<?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>IRCT20160524028038N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-27</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Sildenafil and fetal heart rate</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sildenafil on fetal heart rate patterns during labor in primiparous pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent ( A,B) for the allocation of subjects to intervention ( A) and control (B) groups will be used, Blinding description: The blinding method is patients will not be aware of their allocation to study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fetal heart rate during labor.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to induction and routine interventions during labor, they will receive oral sildenafil at a dose of 50 mg every 8 hours up to a maximum of 150 mg, the first dose of which is prescribed at the beginning of the study. Intervention 2: Control group: Induction and routine interventions are performed.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad</address>
        <city>No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916839319</zip>
        <telephone>+98 917 793 1581</telephone>
        <email>zasadik66@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916839319</zip>
        <telephone>+98 917 793 1581</telephone>
        <email>zasadik66@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First and term pregnancy (gestational age over 37 weeks)
Absence of pre-eclampsia, hypertension and gestational diabetes and absence of underlying disease in the mother
Not getting magnesium sulfate
Absence of fetal growth restriction, polyhydramnios and oligohydramnios of the fetus
Absence of prolonged rapture of membrane (more than 12 hours)
singleton pregnancy
Absence of structural abnormalities
Cephalic display
Candidate for vaginal delivery
Cervical dilatation less than 4 cm at the time of admission
candidate for induction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction of the mother</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O76</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormality in fetal heart rate and rhythm complicating labor and delivery</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 addition to induction and routine interventions during labor, they will receive oral sildenafil at a dose of 50 mg every 8 hours up to a maximum of 150 mg, the first dose of which is prescribed at the beginning of the study.</i_keyword>
      <i_keyword>Control group: Induction and routine interventions are performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fetal heart rate patterns. Timepoint: Continuous fetal heart rate monitoring. Method of measurement: In this study, the normal fetal heart rate pattern based on the standard protocol means a heart rate between 110-160 beats per minute and a beat-to-beat variability of 5-25 beats per minute during labor and the pathological fetal heart rate pattern means a late deceleration in heart rate relative to to uterine contractions, early deceleration means a decrease in heart rate at the same time as uterine contractions, variable deceleration means a decrease in heart rate unrelated to uterine contractions, prolong deceleration means a deceleration in heart rate of more than 2 minutes in 10 minutes of continuous heart rate monitoring, tachycardia means a heart rate of more than 160 and bradycardia means a heart rate of less than 110 and reduced variability means changes of less than 5 beats per minute.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-24</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
