NCT03820206

Brief Summary

A full medical history will be obtained from all participants. Obstetric ultrasonography and laboratory tests will be performed.According to group assignment, either 1 g(10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision over a 5-minute period. Following delivery, patients in both groups will receive an intravenous bolus of 5 IU oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated Ringer's solution(infused at a rate of 125 mL/h)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 25, 2019

Last Update Submit

January 2, 2020

Conditions

Intraoperative Bleeding

Outcome Measures

Primary Outcomes (1)

  • Estimated blood loss (EBL) during cesarean delivery

    EBL will be calculated according to the formula: EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85)

    during the operation

Study Arms (2)

Tranexamic acid group

ACTIVE COMPARATOR

1 g (10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Drug: Tranexamic AcidProcedure: Cesarean section

Control group

PLACEBO COMPARATOR

30 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Procedure: Cesarean section

Interventions

Tranexamic AcidDRUG

1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.

Also known as: Kapron
Tranexamic acid group
Cesarean sectionPROCEDURE

Lower segement transverse cesarean section

Also known as: Lower segment elective cesarean section
Control groupTranexamic acid group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Grand multipara
  • Multiple pregnancy
  • Polyhydraminos (AFI is more than 24 cm).
  • Placenta previa
  • Gestational diabetes mellitus
  • Preeclampsia
  • Anemia complicating pregnancy (Hemoglobin is less than 11 gm/dl)

You may not qualify if:

  • Allergy to tranxemic acid.
  • H/o suggestive of bleeding disorders
  • previous history of deep vein thrombosis
  • Abnormally invasive placenta
  • Emergency cesarean sections
  • Intraoprative complications during cesarean sections as uterine artery injury and broad ligamentary hematoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

  • Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4.

    PMID: 35287618DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic AcidCesarean Section

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Maged, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

January 31, 2019

Primary Completion

November 15, 2019

Study Completion

January 2, 2020

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

EG(1)