Uterine Fundus Pressure in Reduction of Cesarean Bleeding
Condition: Postoperative Bleeding
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): sandbag
Intervention type(s): Other
Intervention description(s): The standard sandbag used in our clinic, 20 × 20 × 3 cm3 in dimensions and 3 kg in weight
Intervention model: Single Group Assignment
Intervention model description: It is a prospective, randomized, controlled single-center study.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cesarean section; fundal pressure; postoperative bleeding; sandbag