xml: <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/NCT06011096</url>
    </required_header>
    <id_info>
      <org_study_id>Erzurum Atatürk Üniversitesi</org_study_id>
      <nct_id>NCT06011096</nct_id>
    </id_info>
    <brief_title>The Effect of Skin-to-skin Contact on Placental Separation Time, Type, Postpartum Hemorrhage and Comfort</brief_title>
    <official_title>The Effect of Skin-to-Skin Contact and Delayed Cord Clampingon Placental Separation Time, Separation Method, Amount of Postpartum Bleeding and Postpartum Comfort</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bahar GÖBEL</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        It is aimed to determine the late cord clamping with early skin-to-skin contact in&#xD;
        primiparous pregnant women who delivered vaginally, according to placental separation time,&#xD;
        separation method, amount of postpartum bleeding and postpartum comfort.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research is an experimental type randomized controlled trial. The data of the research&#xD;
        gathered in the delivery room clinic of Erzurum City Hospital affiliated to the Ministry of&#xD;
        Health in Erzurum city center between 02.11.2022 and 10.06.2023. The study was completed with&#xD;
        126 primiparous pregnants, 63 of whom were controls and 63 of whom were experimental,&#xD;
        randomized in the clinic. &quot;Personal Information Form&quot; and &quot;Postpartum Comfort Scale&quot; prepared&#xD;
        by the researcher were used to collect the data of the study.&#xD;
  &#xD;
        control group&#xD;
  &#xD;
          -  Pregnant women who met the criteria for admission to the delivery room were selected,&#xD;
             the institution's routine policies were implemented.&#xD;
  &#xD;
          -  The mother was informed about the study and written consent was obtained.&#xD;
  &#xD;
          -  Hospital routine practices continued until birth.&#xD;
  &#xD;
          -  The stopwatch is started the moment the baby is born.&#xD;
  &#xD;
          -  After birth, the umbilical cord was clamped immediately without skin-to-skin contact&#xD;
             between the mother and the baby, and the baby was taken to routine care.&#xD;
  &#xD;
          -  Signs of placental separation were monitored with a stopwatch, and it was noted at what&#xD;
             minute the symptoms were seen.&#xD;
  &#xD;
          -  Placental delivery time and separation type were noted in the relevant part of the form.&#xD;
  &#xD;
          -  According to the routines taken from each hospitalized patient in institutional&#xD;
             policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.&#xD;
  &#xD;
          -  The Personal Information Form consisting of 22 questions and the Postpartum Comfort&#xD;
             scale were administered to the mother at the end of the follow-up period in the delivery&#xD;
             room (2 hours later).&#xD;
  &#xD;
          -  From the 6th hour blood values found in the hospital routine, the mother's hemoglobin&#xD;
             and hematocrit values were noted on the form.&#xD;
  &#xD;
        Experimental group&#xD;
  &#xD;
          -  Pregnant women who met the criteria for admission to the delivery room were selected,&#xD;
             the institution's routine policies were implemented.&#xD;
  &#xD;
          -  The mother was informed about the study and written consent was obtained.&#xD;
  &#xD;
          -  Hospital routine practices continued until birth.&#xD;
  &#xD;
          -  The stopwatch is started the moment the baby is born.&#xD;
  &#xD;
          -  The baby was placed on the mother's chest, it was waited for 60-90 seconds in&#xD;
             skin-to-skin contact, and breastfeeding was tried. At the end of the period, the&#xD;
             umbilical cord was clamped and the baby was placed under a radiant heater and routine&#xD;
             care was continued.&#xD;
  &#xD;
          -  Signs of placental separation were monitored with a stopwatch, and it was noted at what&#xD;
             minute the symptoms were seen.&#xD;
  &#xD;
          -  Placental delivery time and separation type were noted in the relevant part of the form.&#xD;
  &#xD;
          -  According to the routines taken from each hospitalized patient in institutional&#xD;
             policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.&#xD;
  &#xD;
          -  During the repair of episiotomy or desuria, if any, in the mother, skin-to-skin contact&#xD;
             was made between the baby and the mother for 1 hour without disrupting the procedures.&#xD;
  &#xD;
          -  The Personal Information Form consisting of 22 questions and the Postpartum Comfort&#xD;
             scale were administered to the mother at the end of the follow-up period in the delivery&#xD;
             room (2 hours later).&#xD;
  &#xD;
          -  From the 6th hour blood values found in the hospital routine, the mother's hemoglobin&#xD;
             and hematocrit values were noted on the form.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 2, 2022</start_date>
    <completion_date type="Actual">August 9, 2023</completion_date>
    <primary_completion_date type="Actual">June 10, 2023</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skin-to-skin contact and delayed cord clamping affect placental separation time.</measure>
      <time_frame>0-30 minute</time_frame>
      <description>It shortens the placental separation time in women who have had a vaginal delivery with skin-to-skin contact and delayed clamping of the cord.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding.</measure>
      <time_frame>0-6 hours</time_frame>
      <description>Skin-to-skin contact and delayed cord clamping reduce the amount of postpartum hemorrhage in women who deliver vaginally.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin-to-skin contact and delayed cord clamping have no effect on the type of placental separation.</measure>
      <time_frame>0-30 minute</time_frame>
      <description>Determination of the effect of skin-to-skin contact and delayed cord clamping on the type of placental separation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin-to-skin contact and delayed cord clamping affect the level of postpartum comfort.</measure>
      <time_frame>2 hours</time_frame>
      <description>Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">126</enrollment>
    <condition>Patient Comfort</condition>
    <condition>Postpartum Hemorrhage</condition>
    <condition>Midwifery</condition>
    <condition>Placenta</condition>
    <arm_group>
      <arm_group_label>the group with skin-to-skin contact and delayed cord clamping</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The group without skin-to-skin contact and early cord clamping</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>skin-to-skin contact and delayed cord clamping</intervention_name>
      <description>Placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated with skin-to-skin contact and late cord clamping after delivery.</description>
      <arm_group_label>the group with skin-to-skin contact and delayed cord clamping</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>avoiding skin-to-skin contact and early cord clamping</intervention_name>
      <description>After delivery, placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated without skin-to-skin contact and late cord clamping.</description>
      <arm_group_label>The group without skin-to-skin contact and early cord clamping</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  for pregnant women&#xD;
  &#xD;
                 1. Those who agreed to participate in the research&#xD;
  &#xD;
                 2. 18-49 years old&#xD;
  &#xD;
                 3. Firstborn (nulliparous)&#xD;
  &#xD;
                 4. Have 37-42 weeks of pregnancy&#xD;
  &#xD;
                 5. The baby in head presentation&#xD;
  &#xD;
                 6. No prenatal risk pregnancy&#xD;
  &#xD;
                 7. No risk during and after birth&#xD;
  &#xD;
            -  for newborns&#xD;
  &#xD;
                 1. Absence of any health problems or congenital diseases,&#xD;
  &#xD;
                 2. No need for resuscitation after birth.&#xD;
  &#xD;
                 3. APGAR score of 8 points or more&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Births less than 37 weeks&#xD;
  &#xD;
            2. Multiparity&#xD;
  &#xD;
            3. Any complications in the mother or baby&#xD;
  &#xD;
            4. Removal of the placenta by intervention rather than spontaneous separation&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>primiparous women giving birth vaginally</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bahar Göbel</last_name>
      <role>Principal Investigator</role>
      <affiliation>Midwife</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Erzurum City Hospital</name>
        <address>
          <city>Erzurum</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Bahar GÖBEL</investigator_full_name>
      <investigator_title>Midwife</investigator_title>
    </responsible_party>
    <keyword>skin-to-skin contact</keyword>
    <keyword>placental separation time</keyword>
    <keyword>Postpartum Comfort</keyword>
    <keyword>placental separation method</keyword>
    <keyword>delayed clamping of the umbilical cord</keyword>
    <keyword>midwife</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postpartum Hemorrhage</mesh_term>
      <mesh_term>Abruptio Placentae</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011096
  org study id: Erzurum Atatürk Üniversitesi
  nct id: NCT06011096
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It is aimed to determine the late cord clamping with early skin-to-skin contact in
        primiparous pregnant women who delivered vaginally, according to placental separation time,
        separation method, amount of postpartum bleeding and postpartum comfort.
  The research is an experimental type randomized controlled trial. The data of the research
        gathered in the delivery room clinic of Erzurum City Hospital affiliated to the Ministry of
        Health in Erzurum city center between 02.11.2022 and 10.06.2023. The study was completed with
        126 primiparous pregnants, 63 of whom were controls and 63 of whom were experimental,
        randomized in the clinic. "Personal Information Form" and "Postpartum Comfort Scale" prepared
        by the researcher were used to collect the data of the study.
  
        control group
  
          -  Pregnant women who met the criteria for admission to the delivery room were selected,
             the institution's routine policies were implemented.
  
          -  The mother was informed about the study and written consent was obtained.
  
          -  Hospital routine practices continued until birth.
  
          -  The stopwatch is started the moment the baby is born.
  
          -  After birth, the umbilical cord was clamped immediately without skin-to-skin contact
             between the mother and the baby, and the baby was taken to routine care.
  
          -  Signs of placental separation were monitored with a stopwatch, and it was noted at what
             minute the symptoms were seen.
  
          -  Placental delivery time and separation type were noted in the relevant part of the form.
  
          -  According to the routines taken from each hospitalized patient in institutional
             policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.
  
          -  The Personal Information Form consisting of 22 questions and the Postpartum Comfort
             scale were administered to the mother at the end of the follow-up period in the delivery
             room (2 hours later).
  
          -  From the 6th hour blood values found in the hospital routine, the mother's hemoglobin
             and hematocrit values were noted on the form.
  
        Experimental group
  
          -  Pregnant women who met the criteria for admission to the delivery room were selected,
             the institution's routine policies were implemented.
  
          -  The mother was informed about the study and written consent was obtained.
  
          -  Hospital routine practices continued until birth.
  
          -  The stopwatch is started the moment the baby is born.
  
          -  The baby was placed on the mother's chest, it was waited for 60-90 seconds in
             skin-to-skin contact, and breastfeeding was tried. At the end of the period, the
             umbilical cord was clamped and the baby was placed under a radiant heater and routine
             care was continued.
  
          -  Signs of placental separation were monitored with a stopwatch, and it was noted at what
             minute the symptoms were seen.
  
          -  Placental delivery time and separation type were noted in the relevant part of the form.
  
          -  According to the routines taken from each hospitalized patient in institutional
             policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.
  
          -  During the repair of episiotomy or desuria, if any, in the mother, skin-to-skin contact
             was made between the baby and the mother for 1 hour without disrupting the procedures.
  
          -  The Personal Information Form consisting of 22 questions and the Postpartum Comfort
             scale were administered to the mother at the end of the follow-up period in the delivery
             room (2 hours later).
  
          -  From the 6th hour blood values found in the hospital routine, the mother's hemoglobin
             and hematocrit values were noted on the form.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Outcomes Assessor)
  measure: Skin-to-skin contact and delayed cord clamping affect placental separation time.
  time frame: 0-30 minute
  description: It shortens the placental separation time in women who have had a vaginal delivery with skin-to-skin contact and delayed clamping of the cord.
  measure: Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding.
  time frame: 0-6 hours
  description: Skin-to-skin contact and delayed cord clamping reduce the amount of postpartum hemorrhage in women who deliver vaginally.
  measure: Skin-to-skin contact and delayed cord clamping have no effect on the type of placental separation.
  time frame: 0-30 minute
  description: Determination of the effect of skin-to-skin contact and delayed cord clamping on the type of placental separation.
  measure: Skin-to-skin contact and delayed cord clamping affect the level of postpartum comfort.
  time frame: 2 hours
  description: Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.
  arm group label: the group with skin-to-skin contact and delayed cord clamping
  arm group type: Experimental
  description: In this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby.
  arm group label: The group without skin-to-skin contact and early cord clamping
  arm group type: Experimental
  description: In this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby.
  intervention type: Other
  intervention name: skin-to-skin contact and delayed cord clamping
  description: Placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated with skin-to-skin contact and late cord clamping after delivery.
  arm group label: the group with skin-to-skin contact and delayed cord clamping
  intervention type: Other
  intervention name: avoiding skin-to-skin contact and early cord clamping
  description: After delivery, placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated without skin-to-skin contact and late cord clamping.
  arm group label: The group without skin-to-skin contact and early cord clamping
  criteria: 
  gender: Female
  gender based: Yes
  gender description: primiparous women giving birth vaginally
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bahar Göbel
  role: Principal Investigator
  affiliation: Midwife
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ataturk University
  investigator full name: Bahar GÖBEL
  investigator title: Midwife
  mesh term: Postpartum Hemorrhage
  mesh term: Abruptio Placentae
  mesh term: Hemorrhage