Efficacy of Four Different Treatment Regimes on Postpartum Hemorrhage

NCT ID: NCT05467462

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-01-25

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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Carbetocin

100-mg carbetocin was intravenously administered immediately after birth of the baby

Group Type: EXPERIMENTAL

I.V carbetocin administration

Intervention Type: DRUG

Group I: carbetocin was intravenously administered immediately after birth of the baby.

Oxytocin Group

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 Type: EXPERIMENTAL

I.V Oxytocin administration

Intervention Type: DRUG

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.

Carbetocin and Tranexamic acid Group

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 Type: EXPERIMENTAL

I.V carbetocin and tranexamic acid administration

Intervention Type: DRUG

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.

Oxytocin and Tranexamic acid Group

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

Group Type: EXPERIMENTAL

I.V Oxytocin and tranexamic acid administration

Intervention Type: DRUG

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

Interventions

I.V carbetocin administration

Group I: carbetocin was intravenously administered immediately after birth of the baby.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

carbetocin; Oxytocin; carbetocin and tranexamic acid; Oxytocin and tranexamic acid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gurkan Kıran, MD

Role: STUDY_CHAIR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 21047614 (View on PubMed)

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.

Reference Type: RESULT

PMID: 5471863 (View on PubMed)

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.

Reference Type: RESULT

PMID: 1623693 (View on PubMed)

Other Identifiers

04.07.2022-E.69157

Identifier Type: -

Identifier Source: org_study_id