<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/NCT04441125</url>
  </required_header>
  <id_info>
    <org_study_id>76</org_study_id>
    <nct_id>NCT04441125</nct_id>
  </id_info>
  <brief_title>The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding</brief_title>
  <official_title>The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi</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>
      Aim: This study has been planned as an observational study. The aim of this study is to&#xD;
      determine the effect of labor induction with oxytocin on early postpartum hemorrhage,&#xD;
      perineal integrity and breastfeeding.&#xD;
&#xD;
      Materials and Methods:&#xD;
&#xD;
      The sample consists of 88 healthy mother and infant pairs. The mothers in the case group will&#xD;
      receive oxytocin induction before and after delivery. On the other hand, the mothers in the&#xD;
      control group will not receive any oxytocin induction before delivery, and will receive&#xD;
      oxytocin induction in the end of delivery.&#xD;
&#xD;
      Data were collected by using the Personal Information Form, the LATCH Breastfeeding&#xD;
      Diagnostic Scale, the Breastfeeding Self-Efficacy Scale, the follow-up bag for postpartum&#xD;
      hemorrhage, and episiotomy healing assessment known as the REEDA Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxytocin is applied to the women in the case group before the delivery.&#xD;
&#xD;
      There is a procedure on the usage of oxytocin at the delivery room. In accordance with the&#xD;
      relevant procedure, it is administered as an intravenous infusion by adding 5 units of&#xD;
      oxytocin in 500 cc of physiological saline solution.&#xD;
&#xD;
      The initial dosage is adjusted in order to allow for the flow of 4 drops per minute. Maximum&#xD;
      40 drops in total can be applied by increasing for 4 drops every 20 minutes. The dosage can&#xD;
      be increased by considering the intensity and duration of contractions. The initial dosage of&#xD;
      the oxytocin procedure applied to the women is the same for all women. As the total duration&#xD;
      of delivery is different, there are differences between the dosages of oxytocin received.&#xD;
&#xD;
      In accordance with the postpartum procedure at the delivery room, it is administered as an&#xD;
      intravenous infusion to all women (primiparous, multiparous) by adding 20 units of oxytocin&#xD;
      in 500 cc of physiological saline solution immediately after the delivery.&#xD;
&#xD;
      The women in the control group do not receive any oxytocin induction before the delivery, and&#xD;
      these women give birth spontaneously. After the delivery, the postpartum procedure applied&#xD;
      for the control group is preferred.&#xD;
&#xD;
      Episiotomy is applied routinely to the primiparous pregnant women at the gynecological&#xD;
      examination table in order to enlarge the opening of the vagina during the delivery.&#xD;
      Episiotomy is a surgical incision applied to the bulbo-cavernous muscle in the perineal&#xD;
      region while the baby's head appears in order to protect the perineal tonus, prevent&#xD;
      undesired repairs, and to provide an easy, quick and safe delivery by enlarging the vaginal&#xD;
      opening. Medio-lateral episiotomy is applied routinely to all women.&#xD;
&#xD;
      Immediately after the delivery, the baby's umbilical cord is clamped and cut. The postpartum&#xD;
      hemorrhage bag is placed under the mother's perineal region immediately after the umbilical&#xD;
      cord is cut, and it is waited for separation of the placenta. The duration for separation of&#xD;
      the placenta is 30 minutes in maximum. After separation of the placenta, episiotomy repair is&#xD;
      made. The loss of blood in the postpartum hemorrhage bag is recorded after the episiotomy&#xD;
      repair. Before the woman is taken to her bed, necessary pads are provided, postpartum&#xD;
      hemorrhage is followed-up, and the pads are weighed in the 24th postpartum hour.&#xD;
&#xD;
      The perineal region is evaluated by the REEDA scale in the postpartum 12th hour and the&#xD;
&#xD;
      The LATCH, the Breastfeeding Assessment, and the BSES are applied in the postpartum 24th hour&#xD;
      and the first week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">September 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)</measure>
    <time_frame>12th hour</time_frame>
    <description>Assessment is made by giving 0, 1, 2 and 3 scores to each title in the scale, and 0 is the lowest score and 15 is the highest score. 0 is the normal value for total score. In the scale, an increase in score indicates that there is pathology, and a decrease in score indicates that there is a recovery.&#xD;
The REEDA score is evaluated in the 12th hour after delivery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Breastfeeding Self-Efficacy Scale(BSES)</measure>
    <time_frame>24th hour</time_frame>
    <description>This form is a five-point Likert-type scale, and it is scored as follows: &quot;1=not at all confident&quot;, &quot;2=not very confident&quot;, &quot;3=sometimes confident&quot;, &quot;4=confidentˮ, &quot;5=very confidentˮ.&#xD;
The Breastfeeding Self-Efficacy Scale consists of 14 items.&#xD;
The lowest score which can be achieved from the scale is 14, and the highest score is 70.&#xD;
Achieving a high score indicates that the mothers have a high breastfeeding self-efficacy.&#xD;
The Breastfeeding Self-Efficacy is evaluated in the 24th hour after delivery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni</measure>
    <time_frame>24th hour</time_frame>
