Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Phase 4RecruitingNCT06820177

University of California, San Diego276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

276

Conditions

Abortion Dilation and Evacuation Hemorrhage

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of California San Diego

San Diego, California, United States

RECRUITING

Planned Parenthood of the Pacific Southwest

San Diego, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: During the D&E procedure or immediately after

Secondary Outcomes

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.

Time frame: During the D&E procedure

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: During the D&E procedure or immediately after

Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts