Carbetocin Versus Buccal Misoprostol Plus IV Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section
Condition: Cesarean Section Complications
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will
      remain beyond our reach unless we prioritize the prevention and treatment of postpartum
      hemorrhage(PPH) in low-resource countries. Consequently, the administration of uterotonic
      drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has
      become essential to diminish the risk of PPH and improve maternal safety.

      Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10
      min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous
      infusion to attain sustained uterotonic activity throughout the surgical procedure and
      immediate postpartum period.

      Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be
      effective in preventing PPH because of its strong uterotonic effects. In addition,
      misoprostol is inexpensive, stable at room temperature, and easy to administer.

      Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal
      delivery; however, its use in conjunction with CS has not been investigated as much.

      The buccal route is recognized as having the greatest benefit due to its rapid uptake,
      long-acting effect, and greatest bioavailability compared with other routes of misoprostol
      administration.

      Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a
      single-dose injection; intravenously administered carbetocin has a half-life of approximately
      40 min.

      A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min
      and persists for an average of 60 min following injection.

      The aim of this study was to compare the effectiveness of combined buccal misoprostol and IV
      tranexamic acid (TA)with intravenous carbetocin for prevention of PPH in patients with risk
      factors during cesarean section.
    

Detailed description: 
      Eligible and consenting participants were randomized via a computer-generated random number
      sequence into one of two groups: one group received a pre-prepared sealed and opaque packet
      containing 400 μg of misoprostol (2 tablets of 200 μg), 2 ampoules of TA. The other group
      received similar packets containing two placebo tablets, two placebo ampoules (distilled
      water) and separate carbetocin ampoule (100 μg) for slow intravenous injection. The
      misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of TA
      and carbetocin will be also similar to placebo. Randomization was done by the resident
      doctors immediately before transfer to the theater, whereas preparation of packets and
      confidential record maintenance was done by the labor room nursing staff.

      Study drug administration Group 1 100 μg carbetocin ampoule will be diluted in 10 mL normal
      saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the
      birth of the baby

      Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia
      and few minutes before skin incision in addition to 1 gm tranexamic acid in 100 mL of
      intravenous solution infusion over 15 min.

      .
    

Intervention name(s): carbetocin; Tranexamic Acid; misoprostol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby; 1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.; Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision
Other intervention name(s): Active Comparator; Experimental; expremental
Intervention MeSH terms: Misoprostol; Tranexamic Acid; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study drug administration Group 1 100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision in addition to 1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: cesarean section; tranexamic acid; postpartum hemorrhage; buccal misoprostol; carbetocin