    <description>The LATCH: It consists of five evaluation criteria.&#xD;
Each item is evaluated between the score range of &quot;0 - 2ˮ. In the scale, the highest score which can be achieved is 10, and the lowest score is 0. As the score achieved from this scale increases, the success in breastfeeding increases.&#xD;
The LATCH score is evaluated in the 24th hour after delivery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Follow-up Bag for Postpartum Hemorrhage(postpartum blood bag +pad weigth )</measure>
    <time_frame>24th hour</time_frame>
    <description>The postpartum hemorrhage bag has been calibrated in order to help for the follow-up of vaginal hemorrhage and fluid, and has been designed as filtration-specific. The bag is transparent colored, and the amount within the bag is recorded as milliliter.The postpartum hemorrhage bag is placed under the mother's perineal region after the delivery in order to measure the postpartum hemorrhage, and the amount of hemorrhage is recorded when the mother leaves the gynecological table. Then, the hemorrhage follow-up is made through a pad when the mother is taken to the bed. All pads are sterile and same in size. In the 24th postpartum hour, the pads used by the researcher are weighed and recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)</measure>
    <time_frame>24th hour</time_frame>
    <description>Assessment is made by giving 0, 1, 2 and 3 scores to each title in the scale, and 0 is the lowest score and 15 is the highest score. 0 is the normal value for total score. In the scale, an increase in score indicates that there is pathology, and a decrease in score indicates that there is a recovery.&#xD;
The REEDA score is evaluated in the 24th hour after delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Breastfeeding Self-Efficacy Scale(BSES)</measure>
    <time_frame>The first week</time_frame>
    <description>This form is a five-point Likert-type scale, and it is scored as follows: &quot;1=not at all confident&quot;, &quot;2=not very confident&quot;, &quot;3=sometimes confident&quot;, &quot;4=confidentˮ, &quot;5=very confidentˮ.&#xD;
The Breastfeeding Self-Efficacy Scale consists of 14 items.&#xD;
The lowest score which can be achieved from the scale is 14, and the highest score is 70.&#xD;
Achieving a high score indicates that the mothers have a high breastfeeding self-efficacy.&#xD;
The Breastfeeding Self-Efficacy is evaluated in the first week after delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni</measure>
    <time_frame>The first week</time_frame>
    <description>The LATCH: It consists of five evaluation criteria.&#xD;
Each item is evaluated between the score range of &quot;0 - 2ˮ. In the scale, the highest score which can be achieved is 10, and the lowest score is 0. As the score achieved from this scale increases, the success in breastfeeding increases.&#xD;
The LATCH score is evaluated in the first week after delivery.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Oxytocin</condition>
  <arm_group>
    <arm_group_label>case group</arm_group_label>
    <description>The mothers in the case group will receive oxytocin induction before and after delivery(n:44).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>The mothers in the control group will not receive any oxytocin induction before delivery, and will receive oxytocin induction in the end of delivery(n:44)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study consists of the primiparous pregnant women who comply with the study criteria,&#xD;
        accept the study, and who are hospitalized in the delivery unit at Zeynep Kamil Women and&#xD;
        Children Diseases Training and Research Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-35 years,&#xD;
&#xD;
          -  having a single pregnancy,&#xD;
&#xD;
          -  literate,&#xD;
&#xD;
          -  between 37-42 gestational week,&#xD;
&#xD;
          -  hemoglobin level of 10 g and above,&#xD;
&#xD;
          -  without chronic, mental and psychological disease&#xD;
&#xD;
        Infants;&#xD;
&#xD;
          -  without congenital anomalies,&#xD;
&#xD;
          -  with a first Apgar score of 8 and above,&#xD;
&#xD;
          -  birth weight between 2500 - 4000 g&#xD;
&#xD;
          -  no obstruction to oral feeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiparity,&#xD;
&#xD;
          -  any risky condition development in the mother and baby during or after birth&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women aged 18-35 years, having a single pregnancy, literate, between 37-42 gestational week, hemoglobin level of 10 g and above, without chronic, mental and psychological disease were included in the study. Infants without congenital anomalies, with a first Apgar score of 8 and above, birth weight between 2500- 4000 g and no obstruction to oral feeding constituted the sample of the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>YASEMİN AYDIN KARTAL, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zeynep Kamil Women's and Children's Diseases Training and Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34668</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>YASEMİN AYDIN KARTAL</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Perineal Integrity</keyword>
  <keyword>Postpartum Hemorrhage</keyword>
  <keyword>oxytocin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04441125
org study id: 76
nct id: NCT04441125
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: This study has been planned as an observational study. The aim of this study is to
      determine the effect of labor induction with oxytocin on early postpartum hemorrhage,
      perineal integrity and breastfeeding.

