<?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>IRCT201507022248N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-19</date_registration>
      <primary_sponsor>Vice Chancellor for research of the international branch of Iran University of Medical science</primary_sponsor>
      <public_title>Effect of Evening  Primrose  Oil on cervical ripening and pregnancy outcomes</public_title>
      <acronym></acronym>
      <scientific_title>The  effect  of oral  Evening  Primrose  Oil on cervical ripening and pregnancy outcomes in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1889</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: People  will be allocated randomly in one of two groups primrose capsules and placebo.At  first, the  names of each of the two groups are written on paper and placed in a separate envelope. The first  will be removed one of the envelopes the next person will be in the other group and again, the third will be removed one of the envelopes the next person will be in the other group. In this way people will be located in one of two groups until the completion of the sample size .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ripening of cervix.</hc_freetext>
      <i_freetext>Intervention 1: Oral Evening primrose capsules, from (40 weeks) to ( 40 +6 weeks) , 2 capsules of1000 mg every 12 hours daily for a week ( Manufacturing by Traditional Medicine Research Center Shahed University). Intervention 2: Placebo capsule containing gelatin, 50 mg, 2 capsules every 12 hours daily for a week ( Manufacturing by Traditional Medicine Research Center Shahed University).</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>mahnaz kalati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, shahid Hemmat Highway (next to Milad Tower)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8670 2031</telephone>
        <email>mahnazkalati77@yahoo.com</email>
        <affiliation>The international branch of Iran University of Medical Sciences and Heath</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshte Jahdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the Mottahari hospital, Rashid yasmi street, Valiasr avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8888 2886</telephone>
        <email>jahdi.fr@gmail.com</email>
        <affiliation>School of Nursing and Midwifery, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterias: cephalic presentation; alive fetus; with gestational age 40 weeks to (40 weeks + 6 days) based on LMP or ultrasound in first trimester; Normal patterns of fetal heart rate; Without uterine contractions; cervical bishop score less than 4 intact membranous; Maternal height more than 150 cm; non-addicted persons; normal adjusted BPP at the time of inclusion;An ultrasound of the placental grading;weight of fetus between 2500-4000 grams based on physical examination or ultrasonography; Low-risk pregnancy ( have no known surgical and internal disease or pregnancy complication such as previa, abruption, preeclampsia , no known fetal problems;Avoiding the enema, Intercourse, laxatives, the use of herbal medicines, chemical or traditional methods for induction of labor; Lack of vaginal examination 24 hours before the begining till end of the study; Exclusion criterias: appears possible side effects of drugs such as headache, nausea, diarrhea and etc, those who consume them is less than two capsule per day,  withdrew from the partnership at any stage of the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O60-O75</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Oral Evening primrose capsules, from (40 weeks) to ( 40 +6 weeks) , 2 capsules of1000 mg every 12 hours daily for a week ( Manufacturing by Traditional Medicine Research Center Shahed University)</i_keyword>
      <i_keyword>Placebo capsule containing gelatin, 50 mg, 2 capsules every 12 hours daily for a week ( Manufacturing by Traditional Medicine Research Center Shahed University)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ripening Of cervix. Timepoint: During the first week of intervention and labor. Method of measurement: bishop score Table.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of first، second and third stages of labor. Timepoint: During the first week of intervention and labor. Method of measurement: chronometer/Examination /check list/observation.</sec_outcome>
      <sec_outcome>Type of delivery. Timepoint: During the first week of intervention and labor. Method of measurement: End of study/observation.</sec_outcome>
      <sec_outcome>Infant apgar score. Timepoint: first and fifth minute after delivery. Method of measurement: 7 and more, under 7(According to  Apgar table).</sec_outcome>
      <sec_outcome>Neonatal transport to NICU. Timepoint: During the first 24 hours after childbirth. Method of measurement: check list.</sec_outcome>
      <sec_outcome>Induction. Timepoint: During the labor. Method of measurement: check list/observation.</sec_outcome>
      <sec_outcome>The duration of using oxytocin in the active phase. Timepoint: During  labor. Method of measurement: chronometer/check list/observation.</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 the international branch of Iran University of Medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-06</approval_date>
        <contact_name>Ethics committee of the Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat freeway (beside Milad Tower), Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
