<?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>IRCT2016050527643N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-23</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>cervical ripening and termination of term pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of vaginal Misoprostol, Laminaria and Isosorbide Dinitrate on cervical ripening before labor induction among the term parturients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22604</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>vaginal delivery.</hc_freetext>
      <i_freetext>Intervention 1: in the first group, Misoprostol, 25 microgram of this drug as oral Tablet will insert in posterior fornix of vagina.The dose can be repeated up to 2 times every 6 hours. The second doses, if  Bishop score is less than 8 per examination  will be repeated every 6 hours. Administration of low dose Oxytocin immediately  after preparation of the cervix (active phase of labor with utrine contracture less than 3 in 10 minutes ) or no response to procedures will be performed after 12 hours. Intervention 2: in the second group, Isosorbide Dinitrate, 40 milligram of this drug as Oral Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third doses, if Bishop is less than 8 will be repeated every 4 hours. Administration of low dose Oxytocin immediately after preparation of the cervix (active phase of labor with utrine contracture less than 3 in 10 minutes ) or no response to procedures will be performed after 12 hours. Intervention 3: In third group, first, maternal vagina will be cleaned with Bethadine. After the Speculum inserted, the anterior lip of the Cervix will be taken with Tenaculum and Laminaria will be taken down depending on the size of the cervix so that its tip has been diced near the internal opening of the cervix.Then after 12 hours Laminara will be taken out. Administration of low dose Oxytocin immediately after preparation of the cervix (active phase of labor with utrine contracture less than 3 in 10 minutes ) or no response to procedures will be performed after 12 hours.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Haeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3864 3035</telephone>
        <email>haeri.sima@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnaz Sovizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Sabzevar University of Medical Sciences</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 4444 6070</telephone>
        <email>soiizib1@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:term pregnancy ; bishop score less than 6 ; cephalic presentation ; singleton pregnancy &#13;
Exclusion criteria:use of another way for cervical ripenig ; contraindication of labor inducton or NVD ; mother's comorbidity ; rupture of fetus membrane ; severe preeclampsia ; vaginal bleeding ; Placenta previa ; having a spontaneous contraction</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spontaneous vertex delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>in the first group, Misoprostol, 25 microgram of this drug as oral Tablet will insert in posterior fornix of vagina.The dose can be repeated up to 2 times every 6 hours. The second doses, if  Bishop score is less than 8 per examination  will be repeated every 6 hours. Administration of low dose Oxytocin immediately  after preparation of the cervix (active phase of labor with utrine contracture less than 3 in 10 minutes ) or no response to procedures will be performed after 12 hours.</i_keyword>
      <i_keyword>in the second group, Isosorbide Dinitrate, 40 milligram of this drug as Oral Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third doses, if Bishop is less than 8 will be repeated every 4 hours. Administration of low dose Oxytocin immediately after preparation of the cervix (active phase of labor with utrine contracture less than 3 in 10 minutes ) or no response to procedures will be performed after 12 hours.</i_keyword>
      <i_keyword>In third group, first, maternal vagina will be cleaned with Bethadine. After the Speculum inserted, the anterior lip of the Cervix will be taken with Tenaculum and Laminaria will be taken down depending on the size of the cervix so that its tip has been diced near the internal opening of the cervix.Then after 12 hours Laminara will be taken out. Administration of low dose Oxytocin immediately after preparation of the cervix (active phase of labor with utrine contracture less than 3 in 10 minutes ) or no response to procedures will be performed after 12 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cervical ripening. Timepoint: On admissiom and 12 hours later and before insertion of each dose. Method of measurement: Vaginal exam based on Bishop score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal complications (Over stimulation of the uterus, headaches, tachycardia, hypotension, nausea, vomiting, and dizziness). Timepoint: During at the intervention. Method of measurement: Observation and Examination.</sec_outcome>
      <sec_outcome>Method of delivery. Timepoint: During at the intervention. Method of measurement: Observation and Examination.</sec_outcome>
      <sec_outcome>Duration of the first stage of labor. Timepoint: Active stage of labor. Method of measurement: Hour.</sec_outcome>
      <sec_outcome>Neonatal outcomes (Apgar score at first and fifth minutes, birth weight, hospitalization of neonate in the Neonatal Intensive Care Unit). Timepoint: During at the intervention. Method of measurement: Observation and Examination.</sec_outcome>
      <sec_outcome>Necessity of induction. Timepoint: During at the intervention. 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>Vice Chancellor for Research of Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Sabzevar University of Medical Sciences, Asadabadi St Sabzevar  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
