<?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>IRCT20170121032085N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-03</date_registration>
      <primary_sponsor>Vice chancellor for research, shahid beheshty  University of Medical Sciences</primary_sponsor>
      <public_title>The effect of local  magnesium sulfate on the progression of effacement, dilatation, process and delivery outcomes</public_title>
      <acronym></acronym>
      <scientific_title>The effect of local magnesium sulfate on the progression of effacement, dilatation, process and delivery outcomes in nulipar women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25084</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Other design features: There is no other explanation, Randomization description: Randomization was done using random numbers tabel . For the control and intervention group, codes A and B were used as contractions. Then, before the intervention, using Excel software, a randomized table for the order of sampling was prepared, Blinding description: Before starting the intervention, all the specimens needed explanations, but the samples were not known to be in the intervention or control group. The drug  or placebo was prescribed by the investigator, but the assistant in the study who performed the examinations with him from the  treatment  group was unaware. The attending physician was aware of the patient's treatment group, but the person analyzing the statistical information from the  treatment  group was unaware.</study_design>
      <phase>3</phase>
      <hc_freetext>labor progress.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group in the active phase of labor, 10 cc magnesium sulfate is shed 50% on the uterine cavity. If within 2 hours after examination of the uterine cavity, the other 10 cc magnesium sulfate 50% on the uterine crater Shed. Intervention 2: In the control group, in the active phase of labor, 10 cc of water is excreted in the uterine cavity. If, during the next 2 hours, the condition of the uterine cavity has not changed in the examination, once again 10 cc of mucosal sulfate is poured over t.</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 To keep confidential secrets of contributors</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezoo Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave., opposite Shahid Rajaee Hospital, Faculty of Nursing Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>Arezuheydari71@gmail.com</email>
        <affiliation>Shahid Beheshti university of medcal science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezu Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr Ave., opposite Shahid Rajaee Hospital, Faculty of Nursing Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>Arezuheydari71@gmail.com</email>
        <affiliation>Shahid Beheshti university of Medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All nulipar  pregnant women
Gestational age 37-42 weeks
18-35 years old
Live and single fetus
cefalic presentasion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having chronic, risky illness
CPD disorder
Estimated baby  weight more than 4000 grams or less than 2500 grams
High risk pregnancy
Having history of infertility</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group in the active phase of labor, 10 cc magnesium sulfate is shed 50% on the uterine cavity. If within 2 hours after examination of the uterine cavity, the other 10 cc magnesium sulfate 50% on the uterine crater Shed</i_keyword>
      <i_keyword>In the control group, in the active phase of labor, 10 cc of water is excreted in the uterine cavity. If, during the next 2 hours, the condition of the uterine cavity has not changed in the examination, once again 10 cc of mucosal sulfate is poured over t</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>During the active phase of labor. Timepoint: During the intervention. Method of measurement: Vaginal examination.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: at the birth. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Apgar scores in minutes 1 and 5. Timepoint: 1 and 5 minute after delivery. Method of measurement: observe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postpartum haemorrhage and laceration of the delivery channel. Timepoint: After delivery and intervention. Method of measurement: Blood testing and inspection.</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>Vice chancellor for research, shahid beheshty  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-18</approval_date>
        <contact_name>Shahid Beheshti university of Medical science</contact_name>
        <contact_address>Tehran, Valiasr St., in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
