<?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>IRCT20201003048910N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-18</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of oral and vaginal  isosorbide mononitrate  tablets and oral propranolol tablets on cervical preparation.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of oral and vaginal  isosorbide mononitrate and oral propranolol tablets on cervical preparation before induction in primiparous  and term pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51380</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: The primiparous  term pregnancy who needed induction of labor due to termination of pregnancy and adverse cervix were easily selected and based on a random number table into four groups of recipients of forty mg isosorbide vaginal mononitrate (n = 30) and oral isosorbide mononitrate. Forty mg (30) patients and 40 mg oral propranolol tablets (two 20 mg tablets every twelve hours to the dose (n = 30) and the control group (n = 30) were divided, Blinding description: The person assessing the consequences is kept blind.</study_design>
      <phase>3</phase>
      <hc_freetext>cervical ripening.</hc_freetext>
      <i_freetext>Intervention 1: In the first group,  single dose of 40 mg of isosorbide mononitrate from Aria drug will be placed vaginally in the posterior fornix by the researcher. Intervention 2: In the second group  single dose of 40 mg Isosorbide mononitrate tablets are given orally from Aria Pharmaceutical Company. Intervention 3: Oral propranolol tablets are given orally at single dose of 20 mg from Dr. Obidi Pharmaceutical Company. Intervention 4: Control group: The control group is given 24 hours to soften the cervix and no medication is prescribed.</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>Mahnaz Tajpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karim Khan, North Villa</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1939963559</zip>
        <telephone>009822785738</telephone>
        <email>mahnaz_tajpour@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mahnaz tajpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karim Khan, North Villa</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1939963559</zip>
        <telephone>+98 21 2278 5738</telephone>
        <email>mahnaz_tajpour@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Includes 37-40 weeks gestation
live fetus
Noli Par
single fetus
cephalic
intact membranes
under two  bishop scores
fetal weight less than 4 kg
normal fetal health monitoring result
no uterine contractions
There were no systemic problems in the history and clinical examination.</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Abnormality of fetal appearance with pelvis or non-cephalic
presence of uterine scar
previous history of cesarean section
history of cervical cone (conization)
polyhydramnios
history of drug allergy
contraindications to vaginal delivery
aginal bleeding during third trimester
placenta previa
multiple pregnancy
suspected fetal abnormality
bishop score above 3
uterine contractions
uncertain NST
chorioamnionitis
history of asthma
active genital herpes
any contraindications to induction of labor
systolic pressure less than 90
Cardiovascular disease
severe preeclampsia
alcoholism
history of headache</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group,  single dose of 40 mg of isosorbide mononitrate from Aria drug will be placed vaginally in the posterior fornix by the researcher.</i_keyword>
      <i_keyword>In the second group  single dose of 40 mg Isosorbide mononitrate tablets are given orally from Aria Pharmaceutical Company.</i_keyword>
      <i_keyword>Oral propranolol tablets are given orally at single dose of 20 mg from Dr. Obidi Pharmaceutical Company.</i_keyword>
      <i_keyword>Control group: The control group is given 24 hours to soften the cervix and no medication is prescribed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical ripening. Timepoint: 24 hours after the start of the study. Method of measurement: vaginal examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of the first phase of labor (including latent and active phase). Timepoint: During the study. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Duration of the second stage of labor (from complete dilatation to fetal delivery ). Timepoint: During the study. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Duration of the third stage of labor (from the time of embryo departure to complete placental abruption). Timepoint: During the study. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Method of childbirth. Timepoint: During the study. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Maternal complications (headache, nausea, vomiting and dizziness). Timepoint: During the study. Method of measurement: Observation and examination.</sec_outcome>
      <sec_outcome>Neonatal outcomes (first and fifth minute Apgar score, umbilical cord PH, neonatal hospitalization in intensive care unit). Timepoint: During the study. Method of measurement: Observation and examination.</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>drug</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics Committee in Research, School of Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>No18,deldar,baradaran rahmani avenu,sadr blv Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
