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/NCT06005831</url>
    </required_header>
    <id_info>
      <org_study_id>2020/14-02</org_study_id>
      <nct_id>NCT06005831</nct_id>
    </id_info>
    <brief_title>Uterine Fundus Pressure in Reduction of Cesarean Bleeding</brief_title>
    <official_title>Is Application of Uterine Fundus Pressure With a Sandbag Effective in Reduction of Cesarean Bleeding? A Prospective Case Control Stud</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Firat University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Firat 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>
        Uterine compression methods reduce the amount of postpartum bleeding. In our study, we&#xD;
        investigated the effect of fundal pressure, which will be created by a sandbag placed on the&#xD;
        abdomen, on reducing post-cesarean bleeding. Material and Methods: A total of 482 patients&#xD;
        who delivered by cesarean section (CS) in the Obstetrics Clinic of Fırat University Faculty&#xD;
        of Medicine between January 2021 and December 2021 were included in this prospective,&#xD;
        randomized, single-center study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 482 patients who gave birth by CS in the Obstetrics Clinic of Fırat University&#xD;
        Faculty of Medicine between 1 January 2021 and 31 December 2021 were included in the study.&#xD;
        Approval was obtained from the Ethics Committee of Fırat University for this prospective&#xD;
        randomized single-center study (Ethics committee date = 15.10.2020; decision no =&#xD;
        2020/14-02). The 482 patients who had CS were divided into two groups, control group (n =&#xD;
        246), weighted group (n = 236) was randomized. Each patient was followed up in our obstetrics&#xD;
        clinic until discharge from the hospital after surgery and the data were analyzed. The same&#xD;
        techniques were used in all surgical procedures in order not to create differences in terms&#xD;
        of surgical techniques and operation times that may affect intraoperative bleeding. However,&#xD;
        to minimize inter-operator variations, surgical procedures were performed by operators with&#xD;
        sufficient surgical experience.&#xD;
  &#xD;
        The standard sandbag used in our clinic was 20 × 20 × 3 cm3 in dimensions and 3 kg in weight.&#xD;
        Sandbags of the same standard were used for all patients. After the patient was taken to the&#xD;
        patient's bed, the uterine fundus was palpated, and then the sandbag was placed on the&#xD;
        abdomen, just above the fundus, in such a way as to apply pressure to the fundus. The sandbag&#xD;
        was kept on the abdomen for approximately 6 hours. During this period, the patient was&#xD;
        followed up frequently and care was taken not to change the position of the sandbag. Sandbags&#xD;
        were removed just before our patients were mobilized (approximately 6 hours). The sandbag was&#xD;
        placed on the same spot in each patient by the obstetric assistants in our author team. In&#xD;
        addition, preoperative and postoperative follow-ups and data acquisition and storage were&#xD;
        performed by the same team 2.1 Study Design&#xD;
  &#xD;
        It is a prospective, randomized, controlled single-center study.&#xD;
  &#xD;
        2.2 Inclusion Criteria&#xD;
  &#xD;
        All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the&#xD;
        study.&#xD;
  &#xD;
        2.3 Exclusion Criteria&#xD;
  &#xD;
          -  Invasion anomaly,&#xD;
  &#xD;
          -  Diagnosed with preeclampsia,&#xD;
  &#xD;
          -  Placenta previa cases,&#xD;
  &#xD;
          -  Hypertensive pregnant women receiving antihypertensive therapy,&#xD;
  &#xD;
          -  Diabetic pregnant women,&#xD;
  &#xD;
          -  Multiple pregnancies,&#xD;
  &#xD;
          -  Major hepatic, cardiac, renal, respiratory disorders&#xD;
  &#xD;
          -  Deep vein thrombosis during pregnancy,&#xD;
  &#xD;
          -  Receiving anticoagulant therapy&#xD;
  &#xD;
          -  Patients who developed atony and uterine rupture in the operating room,&#xD;
  &#xD;
          -  Suspected placental invasion&#xD;
  &#xD;
          -  Uterine balloon tamponade&#xD;
  &#xD;
          -  Arterial embolization&#xD;
  &#xD;
          -  Uterine and hypogastric artery ligation,&#xD;
  &#xD;
          -  Uterine compression sutures&#xD;
  &#xD;
          -  Intraoperative blood loss was estimated to be over 1000 mL during CS and who received&#xD;
             intraoperative blood transfusion&#xD;
  &#xD;
        2.4 Patient Selection&#xD;
  &#xD;
        For randomization, patients were fully informed about the study while preparing for CS.&#xD;
        Sandbags were placed in all cases included in the study after meeting the study criteria for&#xD;
        between 1 January 2021 and 30 June 2021. Sandbags were not placed in the cases who met the&#xD;
        study criteria and were included in the study between 1 July 2021 and 31 December 2021.2.5&#xD;
        Sampling Technique&#xD;
  &#xD;
        Qualified participants who gave informed consent to participate in the study were randomly&#xD;
        assigned to groups. Visual analog scale (VAS) was used for postoperative pain scoring at the&#xD;
        8th and 24th postoperative hours. The patient included in the study was randomized into&#xD;
        control group or weighted group by another assistant doctor who did not participate in the CS&#xD;
        and did not know about the patient.&#xD;
  &#xD;
        2.6 Postoperative Monitoring&#xD;
  &#xD;
        All cases were given 10 IU of oxytocin IV during CS, after prophylactic antibiotic therapy&#xD;
