<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170513033941N71</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-21</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effects of N-acetylcysteine administration in treatment of women with gestational diabetes mellitus</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with gestational diabetes mellitus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45746</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 76 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Gestational diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally. Intervention 2: Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Susan Assadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5546 3378</telephone>
        <email>susanassadpour67@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zohreh Tabassi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5546 3378</telephone>
        <email>tabassiz@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with gestational diabetes mellitus.
Individuals aged 18 to 40 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Overt diabetes mellitus
Taking any antioxidant agents 3 months before the intervention
Needing insulin therapy
Hypo and hyperthyroidism
Unwillingness to cooperate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.</i_keyword>
      <i_keyword>Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Calculation using HOMA formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>HDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.</sec_outcome>
      <sec_outcome>Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.</sec_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Cesarean section rate. Timepoint: Delivery time. Method of measurement: checklist.</sec_outcome>
      <sec_outcome>Preterm delivery. Timepoint: Delivery time. Method of measurement: checklist.</sec_outcome>
      <sec_outcome>Polyhydramnios. Timepoint: End-of-trial. Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Pre-eclampsia rate. Timepoint: During intervention. Method of measurement: checklist.</sec_outcome>
      <sec_outcome>Macrosomia rate. Timepoint: Delivery time. Method of measurement: checklist.</sec_outcome>
      <sec_outcome>Low birth weight. Timepoint: Delivery time. Method of measurement: checklist.</sec_outcome>
      <sec_outcome>Newborns’ hyperbilirubinemia. Timepoint: Delivery time. Method of measurement: checklist.</sec_outcome>
      <sec_outcome>Newborns’ hospitalization. Timepoint: Delivery time. Method of measurement: checklist.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-03</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