      Materials and Methods:

      The sample consists of 88 healthy mother and infant pairs. The mothers in the case group will
      receive oxytocin induction before and after delivery. On the other hand, the mothers in the
      control group will not receive any oxytocin induction before delivery, and will receive
      oxytocin induction in the end of delivery.

      Data were collected by using the Personal Information Form, the LATCH Breastfeeding
      Diagnostic Scale, the Breastfeeding Self-Efficacy Scale, the follow-up bag for postpartum
      hemorrhage, and episiotomy healing assessment known as the REEDA Scale.
Oxytocin is applied to the women in the case group before the delivery.

      There is a procedure on the usage of oxytocin at the delivery room. In accordance with the
      relevant procedure, it is administered as an intravenous infusion by adding 5 units of
      oxytocin in 500 cc of physiological saline solution.

      The initial dosage is adjusted in order to allow for the flow of 4 drops per minute. Maximum
      40 drops in total can be applied by increasing for 4 drops every 20 minutes. The dosage can
      be increased by considering the intensity and duration of contractions. The initial dosage of
      the oxytocin procedure applied to the women is the same for all women. As the total duration
      of delivery is different, there are differences between the dosages of oxytocin received.

      In accordance with the postpartum procedure at the delivery room, it is administered as an
      intravenous infusion to all women (primiparous, multiparous) by adding 20 units of oxytocin
      in 500 cc of physiological saline solution immediately after the delivery.

      The women in the control group do not receive any oxytocin induction before the delivery, and
      these women give birth spontaneously. After the delivery, the postpartum procedure applied
      for the control group is preferred.

      Episiotomy is applied routinely to the primiparous pregnant women at the gynecological
      examination table in order to enlarge the opening of the vagina during the delivery.
      Episiotomy is a surgical incision applied to the bulbo-cavernous muscle in the perineal
      region while the baby's head appears in order to protect the perineal tonus, prevent
      undesired repairs, and to provide an easy, quick and safe delivery by enlarging the vaginal
      opening. Medio-lateral episiotomy is applied routinely to all women.

      Immediately after the delivery, the baby's umbilical cord is clamped and cut. The postpartum
      hemorrhage bag is placed under the mother's perineal region immediately after the umbilical
      cord is cut, and it is waited for separation of the placenta. The duration for separation of
      the placenta is 30 minutes in maximum. After separation of the placenta, episiotomy repair is
      made. The loss of blood in the postpartum hemorrhage bag is recorded after the episiotomy
      repair. Before the woman is taken to her bed, necessary pads are provided, postpartum
      hemorrhage is followed-up, and the pads are weighed in the 24th postpartum hour.

