<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02201615</url>
  </required_header>
  <id_info>
    <org_study_id>SBF - 005</org_study_id>
    <secondary_id>GD01MD2958058</secondary_id>
    <nct_id>NCT02201615</nct_id>
  </id_info>
  <brief_title>The Effect of Perineal Massage in Childbirth</brief_title>
  <official_title>The Effect of Perineal Massage in Childbirth: the Rate of Episiotomy Procedures, Perineal Tears and the Length of the Second Stage of Labour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cumhuriyet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cumhuriyet University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective To examine the effects of perineal massage applied during the action of birth on&#xD;
      the frequency of episiotomy procedures, perineal tearing and the duration of the second stage&#xD;
      of birth.&#xD;
&#xD;
      Methods The present study was a randomized controlled experimental. Women (284 women) were&#xD;
      informed on the study and provided their written consent. 10-minute perineal massage with&#xD;
      glycerine was applied to the women in the test group for 4 times during the first stage and 1&#xD;
      time in the second stage of birth. The women in the control group received the routine care&#xD;
      procedure at the clinic.&#xD;
&#xD;
      Results According to the study findings, 31% of the women in the test group and 69.7% of the&#xD;
      women in the control group were made subject to episiotomy (p&lt;0.05). In the test and control&#xD;
      group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p&gt;0.05). The average&#xD;
      duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the&#xD;
      control group (p&lt;0.05).&#xD;
&#xD;
      Conclusion The study results indicate that perineal massage applied during the action of&#xD;
      birth decreased the rate of episiotomy procedure and shortened the duration of the second&#xD;
      stage of birth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <primary_completion_date type="Actual">May 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Episiotomy procedures</measure>
    <time_frame>until completed the second stage of labour, about from 30 min to 24 h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of the second stage of labour</measure>
    <time_frame>until completed the second stage of labour, about from 30 min to 24 h</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">284</enrollment>
  <condition>Obstetric Labor Complications</condition>
  <arm_group>
    <arm_group_label>Perineal Massage &amp; Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perineal Massage every 30 min, a 10 min 4 times in the first stage of labour, 1 times in the second stage of labour.&#xD;
Control routine care procedure at the clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perineal massage in childbirth</intervention_name>
    <arm_group_label>Perineal Massage &amp; Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With no pregnancy-related complications diagnosed during pregnancy,&#xD;
&#xD;
          -  No definitive indication for C-section,&#xD;
&#xD;
          -  Satisfying the pregnancy week in terms of the fetal dimensions,&#xD;
&#xD;
          -  At the 37th-42nd gestation week,&#xD;
&#xD;
          -  Applying to have her first or second birth,&#xD;
&#xD;
          -  With no systemic condition,&#xD;
&#xD;
          -  With head presentation,&#xD;
&#xD;
          -  At the latent phase of the first stage of birth with a dilatation under 4 cm and&#xD;
             effacement below 50%,&#xD;
&#xD;
          -  That have provided written consent specifying their voluntariness in participating in&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With pregnancy-related complications diagnosed during pregnancy,&#xD;
&#xD;
          -  Definitive indication for C-section,&#xD;
&#xD;
          -  No satisfying the pregnancy week in terms of the fetal dimensions,&#xD;
&#xD;
          -  At the &lt;37th- &gt;42nd gestation week,&#xD;
&#xD;
          -  With systemic condition,&#xD;
&#xD;
          -  With no head presentation,&#xD;
&#xD;
          -  At the latent phase of the first stage of birth with a dilatation above 4 cm&#xD;
&#xD;
          -  No have provided written consent specifying their voluntariness in participating in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cumhuriyet University</name>
      <address>
        <city>Sivas</city>
        <zip>58140</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cumhuriyet University</investigator_affiliation>
    <investigator_full_name>Gulbahtiyar DEMİREL</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Perineal Massage; Episiotomy; Perineal Laceration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02201615
org study id: SBF - 005
secondary id: GD01MD2958058
nct id: NCT02201615
lead sponsor: 
has dmc: No
Objective To examine the effects of perineal massage applied during the action of birth on
      the frequency of episiotomy procedures, perineal tearing and the duration of the second stage
      of birth.

      Methods The present study was a randomized controlled experimental. Women (284 women) were
      informed on the study and provided their written consent. 10-minute perineal massage with
      glycerine was applied to the women in the test group for 4 times during the first stage and 1
      time in the second stage of birth. The women in the control group received the routine care
      procedure at the clinic.

      Results According to the study findings, 31% of the women in the test group and 69.7% of the
      women in the control group were made subject to episiotomy (p<0.05). In the test and control
      group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The average
      duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the
      control group (p<0.05).

      Conclusion The study results indicate that perineal massage applied during the action of
      birth decreased the rate of episiotomy procedure and shortened the duration of the second
      stage of birth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Episiotomy procedures
time frame: until completed the second stage of labour, about from 30 min to 24 h
measure: Length of the second stage of labour
time frame: until completed the second stage of labour, about from 30 min to 24 h
arm group label: Perineal Massage & Control
arm group type: Experimental
description: Perineal Massage every 30 min, a 10 min 4 times in the first stage of labour, 1 times in the second stage of labour.
Control routine care procedure at the clinic.
intervention type: Other
intervention name: Perineal massage in childbirth
arm group label: Perineal Massage & Control
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Cumhuriyet University
investigator full name: Gulbahtiyar DEMİREL
investigator title: Assistant Professor
mesh term: Obstetric Labor Complications