NCT05467462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

July 18, 2022

Last Update Submit

January 24, 2023

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhageoxytocincarbetocintranexamic acid

Outcome Measures

Primary Outcomes (1)

  • Hemogram status

    Postpartum hemogram status

    Postpartum 24th hour

Secondary Outcomes (1)

  • Blood Transfusion

    Postpartum 24th hour

Study Arms (4)

Carbetocin

EXPERIMENTAL

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

Drug: I.V carbetocin administration

Oxytocin Group

EXPERIMENTAL

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 Oxytocin administration

Carbetocin and Tranexamic acid Group

EXPERIMENTAL

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 carbetocin and tranexamic acid administration

Oxytocin and Tranexamic acid Group

EXPERIMENTAL

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

Drug: I.V Oxytocin and tranexamic acid administration

Interventions

I.V carbetocin administrationDRUG

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

Also known as: carbetocin
Carbetocin
I.V Oxytocin administrationDRUG

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.

Also known as: Oxytocin
Oxytocin Group
I.V carbetocin and tranexamic acid administrationDRUG

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.

Also known as: carbetocin and tranexamic acid
Carbetocin and Tranexamic acid Group
I.V Oxytocin and tranexamic acid administrationDRUG

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

Also known as: Oxytocin and tranexamic acid
Oxytocin and Tranexamic acid Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 21047614RESULT

  • 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.

    PMID: 5471863RESULT

  • 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.

    PMID: 1623693RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocinOxytocinTranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Gurkan Kıran, MD

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 20, 2022

Study Start

August 1, 2022

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)