Clinical trial NCT05467462: Efficacy of Four Different Treatment Regimes on Postpartum Hemorrhage
Official title: The Efficacy of Four Different Treatment Regimes of Uterotonic Agents for Prevention of Postpartum Hemorrhage at Vaginal Delivery: A Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
oxytocin
carbetocin
tranexamic acid
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria

* Single pregnancy greater than 37 weeks
* Pregnant women between the ages of 18-40
* Volunteer

Exclusion Criteria:

* Pregnancy less than 37 weeks
* Patients under stress who cannot give informed consent
* Patients allergic to carbetocin, oxytocin or tranexamic acid
* Clinical diagnosis of a serious cardiovascular disease
* Clinical diagnosis of severe liver disease
* Clinical diagnosis of kidney disease
* Clinical diagnosis of epilepsy
* Internal feature with risk for embolism or bleeding
* Refusing to volunteer

Primary outcomes:
measure: Hemogram status
timeFrame: Postpartum 24th hour
Secondary outcomes:
measure: Blood Transfusion
timeFrame: Postpartum 24th hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Gurkan Kıran, MD
role: STUDY_CHAIR
References:
citation: Grotegut CA, Paglia MJ, Johnson LN, Thames B, James AH. Oxytocin exposure during labor among women with postpartum hemorrhage secondary to uterine atony. Am J Obstet Gynecol. 2011 Jan;204(1):56.e1-6. doi: 10.1016/j.ajog.2010.08.023. Epub 2010 Nov 3.
citation: Chard T, Boyd NR, Forsling ML, McNeilly AS, Landon J. The development of a radioimmunoassay for oxytocin: the extraction of oxytocin from plasma, and its measurement during parturition in human and goat blood. J Endocrinol. 1970 Oct;48(2):223-34. doi: 10.1677/joe.0.0480223. No abstract available.
citation: Hunter DJ, Schulz P, Wassenaar W. Effect of carbetocin, a long-acting oxytocin analog on the postpartum uterus. Clin Pharmacol Ther. 1992 Jul;52(1):60-7. doi: 10.1038/clpt.1992.103.