<?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>IRCT2013090314556N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-10</date_registration>
      <primary_sponsor>Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Prineal Massage on Prineal Trauma</public_title>
      <acronym></acronym>
      <scientific_title>The effect of preineal massage in second stage of labor on preineal trauma, episiotomy and its outcomes among nuliparous women referred to delivery ward of Beasat hospital, 2013.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14167</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>Delivery.</hc_freetext>
      <i_freetext>Intervention 1: There is not any intervention for control group and after child birth perineal and vagina will be checked and determined perineal rupture and episiotomy rate. Post natal care will be performed for all mothers. For assessing perineal pain and its intensity all mothers will be followup 3 and 10 days during post postpartum. Intervention 2: Researcher during second stage of childbirth (from full dilatation till expulsion of fetal head) put gloves and with K vay Jell , perineal will be massage between 3 and 9 area of vagina gently for 30 minutes. After childbirth perineal will be checked for rupture and episiotomy rate. During postpartum , 3 and 10 days after birth mother will be evaluated for perineal pain and its intensity.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>The Effect of Perineal Massage during the Second Stage of Birth on Perineal Lacerations, Episiotomy, and Perineal Pain in Nulliparous Women &lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Introduction: Childbirth and puerperium are of the most important periods in women’s life and can affect different aspects of their life . Although childbirth is a physiological process, there is a risk of perineal trauma when neonate’s head is exiting, and thus, an episiotomy may be needed. This study was conducted to determine the effect of perineal massage in the second stage of labor on perineal lacerations, episiotomy, and perineal pain in nulliparous women going to childbirth unit of Besat Hospital in Sanandaj, Iran.&lt;br /&gt;&#13;
Material &amp; Methods: The study population included all nulliparous women going to childbirth unit of Besat Hospital in 2013-2014. The participants were selected through convenience sampling and randomly assigned to groups such that nulliparous women with inclusion criteria were alternately assigned to the case and control groups. All of them were taught about postpartum perineal pain and its severity, and the researcher followed them up 3 days, 10 days, and 3 months after childbirth by telephone.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Results: The results showed mean and standard deviation of the participants in the case group (receiving perineal massage) as 25.62 ± 4.25 years and those in the control group as 25.31 ± 3.86 years. The participants in both groups were mostly 21-25 years old. The results revealed 23.16% of first-degree perineal laceration and 2.11% of second-degree perineal laceration in the case group, and no vestibular laceration and third- and fourth-degree lacerations in the case group. However, there were 5.13% of vestibular laceration, 7.69% of first-degree laceration, 2.56% of second-degree laceration, and 1.05% of third-degree laceration (one woman) in the control group.&lt;br /&gt;&#13;
 Based on the results, the postpartum perineal pain was different in both group. Comparison of degrees of pain in the two groups showed that the severity of pain 3 days and 3 months after childbirth was significant (P = 0.01 &amp; P = 0.008, respectively), but the severity of pain in the 10th day did not differ significantly (P = 0.78) (Table 5). The results on frequency of complications did not show any significant difference between groups (P = 0.413).&lt;br /&gt;&#13;
</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>Roonak Shahoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj - Kurdistan _ Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66166</zip>
        <telephone>+98 87 1666 1120</telephone>
        <email>roonak.shahoei@muk.ac.ir; rshaho@yahoo.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roonak Shahoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj - Kurdistan _ Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66166</zip>
        <telephone>+98 87 1666 1120</telephone>
        <email>roonak.shahoei@muk.ac.ir; rshaho@yahoo.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: nuliparity with gestational age 38-42 weeks; singleton; cephalic presentation; without PROM; placenta abruption; cephalo pelvic disproportion; fetal distress; do not have vaginal infections and herpes; do not have kegel exercise and professional sport.&#13;
Exclusion criteria: failure in progress; fetal distress; getting sedative; getting oxytocin; having operative delivery; being red rush and prineal edema; mother request for  disconnect the massage; need to cesarean; shoulder dystocia; occiput posterior; baby more than 4000 gram or below 2500.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Single spontaneous delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>There is not any intervention for control group and after child birth perineal and vagina will be checked and determined perineal rupture and episiotomy rate. Post natal care will be performed for all mothers. For assessing perineal pain and its intensity all mothers will be followup 3 and 10 days during post postpartum.</i_keyword>
      <i_keyword>Researcher during second stage of childbirth (from full dilatation till expulsion of fetal head) put gloves and with K vay Jell , perineal will be massage between 3 and 9 area of vagina gently for 30 minutes. After childbirth perineal will be checked for rupture and episiotomy rate. During postpartum , 3 and 10 days after birth mother will be evaluated for perineal pain and its intensity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Doing episiotomy. Timepoint: During delivery. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Safe prieneal. Timepoint: During delivery. Method of measurement: Prieneal examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Prineal trauma. Timepoint: After delivery. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Prineal pain. Timepoint: 3 and 10 days after delivery and 3 months after delivery. Method of measurement: Pain questioner.</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>Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-09-23</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Sanandaj - Kurdistan _ Iran Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
