<?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>IRCT20170515033984N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-04</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of pregnancy outcomes among mothers with gestational diabetes using mobile application-assisted remote patient monitoring</public_title>
      <acronym></acronym>
      <scientific_title>Comparative investigation of pregnancy outcomes among mothers with gestational diabetes using mobile application-assisted remote patient monitoring for blood glucose and mothers receiving conventional care</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57724</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be applied using the simple method. Indeed, 75 participants will be divided into two sets of 25 and 50 people. After that, in excel, 25 'A's and 50 'B's will be written under each other. In the adjacent column, 75 random numbers will be generated using the RAND function. Finally, by sorting both columns by randomly generated numbers, the application of A (Intervention) and B (Control) for each patient will be determined based on her turn of referral.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational Diabetes Mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: blood sugar measuring device will be provided to this group members and the pertinent mobile application will be installed for them. Mothers under the attendance of the specialist will have to measure their blood sugar on a daily basis and record them. Moreover, the application will do the initial analysis of the data and will warn the patient, her doctor, and her trusted person when needed. Intervention 2: Control group:  they will receive conventional GDM care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Patients privacy</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Abbasi-Kangevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>502, 5th floor, No.6, Nabavi dead end, Shariati St, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 2243 9770</telephone>
        <email>mohsen.abbasi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saghar Salehpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velenjak St. , Shahid Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>saghar.salehpour2014@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnancy
Age between 18 to 40 years old
Singleton pregnancy
Diagnosis of gestational diabetes mellitus (GDM) by pregnancy screening tests
Referral to the Taleghani Hosbital, Tehran, to receive pregnancy care
Possessing smart phone or tablet at home
Being able to use smart phone applications</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of any other underlying disease including cardiopulmonary disease
Presence of pregnancy complications including placenta previa or pre-eclampsia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O24.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: blood sugar measuring device will be provided to this group members and the pertinent mobile application will be installed for them. Mothers under the attendance of the specialist will have to measure their blood sugar on a daily basis and record them. Moreover, the application will do the initial analysis of the data and will warn the patient, her doctor, and her trusted person when needed.</i_keyword>
      <i_keyword>Control group:  they will receive conventional GDM care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occurrence of hypoglycemia in mother. Timepoint: In case of insulin administration four times per day, otherwise, once per day. Method of measurement: Patient files or data extracted from the application database.</prim_outcome>
      <prim_outcome>Occurrence of hypoglycemia in neonate. Timepoint: Once daily. Method of measurement: Patient files or data extracted from the application database.</prim_outcome>
      <prim_outcome>Number of measured out of control blood sugar. Timepoint: In case of insulin administration four times per day, otherwise, once per day. Method of measurement: In case of insulin administration four times per day, otherwise, once per day.</prim_outcome>
      <prim_outcome>Insulin administration requirement. Timepoint: per visit with the physician. Method of measurement: Patient files.</prim_outcome>
      <prim_outcome>Number of hospitalizations for controlling blood sugar. Timepoint: Per incidence during the study. Method of measurement: پرونده بیمار.</prim_outcome>
      <prim_outcome>First minute Apgar score under seven. Timepoint: During delivery. Method of measurement: Patient files.</prim_outcome>
      <prim_outcome>Fifth minute Apgar score under seven. Timepoint: During delivery. Method of measurement: Patient files.</prim_outcome>
      <prim_outcome>Preterm birth. Timepoint: After birth. Method of measurement: Patient files.</prim_outcome>
      <prim_outcome>Macrosomia in new born. Timepoint: After birth. Method of measurement: Patient files.</prim_outcome>
      <prim_outcome>Small/large for gestational age. Timepoint: After birth. Method of measurement: Patient files.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother satisfaction with the application. Timepoint: After termination of pregnancy. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Physician and medical staff satisfaction with the application. Timepoint: After the termination of study. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Patient anxiety. Timepoint: After the termination of study. Method of measurement: PAID-5 Questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-31</approval_date>
        <contact_name>Ethics Committee School of Medicine Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Taleghani Hospital, Shahid E'rabi St, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
