Abortion, Blood Loss, Dilation and Evacuation, Hemorrhage, Prophylactic Tranexamic Acid Use
Conditions
Keywords
abortion, dilation and evacuation, TXA, hemorrhage, Tranexamic acid, D&E
Brief summary
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.
Interventions
DRUGTranexamic Acid
1g tranexamic acid
DRUGPlacebo
10 mL 0.9% normal saline
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to understand and sign informed consent * Speaks English or Spanish language, * Requesting pregnancy termination or procedural management of fetal demise - Intrauterine pregnancy, 18 weeks 0 days and 24 weeks and 0 days gestation
Exclusion criteria
* History of or current thromboembolic event (deep vein thrombosis, stroke, pulmonary embolism) * History of coagulopathy * Anticoagulant use in the preceding five days * Severe renal impairment * Chorioamnionitis or sepsis * Suspected placenta accreta spectrum * Prophylactic uterotonics other than oxytocin given (or planned to be given) at the start of the D\&E * Known allergic reaction or hypersensitivity to TXA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of excessive bleeding | During the D&E procedure or immediately after | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean intra-operative quantitative blood loss | During the D&E procedure | 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. |
| Mean post-operative quantitative blood loss | on the day of the procedure up to 4 hours following the procedure | 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. |
| Total number of interventions to control bleeding | During the D&E procedure or immediately after | The total number of interventions performed within the primary composite outcome will be assessed. |
| Individual interventions used to control bleeding for each participant | During the D&E procedure or immediately after | Individual outcomes within the primary composite outcome will be assessed. |
| Number of doses of uterotonics given | During the D&E procedure or immediately after | We will assess the number of doses of uterotonics given for each participant |
| Provider satisfaction with bleeding outcomes | Immediately after the D&E procedure | 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). |
| Provider assessment of which treatment assignment they believe the participant received | Immediately after the D&E procedure | D\&E providers will be asked if they think the participant received the study drug or placebo. |
| Length of the procedure | During the D&E 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). |
| Adverse events | During the D&E procedure or immediately after | 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 |
Countries
United States
Contacts
CONTACTKaren Greiner, MD, MPH
Outcome results
None listed