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Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 10 mL of normal saline administered via IV at the start of the D&E procedure |
|
| Tranexamic acid | Active Comparator | 1g tranexamic acid administered via IV at the start of the D&E procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1g tranexamic acid |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of excessive bleeding | The use of any of the following interventions to manage excessive bleeding: at least one uterotonic medication given (i.e. methylergonovine maleate, carboprost tromethamine, misoprostol or additional oxytocin after the standard 30 units), blood transfusion, re-aspiration for bleeding or hematometra, intra-uterine balloon tamponade, uterine artery embolization, major surgery for bleeding, admission for bleeding, or prescription given for any uterotonic medication at discharge. | During the D&E procedure or immediately after |
| Measure | Description | Time Frame |
|---|---|---|
| Mean intra-operative quantitative blood loss | Blood loss measured from the start of the procedure (after removal of cervical dilators) until the end of the procedure (after removal of the speculum). Blood loss will be measured in mL by collecting the blood in a draped bag underneath the patient and weighing all gauze/chux used during the procedure. | During the D&E procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Greiner, MD, MPH | Contact | 858-329-4464 | familyplanningresearch@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | San Diego | California | 92037 | United States |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
10 mL 0.9% normal saline |
|
| Mean post-operative quantitative blood loss | Any bleeding that occurs after speculum removal in the procedural room until the patient leaves clinic on the day of the procedure up to 4 hours following the procedure. The patient's menstrual pad(s) in the recovery room will be weighed. | on the day of the procedure up to 4 hours following the procedure |
| Total number of interventions to control bleeding | The total number of interventions performed within the primary composite outcome will be assessed. | During the D&E procedure or immediately after |
| Individual interventions used to control bleeding for each participant | Individual outcomes within the primary composite outcome will be assessed. | During the D&E procedure or immediately after |
| Number of doses of uterotonics given | We will assess the number of doses of uterotonics given for each participant | During the D&E procedure or immediately after |
| Provider satisfaction with bleeding outcomes | Each D&E provider will be asked about their satisfaction with bleeding outcomes for the procedure using a 5 point Likert scale (from 0 being very unsatisfied to 5 being very satisfied). | Immediately after the D&E procedure |
| Provider assessment of which treatment assignment they believe the participant received | D&E providers will be asked if they think the participant received the study drug or placebo. | Immediately after the D&E procedure |
| Length of the procedure | The length of the D&E procedure will be recorded in minutes from the time the speculum is first instrument is placed in the uterus until the speculum is removed (minus any time for IUD placement). | During the D&E procedure |
| Adverse events | Adverse events will be assessed including: thromboembolic event, nausea, vomiting, dizziness or hypersensitivity will be ascertained on day of the procedure and by patient self report after | During the D&E procedure or immediately after |
| Planned Parenthood of the Pacific Southwest | Recruiting | San Diego | California | 92101 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|