CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Tranexamic Acid 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02780245
NCT02780245Phase 4Completed
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Tranexamic Acid Versus Novel Uterine Cooling Technique in Reducing Blood Loss and Incidence of Postpartum Hemorrhage at Caesarean Section

Talkha Central Hospital·interventional·Posted May 23, 2016·Updated Sep 5, 2016

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid and Intraoperative Uterine Cooling for Hemorrhage of Cesarean Section and/or Perineal Wound and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage of Cesarean Section and/or Perineal Wound, Postpartum Hemorrhage, Uterine Atony
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 23, 2016
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago

Interventions

Tranexamic Aciddrug

At 20 minutes preoperatively, TXA of 20 mg/kg was administered in Z Solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g).

Intraoperative Uterine Coolingprocedure

Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.