<?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>IRCT20141001019351N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of exercise on preventing gestational diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supervised exercise in the prevention of gestational diabetes mellitus in nulliparous women: A randomized control clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39150</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This is a parallel randomized clinical trial, Randomization description: Randomization will be done after initial registration and obtaining informed consent. Random allocation will be done based on a list obtained from www.Randomization.com. After entering the required information, this website provides two lists of 40 people in two groups of intervention and comparison. At the end of each week, the project secretary will place subjects in the order of entry into the study in the intervention and comparison lists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational diabetes melitus (GDM).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group program will be based on the principles of the design of the workout, by specifying the duration, severity, repetition, and type of exercise. The duration of the training in the first week is 60 minutes, in the second week, 100, and the third week, 150, and from the fourth week thereafter, 160 minutes. will be . Exercise intensity throughout the week with moderate intensity and based on the severity of talk test. Repeat the exercise in the first week, 4 times a week, the first two days, 10 minutes and 2 days later, 20 minutes, and from the second week, 5 days a week. Which will be divided according to the timing between days. Types of exercise in the first week, three times a week, once a practice of aerobics and Pilates, and from the second week to two days of walking and three days of aerobic and Pilates exercises during pregnancy. Aerobic exercises include a warming and cooling program and cardio exercises, and Pilates exercises are called seated xeecise exercises. Intervention 2: Control group: Control group can take physical activity while receiving usual care during pregnancy.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient

When:
IPD: 2019Ethic form: 2019

To whom:
IPD: Researcher &amp; Patient Ethic form: Patient

Conditions:
IPD: Ethic form: Awareness of test results

Where to obtain:
IPD:counseling and delivery service of the Avayetavalod

How to obtain:
IPD:Application form for the researcher and, if agreed, coordinated with the secretary of the design and attendance at the counseling and delivery service of the Avayetavalod

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>tayebeh zarezadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damghan velayat Hospital</address>
        <city>Damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671637881</zip>
        <telephone>+98 23 3522 5124</telephone>
        <email>velayathos@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>tayebeh zarezadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damghan velayat Hospital</address>
        <city>damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671637881</zip>
        <telephone>+98 23 3522 5124</telephone>
        <email>velayathos@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>.Healthy pregnancy  
Normal  Fasting plasma glucose in the first weeks of pregnancy
Gestational age 18 to 20 weeks to start the plan
Mother age 18 to 35 years old 
A resident of Damghan   
Control and care of pregnancy in the city of Damghan 
Contraindications without exercisein Pregnancy 
Adherence to the implementation of the plan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>One of the obstacles to not doing exercise in pregnancy
Mother's request to leave the plan at any time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00-O08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pregnancy with abortive outcome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group program will be based on the principles of the design of the workout, by specifying the duration, severity, repetition, and type of exercise. The duration of the training in the first week is 60 minutes, in the second week, 100, and the third week, 150, and from the fourth week thereafter, 160 minutes. will be . Exercise intensity throughout the week with moderate intensity and based on the severity of talk test. Repeat the exercise in the first week, 4 times a week, the first two days, 10 minutes and 2 days later, 20 minutes, and from the second week, 5 days a week. Which will be divided according to the timing between days. Types of exercise in the first week, three times a week, once a practice of aerobics and Pilates, and from the second week to two days of walking and three days of aerobic and Pilates exercises during pregnancy. Aerobic exercises include a warming and cooling program and cardio exercises, and Pilates exercises are called seated xeecise exercises.</i_keyword>
      <i_keyword>Control group: Control group can take physical activity while receiving usual care during pregnancy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FPG fasting plasma glucose. Timepoint: Week 7 to 10 and 24 to 28 weeks pregnant. Method of measurement: Fasting Blood Sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>OGTT(50Glocose). Timepoint: 24- 28 gestational age. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Pregnant mother weighing. Timepoint: The first trimester of gestation, the second trimester of pregnancy, the third trimester of pregnancy, the termination of pregnancy. Method of measurement: Weighing scale for adults.</sec_outcome>
      <sec_outcome>Type of delivery. Timepoint: At birth. Method of measurement: The case is admitted to the pregnant mother's hospital.</sec_outcome>
      <sec_outcome>Baby weight. Timepoint: The first hour of birth. Method of measurement: Baby weighing scale.</sec_outcome>
      <sec_outcome>Baby's height. Timepoint: The first hour of birth. Method of measurement: Measuring meter.</sec_outcome>
      <sec_outcome>Round the head of the baby. Timepoint: The first hour of birth. Method of measurement: Measuring meter.</sec_outcome>
      <sec_outcome>Baby's chest. Timepoint: The first hour of birth. Method of measurement: Measuring meter.</sec_outcome>
      <sec_outcome>Apgar's first minute baby. Timepoint: The first minute of the baby's birth. Method of measurement: Apgar score for baby.</sec_outcome>
      <sec_outcome>Apgar's fifth minute baby. Timepoint: The  fifth minute of the baby's birth. Method of measurement: Apgar score for baby.</sec_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: From hospital admission to discharge. Method of measurement: The case is admitted to the pregnant mother's hospital.</sec_outcome>
      <sec_outcome>Gestational age at the end of pregnancy. Timepoint: At birth. Method of measurement: Gestational age based on ultrasound 8 to 10 weeks based on CRL.</sec_outcome>
      <sec_outcome>Percent oxygen saturation. Timepoint: Minutes 1- 2 -3 -4 -5 -10. Method of measurement: Baby Oximeter pulse device.</sec_outcome>
      <sec_outcome>Duration of active phase of labor. Timepoint: When admitted to the hospital for termination of pregnancy. Method of measurement: Hospital file - Partograph form.</sec_outcome>
      <sec_outcome>Determining the rate of admission to the hospital after delivery. Timepoint: The first 24 hours of birth. Method of measurement: Newborn hospital records.</sec_outcome>
      <sec_outcome>The need for resuscitation measures in the baby. Timepoint: Baby birth. Method of measurement: Newborn hospital records.</sec_outcome>
      <sec_outcome>Childbirth injuries. Timepoint: The first 24 hours after birth. Method of measurement: Newborn hospital records.</sec_outcome>
      <sec_outcome>Maternal Maternal Injuries. Timepoint: The first 2 hours after childbirth. Method of measurement: Maternity hospital file.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-06</approval_date>
        <contact_name>islamic azad university, semnan branch</contact_name>
        <contact_address>islamic azad university, damghan branch damghan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
