<?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>IRCT20090701002114N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-07</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of magnesium sulfate on cervical progression</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the local effect of magnesium sulfate on cervical progression during labor in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50625</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: using the randomized block method, in the form of quadruple blocks in two double-blind intervention groups And control will be assigned. In this way, a part of the table of random numbers is selected and AB code is used for 0 to 4 numbers and BA code is used for 5 to 9 numbers. In this study, code A represents the group receiving magnesium sulfate and code B represents the placebo group, Blinding description: Due to the fact that in the intervention group, 10 cc of magnesium sulfate 50% will be used topically through the vagina using a syringe, in the control group, under the same conditions, only distilled water instead of magnesium sulfate drug for blinding The researcher and the patient will be used. It should be noted that vials that are completely similar to distilled water and magnesium sulfate drug without a drug name label will be used. These vials will be separated by a label containing a code (by a specific pharmaceutical company) that the researcher is completely unaware of their nature.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor progress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:. In the intervention group, after the onset of the active phase, which is dilated 3-5 cm with active uterine contractions and having a urine score of 5, the researcher pours 10 cc of 50% magnesium sulfate into the cervix from the fingertips with a 10 cc syringe by the examiner. Be. If a ruptured bladder is seen, 10 cc of magnesium sulfate is poured on the cervix again. Intervention 2: Control group:, distilled water is used instead of magnesium sulfate for blinding.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr.fateme yari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalvand - 4 km of Khorramabad-Borujerd road, medical school</address>
        <city>khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>009833120133</telephone>
        <email>yari.f@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.fateme yari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalvand, km 4, Khorramabad-Borujerd road, medical school</address>
        <city>khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>009833120133</telephone>
        <email>yari.f@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous women
18-35 years old
Fetal age 37-42 full weeks
live single fetus
Estimated weight 2500-4000 gr
Spontaneous onset of the labor process
low risk pregnancy
body mass index 19/8-30</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Uncertain pattern of fetal heart rate
Occurrence of placental abruption and umbilical cord prolapse's lack of patient cooperation and mismatch of fetal head with mother pelvis
umbilical cord prolapse's
lack of patient cooperation
cephalopelvic disappropriation Based on the diagnosis of the treating physician</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>Intervention group:. In the intervention group, after the onset of the active phase, which is dilated 3-5 cm with active uterine contractions and having a urine score of 5, the researcher pours 10 cc of 50% magnesium sulfate into the cervix from the fingertips with a 10 cc syringe by the examiner. Be. If a ruptured bladder is seen, 10 cc of magnesium sulfate is poured on the cervix again.</i_keyword>
      <i_keyword>Control group:, distilled water is used instead of magnesium sulfate for blinding</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of magnesium sulfate on cervical effacement. Timepoint: Every two hours until the cervix is fully open. Method of measurement: Through internal examination of the vagina, which is expressed as a percentage.</prim_outcome>
      <prim_outcome>The effect of magnesium sulfate on cervical dilatation. Timepoint: Every two hours until the cervix is fully open. Method of measurement: Through an internal vaginal examination expressed in centimeters.</prim_outcome>
      <prim_outcome>Effect of magnesium sulfate on cervical position. Timepoint: Every two hours until the cervix is fully. Method of measurement: Through an internal vaginal examination expressed in centimeters.</prim_outcome>
      <prim_outcome>Effect of magnesium sulfate on cervical consistency. Timepoint: Every two hours until the cervix is fully. Method of measurement: Soft to medium hard.</prim_outcome>
      <prim_outcome>Effect of magnesium sulfate on cervical position. Timepoint: Every two hours until the cervix is fully. Method of measurement: Anterior posterior medial.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Effect of magnesium sulfate on Bishab score. Timepoint: Every two hours. Method of measurement: In terms of score.</sec_outcome>
      <sec_outcome>Effect of magnesium sulfate on the duration of labor. Timepoint: Every two hours. Method of measurement: per second.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-05</approval_date>
        <contact_name>Ethics committe of Lorestan University of Medical Sciences</contact_name>
        <contact_address>university campus complex, km 3 of Khorramabad-Borujerd road, Khorramabad, Lorestan Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
