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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 Postpartum Hemorrhage and Blood Loss, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT03856164: Completed Phase 2 study of Postpartum Hemorrhage and Blood Loss, sponsored by University of Texas Southwestern Medical Center.
NCT03856164 is a Phase 2 study of Postpartum Hemorrhage and Blood Loss that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 110 participants, below the 774-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03856164, a Phase 2 study of Postpartum Hemorrhage and Blood Loss, 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.
Primary Outcome
Total blood volume loss will be calculated in milliliters.
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 |
What the finished NCT03856164 record still lists
NCT03856164 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 774-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Postpartum Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03856164 reports a single indexed study location in 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: Postpartum Hemorrhage, Blood Loss, 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.
Learn More About Clinical Trials
Similar trials for Postpartum Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03856164's enrollment target sits among peer trials
110 9th of 19 higher than 11 of 19 other Postpartum Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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