NCT05467462

Efficacy of Four Different Treatment Regimes on Postpartum Hemorrhage

The Efficacy of Four Different Treatment Regimes of Uterotonic Agents for Prevention of Postpartum Hemorrhage at Vaginal Delivery: A Multicentric Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	I.V carbetocin administration	Group I: carbetocin was intravenously administered immediately after birth of the baby.
DRUG	I.V Oxytocin administration	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.
DRUG	I.V carbetocin and tranexamic acid administration	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.
DRUG	I.V Oxytocin and tranexamic acid administration	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

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2022-07-20
• Last updated: 2023-01-26

Locations

1 site across 1 country: Turkey (Türkiye)