azithromycin 1Gm orally, single dose (Xithrone 500 mg two tablets, Amoun, Inc, Cairo,&#xD;
           Egypt) Group (A) OR&#xD;
&#xD;
        -  Matching placebo orally, single dose Group (B). Preeclampsia was defined in the terms of&#xD;
           hypertension and proteinuria. The International Society for the Study of Hypertension&#xD;
           (ISSH) defined preeclampsia as new hypertension and new proteinuria developing after 20&#xD;
           weeks of gestation and regressing remotely after delivery. Hypertension is defined as&#xD;
           diastolic arterial blood pressure ≥90 mmHg on two or more consecutive occasions, at&#xD;
           least 4 hours apart. Proteinuria is defined as ≥ +1 on dipstick test on 2 midstream&#xD;
           urine collections more than 4 hours apart or 24-hour urinary protein ≥ 300mg. Severe&#xD;
           preeclampsia was defined as follows: blood pressure &gt;160/110 mmHg on two occasions at&#xD;
           least 6 hours apart, proteinuria &gt;5 gm/24 hours, oliguria &lt; 500 ml/24 hours,&#xD;
           thrombocytopenia &lt; 100.000/ml, cerebral visual disturbances, epigastric pain, nausea and&#xD;
           vomiting, impaired liver function of unclear etiology or the occurrence of complications&#xD;
           as pulmonary edema, accidental hemorrhage or fetal compromise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</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>
    <intervention_model_description>randomized, double blinded controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pre eclampsia</measure>
    <time_frame>after 20 weeks</time_frame>
    <description>develpment of pre eclampsia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>preterm labour</measure>
    <time_frame>less than completed 37 weeks</time_frame>
    <description>early delivery before term</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>Azithromycin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Azithromycin 1Gm orally, single dose (Xithrone 500 mg two tablets, Amoun, Inc, Cairo, Egypt) will be given to pregnant women at 16/20 weeks of pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>- Matching placebo orally, single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin 1gm</intervention_name>
    <description>Azithromicin 1 gm oral single dose</description>
    <arm_group_label>Azithromycin group</arm_group_label>
    <other_name>anti chlamydial treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PLACEBO</intervention_name>
    <description>placebo</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primigravida, singleton pregnancy, maternal age 18-35 years, and pregnancy duration&#xD;
             16-20 weeks at the time of study inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with multi-fetal pregnancy, diabetes mellitus, chronic hypertension, or chronic&#xD;
             renal disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adel S Salah El-Din, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Proffesor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adel S Salah El-Din, MD</last_name>
    <phone>01005223586</phone>
    <email>shafikadel@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>adel S salah el-din, MD</last_name>
      <phone>01005223586</phone>
      <email>shafikadel@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>ADEL SHAFIK SALAH EL-DIN</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>chlamydia</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</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/NCT03233880
org study id: Anti Chlamydial treatment
nct id: NCT03233880
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized, double blinded controlled trial included 1200 healthy primigravidae who
      attended an outpatient clinic at 16-20weeks of pregnancy. All women were randomly divided
      equally into two groups, group A(600 women) who received antichlamydial treatment in the form
      of azithromycin 1 gram single oral dose before 20 weeks of pregnancy and group B (600 women)
      who received no treatment(placebo). All participants were followed up for up to 6 weeks
      postpartum and observed for the development of preeclampsia.
Preeclampsia complicates approximately 5-8% of all pregnancies and is a major cause of
      maternal morbidity and mortality worldwide.Its progress differs among patients; most cases
      are diagnosed pre-term. Preeclampsia may also occur up to six weeks post-partum. The present
      study included 1200 primigravidae who attended the outpatient clinic of Ain Shams University
      maternity Hospital in Cairo, Egypt, for routine antenatal care between July 2016 and
      September 2017. The study was approved by the Ethics Committee of Ain Shams University
      Maternity Hospital in accordance with local research governance requirements. All
      participating women signed an informed consent form inclusion criteria were a primigravida,
      singleton pregnancy, maternal age 18-35 years, and pregnancy duration 16-20 weeks at the time
      of study inclusion. Exclusion criteria were Women with multi-fetal pregnancy, diabetes
      mellitus, chronic hypertension, or chronic renal disease.Computer based Randomization codes
      were placed in sequentially numbered, opaque, sealed envelopes by an observer, to be opened
      at time of enrollment by a pharmacist in Ain Shams University Hospital who prepared the study
      drug and had no further involvement with the patient's care. All data were analyzed before it
      was determined which group was received azithromycin and which was received placebo.

        -  Azithromycin 1Gm orally, single dose (Xithrone 500 mg two tablets, Amoun, Inc, Cairo,
           Egypt) Group (A) OR

        -  Matching placebo orally, single dose Group (B). Preeclampsia was defined in the terms of
           hypertension and proteinuria. The International Society for the Study of Hypertension
           (ISSH) defined preeclampsia as new hypertension and new proteinuria developing after 20
           weeks of gestation and regressing remotely after delivery. Hypertension is defined as
           diastolic arterial blood pressure ≥90 mmHg on two or more consecutive occasions, at
           least 4 hours apart. Proteinuria is defined as ≥ +1 on dipstick test on 2 midstream
           urine collections more than 4 hours apart or 24-hour urinary protein ≥ 300mg. Severe
           preeclampsia was defined as follows: blood pressure >160/110 mmHg on two occasions at
           least 6 hours apart, proteinuria >5 gm/24 hours, oliguria < 500 ml/24 hours,
           thrombocytopenia < 100.000/ml, cerebral visual disturbances, epigastric pain, nausea and
           vomiting, impaired liver function of unclear etiology or the occurrence of complications
           as pulmonary edema, accidental hemorrhage or fetal compromise.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, double blinded controlled trial
primary purpose: Prevention
masking: Double (Participant, Care Provider)
masking description: double blind
measure: Pre eclampsia
time frame: after 20 weeks
description: develpment of pre eclampsia
measure: preterm labour
time frame: less than completed 37 weeks
description: early delivery before term
arm group label: Azithromycin group
arm group type: Active Comparator
description: Azithromycin 1Gm orally, single dose (Xithrone 500 mg two tablets, Amoun, Inc, Cairo, Egypt) will be given to pregnant women at 16/20 weeks of pregnancy
arm group label: placebo group
arm group type: Placebo Comparator
description: - Matching placebo orally, single dose
intervention type: Drug
intervention name: Azithromycin 1gm
description: Azithromicin 1 gm oral single dose
arm group label: Azithromycin group
other name: anti chlamydial treatment
intervention type: Other
intervention name: PLACEBO
description: placebo
arm group label: placebo group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adel S Salah El-Din, MD
role: Principal Investigator
affiliation: Assistant Proffesor
last name: Adel S Salah El-Din, MD
phone: 01005223586
email: shafikadel@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: ADEL SHAFIK SALAH EL-DIN
investigator title: Assistant professor
mesh term: Pre-Eclampsia
mesh term: Eclampsia
mesh term: Azithromycin
sharing ipd: Undecided