<?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>IRCT2014061818135N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-02</date_registration>
      <primary_sponsor>Research Council of Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of early maternal complications of episiotomy repair  with  Rapid  vicryl and chromic catgut in the primiparous women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of early maternal complications of episiotomy repair  with  Rapid  vicryl and chromic catgut in the primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16539</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Episiotomy repaire.</hc_freetext>
      <i_freetext>Intervention 1: IN intervention group episiotomy repaired with rapid vicryl then aerly maternal morbidity including perineal pain assessment whith visual analog scale and episiotomy wound healing assessment with reeda scale in 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum and 6 weeks postpartum.  Then the incidens of complications compaired with control group. Intervention 2: In control group episiotomy repaired with choromic catgut then early maternal morbidity including perineal pain assessment with visual anaiog scale and episiotomy wound healing assessment with reeda scale in 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum and 6 weeks postpartum. Then the incidens of complications compaired with intervention group.</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>Pouran allahbakhshi nasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Centeral bilding , Zand avenue, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1978-71345</zip>
        <telephone>+98 71 1455 0235</telephone>
        <email>allahbakhshi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara azima</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1978-71345</zip>
        <telephone>+98 71 1647 4252</telephone>
        <email>azimas@sums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: term pregnancy; singleton; Vertex presentation; Age 18-35 years; primiparous; no special diet; lack of specific diseases (anemia, cardiovascular disease, diabetes, immune disorders, liver disease, depression, lack of clotting disorders, preeclampsia and Infectious Diseases);  non smoking, alcohol and drugs; BMI less than 27&#13;
 Exclusion criteria: disorder of delivery (prolonged labor and dystocia steps); extention of episiotomy;  heavy bleeding after delivery (over 500 cc); use Vacium; further manipulating the perineum after childbirth; persistent constipation after childbirth; a serious and long-lasting pain after delivery; hematoma; fever and chills after delivery; macrosomia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>090. 1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Infection of obstetric surgical wound</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>IN intervention group episiotomy repaired with rapid vicryl then aerly maternal morbidity including perineal pain assessment whith visual analog scale and episiotomy wound healing assessment with reeda scale in 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum and 6 weeks postpartum.  Then the incidens of complications compaired with control group.</i_keyword>
      <i_keyword>In control group episiotomy repaired with choromic catgut then early maternal morbidity including perineal pain assessment with visual anaiog scale and episiotomy wound healing assessment with reeda scale in 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum and 6 weeks postpartum. Then the incidens of complications compaired with intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chromic catgut. Timepoint: 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum, 6 weeks postpartum. Method of measurement: Qualitative.</prim_outcome>
      <prim_outcome>Rapid vicryl. Timepoint: 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum, 6 weeks postpartum. Method of measurement: Qualitative.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wound healing. Timepoint: 24 hours, 3-5 days, 2 weeks, 6 weeks poste partume. Method of measurement: Reeda scale.</sec_outcome>
      <sec_outcome>Perineal pain. Timepoint: 24 hours postpartum, 3-5 days postpartum, 2weeks postpartum, 6 weeks postpartum. Method of measurement: Visual analog scale.</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>Research Council of Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-23</approval_date>
        <contact_name>Shiraz university of medical sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences, Zand Ave, Imam Hossein Square, Shiraz, Iran Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
