Abortion, Blood Loss, Dilation and Evacuation, Hemorrhage
Conditions
Brief summary
Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation.
Interventions
DRUGTranexamic acid
1g tranexamic acid mixed in 100mL saline or lactated ringer
DRUGPlacebo
100mL saline or lactated ringers
Sponsors
Society of Family Planning
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Requesting pregnancy termination * Intrauterine pregnancy at 16 to 24 weeks gestation * Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English.
Exclusion criteria
* History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention to control blood loss | At time of procedure | Rate at which providers perform interventions to control blood loss during D&E procedures |
Countries
United States
Outcome results
None listed