NCT05273632

Brief Summary

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

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 Mar 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

December 2, 2020

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

March 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

December 2, 2020

Last Update Submit

February 5, 2023

Conditions

Blood Loss, SurgicalBlood Loss, Postoperative

Keywords

blood losscesarean sectionoxytocintranexamic acidetamsylatesalineIntra-operativePostoperative

Outcome Measures

Primary Outcomes (1)

  • blood loss during and after cesarean delivery

    Measuring of Hemoglobin level and Hematocrit level pre and post operatively.

    First 2 hours after C-Section

Secondary Outcomes (1)

  • post operative bleeding

    first 24 hours after C-Section

Study Arms (3)

Oxytocin

ACTIVE COMPARATOR

Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision

Drug: Oxytocin

Tranexamic acid and Etamsylate

ACTIVE COMPARATOR

Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery

Drug: Oxytocin

Saline

PLACEBO COMPARATOR

Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section

Drug: Oxytocin

Interventions

OxytocinDRUG

trial of reduction of losing blood intra operative or post operative during Cesarean Delivery

Also known as: Tranexamic acid and Etamsylate
OxytocinSalineTranexamic acid and Etamsylate

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant females admitted for Elective Cesarean Section.
  • Gestational age of pregnancy (38 weeks To 40 weeks).
  • the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
  • Singleton living fetus.
  • No medical disorders.
  • Informed Oral Consent From The Patient.

You may not qualify if:

  • Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).
  • Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
  • Acute liver or kidney diseases; blood disorders, such as anaemia.
  • Allergy to Tranexamic acid.
  • Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
  • Ante partum Hemorrhage such placental abruption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Blood Loss, SurgicalPostoperative HemorrhageHemorrhage

Interventions

OxytocinTranexamic AcidEthamsylate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsPostoperative Complications

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

March 10, 2022

Study Start

March 20, 2022

Primary Completion

September 15, 2022

Study Completion

September 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)