Efficacy of Four Different Treatment Regimes on Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum hemorrhage is the most important cause of maternal morbidity and mortality
      worldwide and accounts for approximately 25% of deaths worldwide. Drugs such as oxytocin,
      carbetocin and tranexamic acid are used for bleeding control after normal vaginal delivery.
      The most widely used agent for the prevention of postpartum hemorrhage worldwide is oxytocin.
      The primary aim of this study is to reduce the mean blood loss after vaginal delivery. In
      this study, investigators aimed to compare the efficacy of carbetocin alone in the 1st group,
      oxytocin alone in the 2nd group, carbetocin and tranexamic acid in the 3rd group, and
      oxytocin and tranexamic acid in the 4th group in preventing postpartum blood loss originating
      from the uterus.
    

Detailed description: 
      This prospective, randomized controlled study was conducted at the Department of Obstetrics
      and Gynecology of Bezmialem University Hospital and Van Regional Training and Research
      Hospital between August 2022 and February 2023. The study protocol was approved by the
      Ethical Committee of the Medical Faculty of Bezmialem University. Written informed consent
      was obtained from all patients. Investigators included a total of 272 women between 18 and 40
      years of age who came to hospital for vaginal delivery at term single pregnancy. This trial
      was designed and reported according to the Consolidated Standards of Reporting Trials
      (CONSORT) guidelines.

      The patients included in this study were randomly divided into four groups by random
      allocation using a computer-generated random number. Group I: carbetocin (Pabal®; Ferring
      Pharma, Istanbul, Turkey) (n = 68 )(was intravenously administered immediately after birth of
      the baby). Group II: Oxytocin(Synpitan forte®; Deva Pharma, Istanbul, Turkey) (n =68)(the
      oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride
      solution and infused at a rate of 125 mL/h was administered immediately after clamping the
      umbilical cord) Group III: carbetocin and tranexamic acid (Transamin; TEVA Pharma, Istanbul,
      Turkey)2 (n =68) (100-mg carbetocin was intravenously administered immediately after birth of
      the baby and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 %
      sodium chloride solution was administered immediately after clamping the umbilical cord) .
      Group IV: oxytocin and tranexamic acid (n=68) (the oxytocin infusion consisting of 20 IU
      dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125
      mL/h was administered and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of
      normal 0.9 % sodium chloride solution was administered immediately after clamping the
      umbilical cord).The collected data were age, prepregnancy body mass index (BMI), gravida,
      parity, gestational age at birth, Apgar scores at 1 and 5 min, birth weight, neonatal
      intensive care unit (NICU) admission, the prepartum hemoglobin and hematocrit concentrations,
      the change in the hemoglobin and hematocrit concentrations (difference between prepartum and
      postpartum levels), duration of delivery stages, intrapartum blood loss and estimated blood
      loss after 2 hours of vaginal delivery.

      In this study, the investigators aimed to compare the efficacy of oxytocin, carbetocin and
      tranexamic acid in preventing uterine blood loss during vaginal delivery.
    

Intervention name(s): I.V carbetocin administration; I.V Oxytocin administration; I.V carbetocin and tranexamic acid administration; I.V Oxytocin and tranexamic acid administration
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Group I: carbetocin was intravenously administered immediately after birth of the baby.; Group II: Oxytocin the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord.; Group III: carbetocin and tranexamic acid 100-mg carbetocin was intravenously administered immediately after birth of the baby and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord.; Group IV: oxytocin and tranexamic acid the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered and tranexamic acid infusion consisting of 1gr dissolved in 100 mL of normal 0.9 % sodium chloride solution was administered immediately after clamping the umbilical cord
Other intervention name(s): carbetocin; Oxytocin; carbetocin and tranexamic acid; Oxytocin and tranexamic acid
Intervention MeSH terms: Tranexamic Acid; Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: postpartum hemorrhage; oxytocin; carbetocin; tranexamic acid