<?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>IRCT201111053034N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-07-21</date_registration>
      <primary_sponsor>Vice chancellor for research,Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effects of perineal massage on delivery outcome</public_title>
      <acronym></acronym>
      <scientific_title>The effects of perineal massage in active phase on delivery outcomes in nulliparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3020</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: During the second stage of labor. Condition 2: Episiotomy. Condition 3: Perineal outcomes. Condition 4: Urinary stress incontinence. Condition 5: Fecal incontinence. Condition 6: Intensity perineal pain.</hc_freetext>
      <i_freetext>Intervention 1: The researcher in the massage group out of sight and assist researchers in the active phase of labor and fetal head descent in the supine position and the zero position of 7-6 cm cervical dilatation until delivery, after-stained index finger and middle finger to the slider. Intervention 2: The control group with no intervention other than routine measures failed.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amene piri Galledar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Health Network, Farmandari Field, Imam Khomeini Avenue, Kuhdasht city</address>
        <city>Kuhdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68418-77479</zip>
        <telephone>+98 66 3622 3072</telephone>
        <email>Amene_ Piri@yahoo.com</email>
        <affiliation>Khuhdasht Health Network</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Iranian; no lesions on genitalia absence of any kind of diseases;  no sign of preeclampsia or eclampsia; live fetus; cephalic; singleton; maternal age 18-35; no dysparonia; no UTI and no practice during pregnancy. &#13;
Exclusion criteria: Subjects with Prolonged second stage of labor; precipitate labor (Labor that results in rapid expulsion of the fetus); pervious deliver by forceps of vacuum; Cesarean section; shoulders dystocia; or cephalo pelvic disproportion (c.p.d.); last baby weight less than 2500 kgr; And more than 4000 kgr; any change on address and telephone number were excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>063</hc_code>
      <hc_code>070</hc_code>
      <hc_code>070.0,070.</hc_code>
      <hc_code>N39.3</hc_code>
      <hc_code>M62.9</hc_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>prolong second stage of labor</hc_keyword>
      <hc_keyword>episiotomy extended by laceration</hc_keyword>
      <hc_keyword>Fourth degree perineal laceration during delivery,Third degree perineal laceration during delivery,Second degree perineal laceration during delivery,First degree perineal laceration during delivery</hc_keyword>
      <hc_keyword>Use additional code (N32.8), if desired, to identify overactive bladder or detrusor muscle hyperactivity</hc_keyword>
      <hc_keyword>Disorder of muscle, unspecified</hc_keyword>
      <hc_keyword>Complication of labour and delivery, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The researcher in the massage group out of sight and assist researchers in the active phase of labor and fetal head descent in the supine position and the zero position of 7-6 cm cervical dilatation until delivery, after-stained index finger and middle finger to the slider</i_keyword>
      <i_keyword>The control group with no intervention other than routine measures failed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Focal incontinence. Timepoint: Three months after delivery. Method of measurement: Question.</prim_outcome>
      <prim_outcome>Urinary stress incontinence. Timepoint: Three months after delivery. Method of measurement: Question.</prim_outcome>
      <prim_outcome>Perineal out come. Timepoint: after intervention. Method of measurement: observation.</prim_outcome>
      <prim_outcome>During the second stage of labor. Timepoint: after prevention. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Intensity perineal pain. Timepoint: 3 day and 10 day after delivery. Method of measurement: visual analouge scale.</prim_outcome>
      <prim_outcome>Episiotomy. Timepoint: after delivery. Method of measurement: observation.</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>Vice chancellor for research,Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-07-21</approval_date>
        <contact_name>School of Nursing and Midwifery,Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid field, Nosrat-e SHarghi avenue Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