        and placenta separation. After CS, 40 IU of oxytocin (Synpitan® forte ampule 5 IU, Deva,&#xD;
        Istanbul, Turkey) was administered intravenously in 500 mL saline and at an infusion rate of&#xD;
        125 mL/hour. At the same time, 0.2-0.4 µg methylergonovine maleate (Methergine® ampule 0.2&#xD;
        µmg, Sandoz, Istanbul, Turkey) was given intravenously/intramuscularly in cases without&#xD;
        hypertension. All patients were treated according to the postoperative protocol for CS&#xD;
        performed in our obstetrics clinic. At the 8th and 24th hours postoperatively, the&#xD;
        researchers determined the patient's hemoglobin (Hb) and hematocrit (Hct) concentrations and&#xD;
        the amount of vaginal bleeding. In addition, the time of milk coming from the breast and VAS&#xD;
        were performed. Patients with a postoperative Hb value of &lt;7 g/dL received blood transfusion.&#xD;
        Considering the risks of blood transfusion, blood transfusion is primarily planned in&#xD;
        symptomatic patients with an Hct value of &lt;20%, as stated in the bulletin of The American&#xD;
        College of Obstetricians and Gynecologists (ACOG), but if the Hb is below 7 g/dL, it is&#xD;
        hemodynamically stable and in asymptomatic patients, the treatment is individualized and&#xD;
        alternative to transfusion, oral anti anemic or intravenous iron therapy is applied.&#xD;
  &#xD;
        2.7 Determination of the Amount of Postoperative Blood Loss&#xD;
  &#xD;
        Postoperative blood loss was determined by monitoring the pad and measuring the hemoglobin&#xD;
        values at the 8th and 24th hours in all cases. Standard pads measuring 10 × 10 cm2 was used.&#xD;
        The main advantage of this method of visually assessing blood loss is that it is a real-time&#xD;
        assessment and allows the person accompanying the delivery to correlate it with the patient's&#xD;
        clinical findings. However, significant differences between clinical evaluation and actual&#xD;
        measurements have been clearly demonstrated in many studies has been reported that&#xD;
        gravimetric blood loss estimation methods or serum lactate measurements can provide a more&#xD;
        objective assessment of bleeding. It has been reported that visual and gravimetric blood loss&#xD;
        estimation measurements show a high degree of bias and therefore their routine use cannot be&#xD;
        recommended. On the other hand, it has been stated that colorimetric technology offers&#xD;
        real-time measurement and has a high degree of correlation. For this reason, we used the&#xD;
        preoperatively and postoperatively at the 8th and 24th hours hemoglobin values. Postpartum&#xD;
        anemia was defined as hemoglobin concentration (Hb) &lt;10 g/dL in the postpartum period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">December 31, 2021</completion_date>
    <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>It is a prospective, randomized, controlled single-center study.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.</measure>
      <time_frame>24 hours</time_frame>
      <description>Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">482</enrollment>
    <condition>Postoperative Bleeding</condition>
    <arm_group>
      <arm_group_label>Sandbag</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Sandbag</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sandbag</intervention_name>
      <description>The standard sandbag used in our clinic, 20 × 20 × 3 cm3 in dimensions and 3 kg in weight</description>
      <arm_group_label>Sandbag</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the&#xD;
          study.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Invasion anomaly,&#xD;
  &#xD;
            -  Diagnosed with preeclampsia,&#xD;
  &#xD;
            -  Placenta previa cases,&#xD;
  &#xD;
            -  Hypertensive pregnant women receiving antihypertensive therapy,&#xD;
  &#xD;
            -  Diabetic pregnant women,&#xD;
  &#xD;
            -  Multiple pregnancies,&#xD;
  &#xD;
            -  Major hepatic, cardiac, renal, respiratory disorders&#xD;
  &#xD;
            -  Deep vein thrombosis during pregnancy,&#xD;
  &#xD;
            -  Receiving anticoagulant therapy&#xD;
  &#xD;
            -  Patients who developed atony and uterine rupture in the operating room,&#xD;
  &#xD;
            -  Suspected placental invasion&#xD;
  &#xD;
            -  Uterine balloon tamponade&#xD;
  &#xD;
            -  Arterial embolization&#xD;
  &#xD;
            -  Uterine and hypogastric artery ligation,&#xD;
  &#xD;
            -  Uterine compression sutures&#xD;
  &#xD;
            -  Intraoperative blood loss was estimated to be over 1000 mL during CS and who received&#xD;
               intraoperative blood transfusion&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Uterine compression methods reduce the amount of postpartum bleeding</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sehmus Pala</last_name>
      <role>Study Chair</role>
      <affiliation>University of Firat</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Firat University Faculty of Medicine</name>
        <address>
          <city>Elazığ</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Firat University</investigator_affiliation>
      <investigator_full_name>Mustafa YILMAZ</investigator_full_name>
      <investigator_title>Firat University</investigator_title>
    </responsible_party>
    <keyword>cesarean section</keyword>
    <keyword>fundal pressure</keyword>
    <keyword>postoperative bleeding</keyword>
    <keyword>sandbag</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhage</mesh_term>
      <mesh_term>Postoperative 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>
  
