CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 110 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Placebo 100 mLfrom 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/NCT03856164
NCT03856164Phase 3Completed

Use of Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery

University of Texas Southwestern Medical Center·interventional·Posted Feb 27, 2019·Updated Jan 19, 2021

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid and Placebo for Post Partum Hemorrhage and 2 related conditions. Completed, enrolled 110 participants across 1 site.

Detailed Summary

The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans. The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean deliveries with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in women undergoing repeat cesarean sections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 27, 2019
Enrollment StartJun 17, 2019
Primary CompletionJan 10, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.3 years ago

Interventions

Tranexamic Aciddrug

Two doses of Tranexamic Acid (1 gram), diluted in 100 cc of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.

Placebodrug

100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.