Randomization of Oxytocin, Oxytocin+Intrauterine Misoprostol and Carbetocin During C-section
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Postpartum haemorrhage (PPH) remains an important cause of maternal morbidity and mortality
      and it accounts for approximately 25% of all deaths worldwide. Drugs such as oxytocin,
      carbetocin, misoprostol, prostaglandin F2a and methylergonovine have been tested for bleeding
      control during and after cesarean section. Oxytocin is the most widely used agent for the
      prevention of postpartum hemorrhage.The primary aim of this study is to reduce the mean blood
      loss during cesarean section.In this study, the investigators planned to compare peroperative
      and postoperative blood loss levels by giving oxytocin alone to the 1st group, oxytocin and
      intrauterine misoprostol to the 2nd group, and carbetocin to the 3rd group of patients who
      were randomly divided into 3 groups.In this study, we aimed to compare the efficacy of
      oxytocin, misoprostol and carbetocin in preventing uterine blood loss during cesarean
      section.
    

Detailed description: 
      Our prospective, randomized controlled study was conducted at the Department of Obstetrics
      and Gynecology of Bezmialem University Hospital between July and November 2021. The study
      protocol was approved by the Ethical Committee of the Medical Faculty of Bezmialem
      University. Written informed consent was obtained from all patients. We included a total of
      156 women between 18 and 40 years of age who underwent a primary cesarean section or old 1
      cesarean section under spinal anesthesia at term single pregnancy with an American Society of
      Anesthesiology physical status of I or II. 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 three groups by random
      allocation using a computer-generated random number. Group I: Oxytocin(Synpitan forte®; Deva
      Pharma, Istanbul, Turkey) (n = 52 )( 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 II: (n =52) oxytocin plus
      intrauterine misoprostol (Synpitan forte®; Deva Pharma, Istanbul, Turkey) (the oxytocin
      infusion was administered immediately after clamping the umbilical cord and misoprostol
      tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta
      and swabbing the cavity. Group III: (n =52) 100-mg carbetocin (Synpitan forte®; Deva Pharma,
      Istanbul, Turkey) was intravenously administered immediately after birth of the baby. All
      surgeries were performed by the same team of two surgeons.. The collected data were age,
      prepregnancy body mass index (BMI), gravida, parity, indication of cesarean section,
      gestational age at birth, Apgar scores at 1 and 5 min, birth weight, neonatal intensive care
      unit (NICU) admission, the preoperative hemoglobin and hematocrit concentrations, the change
      in the hemoglobin and hematocrit concentrations (difference between preoperative and
      postoperative levels), operating time, intraoperative blood loss.

      In this study, the investigators aimed to compare the efficacy of oxytocin, misoprostol and
      carbetocin in preventing uterine blood loss during cesarean section.
    

Intervention name(s): I.V Oxytocin administration
Intervention type(s): Drug
Intervention description(s): Group I: 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 II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
Other intervention name(s): I.v Oxytocin+intrauterine misoprostol; I.V carbetocin administration
Intervention MeSH terms: Misoprostol; Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: postpartum hemorrhage; oxytocin; misoprostol; carbetocin