<?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>IRCT2014011814556N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-19</date_registration>
      <primary_sponsor>Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of perineal massage during pregnancy on perineal trauma and postnatal pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of perineal massage during pregnancy on perineal trauma and postnatal pain among women referred to Beasat Hospital, Sanandaj</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14168</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prieneal complication.</hc_freetext>
      <i_freetext>Intervention 1: First of all researcher selected one of the midwife who work in beast hospital as co worker and teach her about preneal massage , choosing sample , filling consent form and questioner. Then co-worker teach the case group about preneal massage and will wanted them to use this massage from 34 weeks of pregnancy every day for 8 minutes in the shape of U between 3 to 9 clock of vagina with olive oil. Intervention 2: There is not any instruction and recommend for preneal massage during pregnancy for control group.</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;
Conclusion: Regarding the results of this study and those of other studies, perineal massage during the second stage of labor can reduce the need to episiotomy, perineal injuries, and perineal pain.&lt;br /&gt;&#13;
Keywords: Perineal massage, Nuliparous, Laceration, Episiotomy, Second stage&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>+98 918 666 1120</telephone>
        <email>rshaho@yahoo.comroonak.shahoei@muk.ac.ir</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>rshaho@yahoo.comroonak.shahoei@muk.ac.ir</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria are: pregnant women with gestational age between 38-42 weeks, singleton, cephalic who refereed to delivery ward of Beaset hospital in Sanandaj and had perineal massage from 34 week of pregnancy.&#13;
Exclusion criteria are: multiple pregnancy, cesarean history, using forceps or vacuum for delivery,using oxytocin,  shoulder dystocia, occiput posterior, macrosomy, preterm rupture of membranes, pelvic dystocia, placenta abruption, fetal distress,  using sedative and failure of progress.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>070</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First of all researcher selected one of the midwife who work in beast hospital as co worker and teach her about preneal massage , choosing sample , filling consent form and questioner. Then co-worker teach the case group about preneal massage and will wanted them to use this massage from 34 weeks of pregnancy every day for 8 minutes in the shape of U between 3 to 9 clock of vagina with olive oil.</i_keyword>
      <i_keyword>There is not any instruction and recommend for preneal massage during pregnancy for control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perineal tear. Timepoint: after delivery. Method of measurement: using questioner and examination after delivery.</prim_outcome>
    </primary_outcome>
    <secondary_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>2014-03-05</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_review>
        <status>Approved</status>
        <approval_date>2014-03-05</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>
