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NCT03856164 · ClinicalTrials.gov registry record · Phase 2
Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery
A Phase 2 study of Blood Loss and Post Partum Hemorrhage, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT03856164 is a Phase 2 study of Blood Loss and Post Partum Hemorrhage that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 110 participants, below the 167-participant average among 8 other Blood Loss trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03856164, a Phase 2 study of Blood Loss and Post Partum Hemorrhage, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid
Study Locations (1)
Texas
- Parkland Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03856164
The ClinicalTrials.gov registry entry for NCT03856164 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 167-participant average among 8 other Blood Loss trials with a reported enrollment target (34% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Blood Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03856164 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03856164 about?
NCT03856164 is a clinical study titled "Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery". 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 pla...
What is the current status of trial NCT03856164?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2019-06-17. Estimated completion is 2020-08-31.
What conditions does trial NCT03856164 study?
This clinical trial studies the following conditions: Blood Loss, Post Partum Hemorrhage, Fibrinolysis; Hemorrhage.
What interventions are being tested in trial NCT03856164?
The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT03856164?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03856164 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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