<?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>IRCT20121224011862N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-25</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of mechanical and non-mechanical methods of cervix ripening in women with preterm rupture of membrane  (PROM)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of mechanical and non-mechanical methods of cervix ripening in women with preterm rupture of membrane (PROM)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>104</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51014</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be done one by one (1: 1) using a table of random numbers.104 matte and sealed envelope samples will be prepared.
Randomization will be performed by a non-research person and The type of intervention will be written by random allocation on paper and placed inside the envelopes.Envelopes will be numbered from number 1 to the end.The first person will be given the first envelope and this will continue until the last desired number; There will be 52 people in group 1 and 52 people in group 2, for a total of 104 people.</study_design>
      <phase>2</phase>
      <hc_freetext>Premature rupture of membranes.</hc_freetext>
      <i_freetext>Intervention 1: The group under catheter intervention will use a Foley catheter size 16 with a 30 cc balloon.It will be inserted into the lower segment of the uterus using a sterile And will be filled with 30 cc of distilled water or normal saline,the location of the catheter will be checked every 1 hour by pulling the catheter.If the Foley catheter does not come out automatically, we will remove the catheter within 8 hours after the catheter is placed. Intervention 2: In the group under the intervention with misoprostol, misoprostol tablets with a dose of 25 micrograms will be used sublingually, If the cervix is ​​not ripped, the prescribed dose will be repeated 6 hours later.Oxytocin will be used to induce or enhance uterine contractions after cervical rape and bishop scores greater than or equal to 6. In the absence of effective labor contractions.</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 After the completion of the project, the decision will be made.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Sahaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138665793</zip>
        <telephone>+98 35519161</telephone>
        <email>lahroudin@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Sahaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138665793</zip>
        <telephone>+98 35519161</telephone>
        <email>lahroudin@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age over 34 weeks with  preterm rupture of membrane (PROM)
Singleton pregnancy
Absence of active labour
Cephalic presentation
Unfavorable cervix ( bishop score of 6 or less)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Gestational age under 34 weeks
Lack of proof of preterm rupture of membrane (PROM)
bleeding
Contraindications to natural childbirth
Finding meconium in amniotic fluid at the beginning of the intervention
Suspected of chorioamnionitis
intrauterine growth restriction (IUGR)
Having a history of cesarean section
Breech presentation
Multiple pregnancies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O42.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, unspecified weeks of gestation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The group under catheter intervention will use a Foley catheter size 16 with a 30 cc balloon.It will be inserted into the lower segment of the uterus using a sterile And will be filled with 30 cc of distilled water or normal saline,the location of the catheter will be checked every 1 hour by pulling the catheter.If the Foley catheter does not come out automatically, we will remove the catheter within 8 hours after the catheter is placed.</i_keyword>
      <i_keyword>In the group under the intervention with misoprostol, misoprostol tablets with a dose of 25 micrograms will be used sublingually, If the cervix is ​​not ripped, the prescribed dose will be repeated 6 hours later.Oxytocin will be used to induce or enhance uterine contractions after cervical rape and bishop scores greater than or equal to 6. In the absence of effective labor contractions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interval between induction commencement and obtaining bishop score of 6. Timepoint: During intervention. Method of measurement: In hour unit obtained by manual vaginal exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Delivery before 24 hours. Timepoint: up to 24 hours after intervention. Method of measurement: in hour unit obtained by questionnaire.</sec_outcome>
      <sec_outcome>Neonatal complications. Timepoint: up to 24 hours after birth. Method of measurement: questionnaire and apgar score.</sec_outcome>
      <sec_outcome>Oxytocin requirement. Timepoint: during intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Maternal complications. Timepoint: 24 hours after delivery. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Cesarean delivery incidence. Timepoint: up to 48 hours after intervention. Method of measurement: percentage unit obtained by questionnaire.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-20</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Central Building No.2,Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