  
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/NCT06005831
  org study id: 2020/14-02
  nct id: NCT06005831
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Uterine compression methods reduce the amount of postpartum bleeding. In our study, we
        investigated the effect of fundal pressure, which will be created by a sandbag placed on the
        abdomen, on reducing post-cesarean bleeding. Material and Methods: A total of 482 patients
        who delivered by cesarean section (CS) in the Obstetrics Clinic of Fırat University Faculty
        of Medicine between January 2021 and December 2021 were included in this prospective,
        randomized, single-center study.
  A total of 482 patients who gave birth by CS in the Obstetrics Clinic of Fırat University
        Faculty of Medicine between 1 January 2021 and 31 December 2021 were included in the study.
        Approval was obtained from the Ethics Committee of Fırat University for this prospective
        randomized single-center study (Ethics committee date = 15.10.2020; decision no =
        2020/14-02). The 482 patients who had CS were divided into two groups, control group (n =
        246), weighted group (n = 236) was randomized. Each patient was followed up in our obstetrics
        clinic until discharge from the hospital after surgery and the data were analyzed. The same
        techniques were used in all surgical procedures in order not to create differences in terms
        of surgical techniques and operation times that may affect intraoperative bleeding. However,
        to minimize inter-operator variations, surgical procedures were performed by operators with
        sufficient surgical experience.
  
