<?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>IRCT20120718010324N56</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-22</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the effect of cervical ripening baloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor</public_title>
      <acronym></acronym>
      <scientific_title>Labor induction with unfavorable cervix;  Assessing the effect of cervical ripening balloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47056</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to 3 groups by stratified randomized blocking method (stratification will be based on parity, primiparous in one strata and parity 2 - 4 in another strata) with block sizes of 3 and 6 with a 1: 1: 1 ratio  as follows: 
Group 1: 25 µg  of vaginal misoprostol, Group 2: 4000 mg Vaginal capsule of evening primrose oil (EPO) and Group 3: Cervical Ripening Baloon.
for Allocation Concealment, the type of intervention will be written on piece of paper and placed inside the serial numbered envelopes. After obtaining informed consent, the relevant envelope will be opened and the intervention will be performed, Blinding description: In order to blind the drugs, two envelopes with the same content will be prepared for each participant, which will contain 4 capsules (EPO or Placebo  capsules) and one tablet (Misoprostol or Placebo) and will be packaged in the same way. Envelopes will be coded by another person. About cervical Ripening Baloon, there is no possible for blinding.</study_design>
      <phase>3</phase>
      <hc_freetext>Labor induction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: vaginal capsule evening primrose oil 4000 mg. Intervention 2: Intervention group 2: Double balloon cervical ripening catheter. Intervention 3: Intervention group 3: vaginal tablet misoprostol 25 microgram.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The results of clinical study will be published as article

When:
Immediately after publishing the results

To whom:
All researchers

Conditions:
Scientific using with citation to article

Where to obtain:
mirghafourvandm@tbzmed.ac.ir

How to obtain:
Up to one week after communication by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahla Hemmatzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>shahla_obs@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Mirghafourvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing &amp; Midwifery, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>mirghafourvandm@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age≥ 40 weeks
Vertex presentation
Parity ≤ 4
Single  pregnancy
Lack of vaginal delivery contraindication
Uncomplicated pregnancy
Bishop score less than 4
Favorable non stress test in admission
Lack of effective  uterine contractions (less than three contractions in 30 minutes)
Intact amniotic sac</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Amniotic fluid volume Disorders
Intra Uterine Growth Retardation
Fetal macrosomia
Any contraindication for evening primrose oil use such as history of seizures in the mother or use of anticonvulsant drugs
Contraindication for labor induction
High risk pregnancy
Existence of chronic or systemic disease such as diabetes and hypertension
Existence of scar on the uterus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O83.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified assisted single delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: vaginal capsule evening primrose oil 4000 mg</i_keyword>
      <i_keyword>Intervention group 2: Double balloon cervical ripening catheter</i_keyword>
      <i_keyword>Intervention group 3: vaginal tablet misoprostol 25 microgram</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bishop score. Timepoint: Before intervention and every 4 hours after intervention until 12 hours. Method of measurement: Bishop scoring scale.</prim_outcome>
      <prim_outcome>Duration of first stage of labor. Timepoint: From beginning of induction until childbirth. Method of measurement: Partograph.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of second stage of labor. Timepoint: After full dilatation. Method of measurement: Partograph.</sec_outcome>
      <sec_outcome>Duration of third stage of labor. Timepoint: After neonatal delivery until deliver the placenta. Method of measurement: Partograph.</sec_outcome>
      <sec_outcome>Type of delivery (cesarean section rate). Timepoint: After delivery. Method of measurement: Researcher's designed form.</sec_outcome>
      <sec_outcome>First and fifth minute Apgar score. Timepoint: After delivery. Method of measurement: Baby profile sheet.</sec_outcome>
      <sec_outcome>Use of oxytocin for labor induction. Timepoint: During labor. Method of measurement: Partograph and labor process improvement sheet.</sec_outcome>
      <sec_outcome>Mean score of birth satisfaction. Timepoint: 12- 24 hours after delivery. Method of measurement: Birth Satisfaction Scale- revised (BSS-R).</sec_outcome>
      <sec_outcome>Side effects. Timepoint: During labor and after delivery. Method of measurement: Researcher's designed form.</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>2020-05-26</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