      The perineal region is evaluated by the REEDA scale in the postpartum 12th hour and the

      The LATCH, the Breastfeeding Assessment, and the BSES are applied in the postpartum 24th hour
      and the first week.
observational model: Other
time perspective: Other
measure: The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)
time frame: 12th hour
description: Assessment is made by giving 0, 1, 2 and 3 scores to each title in the scale, and 0 is the lowest score and 15 is the highest score. 0 is the normal value for total score. In the scale, an increase in score indicates that there is pathology, and a decrease in score indicates that there is a recovery.
The REEDA score is evaluated in the 12th hour after delivery.
measure: The Breastfeeding Self-Efficacy Scale(BSES)
time frame: 24th hour
description: This form is a five-point Likert-type scale, and it is scored as follows: "1=not at all confident", "2=not very confident", "3=sometimes confident", "4=confidentˮ, "5=very confidentˮ.
The Breastfeeding Self-Efficacy Scale consists of 14 items.
The lowest score which can be achieved from the scale is 14, and the highest score is 70.
Achieving a high score indicates that the mothers have a high breastfeeding self-efficacy.
The Breastfeeding Self-Efficacy is evaluated in the 24th hour after delivery.
measure: L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni
time frame: 24th hour
description: The LATCH: It consists of five evaluation criteria.
Each item is evaluated between the score range of "0 - 2ˮ. In the scale, the highest score which can be achieved is 10, and the lowest score is 0. As the score achieved from this scale increases, the success in breastfeeding increases.
The LATCH score is evaluated in the 24th hour after delivery.
measure: The Follow-up Bag for Postpartum Hemorrhage(postpartum blood bag +pad weigth )
time frame: 24th hour
description: The postpartum hemorrhage bag has been calibrated in order to help for the follow-up of vaginal hemorrhage and fluid, and has been designed as filtration-specific. The bag is transparent colored, and the amount within the bag is recorded as milliliter.The postpartum hemorrhage bag is placed under the mother's perineal region after the delivery in order to measure the postpartum hemorrhage, and the amount of hemorrhage is recorded when the mother leaves the gynecological table. Then, the hemorrhage follow-up is made through a pad when the mother is taken to the bed. All pads are sterile and same in size. In the 24th postpartum hour, the pads used by the researcher are weighed and recorded.
measure: The REEDA (Redness, Oedema, Ecchymosis, Discharge and Approximation)
time frame: 24th hour
description: Assessment is made by giving 0, 1, 2 and 3 scores to each title in the scale, and 0 is the lowest score and 15 is the highest score. 0 is the normal value for total score. In the scale, an increase in score indicates that there is pathology, and a decrease in score indicates that there is a recovery.
The REEDA score is evaluated in the 24th hour after delivery.
measure: The Breastfeeding Self-Efficacy Scale(BSES)
time frame: The first week
description: This form is a five-point Likert-type scale, and it is scored as follows: "1=not at all confident", "2=not very confident", "3=sometimes confident", "4=confidentˮ, "5=very confidentˮ.
The Breastfeeding Self-Efficacy Scale consists of 14 items.
The lowest score which can be achieved from the scale is 14, and the highest score is 70.
Achieving a high score indicates that the mothers have a high breastfeeding self-efficacy.
The Breastfeeding Self-Efficacy is evaluated in the first week after delivery.
measure: L (LATCH on breast) A (Audible Swallowing) T (Type of Nipple) C (Comfort of Breast/Nipple) H (Hold/Positioni
time frame: The first week
description: The LATCH: It consists of five evaluation criteria.
Each item is evaluated between the score range of "0 - 2ˮ. In the scale, the highest score which can be achieved is 10, and the lowest score is 0. As the score achieved from this scale increases, the success in breastfeeding increases.
The LATCH score is evaluated in the first week after delivery.
arm group label: case group
description: The mothers in the case group will receive oxytocin induction before and after delivery(n:44).
arm group label: control group
description: The mothers in the control group will not receive any oxytocin induction before delivery, and will receive oxytocin induction in the end of delivery(n:44)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women aged 18-35 years, having a single pregnancy, literate, between 37-42 gestational week, hemoglobin level of 10 g and above, without chronic, mental and psychological disease were included in the study. Infants without congenital anomalies, with a first Apgar score of 8 and above, birth weight between 2500- 4000 g and no obstruction to oral feeding constituted the sample of the study.
minimum age: 18 Years
maximum age: 35 Years
last name: YASEMİN AYDIN KARTAL, PhD
role: Study Director
affiliation: Saglik Bilimleri Universitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: YASEMİN AYDIN KARTAL
investigator title: Associate professor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No