        The standard sandbag used in our clinic was 20 × 20 × 3 cm3 in dimensions and 3 kg in weight.
        Sandbags of the same standard were used for all patients. After the patient was taken to the
        patient's bed, the uterine fundus was palpated, and then the sandbag was placed on the
        abdomen, just above the fundus, in such a way as to apply pressure to the fundus. The sandbag
        was kept on the abdomen for approximately 6 hours. During this period, the patient was
        followed up frequently and care was taken not to change the position of the sandbag. Sandbags
        were removed just before our patients were mobilized (approximately 6 hours). The sandbag was
        placed on the same spot in each patient by the obstetric assistants in our author team. In
        addition, preoperative and postoperative follow-ups and data acquisition and storage were
        performed by the same team 2.1 Study Design
  
        It is a prospective, randomized, controlled single-center study.
  
        2.2 Inclusion Criteria
  
        All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the
        study.
  
        2.3 Exclusion Criteria
  
          -  Invasion anomaly,
  
          -  Diagnosed with preeclampsia,
  
          -  Placenta previa cases,
  
          -  Hypertensive pregnant women receiving antihypertensive therapy,
  
          -  Diabetic pregnant women,
  
          -  Multiple pregnancies,
  
          -  Major hepatic, cardiac, renal, respiratory disorders
  
          -  Deep vein thrombosis during pregnancy,
  
          -  Receiving anticoagulant therapy
  
          -  Patients who developed atony and uterine rupture in the operating room,
  
          -  Suspected placental invasion
  
          -  Uterine balloon tamponade
  
          -  Arterial embolization
  
          -  Uterine and hypogastric artery ligation,
  
          -  Uterine compression sutures
  
          -  Intraoperative blood loss was estimated to be over 1000 mL during CS and who received
             intraoperative blood transfusion
  
        2.4 Patient Selection
  
        For randomization, patients were fully informed about the study while preparing for CS.
        Sandbags were placed in all cases included in the study after meeting the study criteria for
        between 1 January 2021 and 30 June 2021. Sandbags were not placed in the cases who met the
        study criteria and were included in the study between 1 July 2021 and 31 December 2021.2.5
        Sampling Technique
  
        Qualified participants who gave informed consent to participate in the study were randomly
        assigned to groups. Visual analog scale (VAS) was used for postoperative pain scoring at the
        8th and 24th postoperative hours. The patient included in the study was randomized into
        control group or weighted group by another assistant doctor who did not participate in the CS
        and did not know about the patient.
  
        2.6 Postoperative Monitoring
  
        All cases were given 10 IU of oxytocin IV during CS, after prophylactic antibiotic therapy
        and placenta separation. After CS, 40 IU of oxytocin (Synpitan® forte ampule 5 IU, Deva,
        Istanbul, Turkey) was administered intravenously in 500 mL saline and at an infusion rate of
        125 mL/hour. At the same time, 0.2-0.4 µg methylergonovine maleate (Methergine® ampule 0.2
        µmg, Sandoz, Istanbul, Turkey) was given intravenously/intramuscularly in cases without
        hypertension. All patients were treated according to the postoperative protocol for CS
        performed in our obstetrics clinic. At the 8th and 24th hours postoperatively, the
        researchers determined the patient's hemoglobin (Hb) and hematocrit (Hct) concentrations and
        the amount of vaginal bleeding. In addition, the time of milk coming from the breast and VAS
        were performed. Patients with a postoperative Hb value of <7 g/dL received blood transfusion.
        Considering the risks of blood transfusion, blood transfusion is primarily planned in
        symptomatic patients with an Hct value of <20%, as stated in the bulletin of The American
        College of Obstetricians and Gynecologists (ACOG), but if the Hb is below 7 g/dL, it is
        hemodynamically stable and in asymptomatic patients, the treatment is individualized and
        alternative to transfusion, oral anti anemic or intravenous iron therapy is applied.
  
        2.7 Determination of the Amount of Postoperative Blood Loss
  
        Postoperative blood loss was determined by monitoring the pad and measuring the hemoglobin
        values at the 8th and 24th hours in all cases. Standard pads measuring 10 × 10 cm2 was used.
        The main advantage of this method of visually assessing blood loss is that it is a real-time
        assessment and allows the person accompanying the delivery to correlate it with the patient's
        clinical findings. However, significant differences between clinical evaluation and actual
        measurements have been clearly demonstrated in many studies has been reported that
        gravimetric blood loss estimation methods or serum lactate measurements can provide a more
        objective assessment of bleeding. It has been reported that visual and gravimetric blood loss
        estimation measurements show a high degree of bias and therefore their routine use cannot be
        recommended. On the other hand, it has been stated that colorimetric technology offers
        real-time measurement and has a high degree of correlation. For this reason, we used the
        preoperatively and postoperatively at the 8th and 24th hours hemoglobin values. Postpartum
        anemia was defined as hemoglobin concentration (Hb) <10 g/dL in the postpartum period.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: It is a prospective, randomized, controlled single-center study.
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized.
  measure: Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
  time frame: 24 hours
  description: Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
  arm group label: Sandbag
  arm group type: Other
  description: Sandbag
  intervention type: Other
  intervention name: sandbag
  description: The standard sandbag used in our clinic, 20 × 20 × 3 cm3 in dimensions and 3 kg in weight
  arm group label: Sandbag
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Uterine compression methods reduce the amount of postpartum bleeding
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Sehmus Pala
  role: Study Chair
  affiliation: University of Firat
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Firat University
  investigator full name: Mustafa YILMAZ
  investigator title: Firat University
  mesh term: Hemorrhage
  mesh term: Postoperative Hemorrhage
  sharing ipd: No