Actively Recruiting
Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting
Led by University of Colorado, Denver · Updated on 2024-12-10
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of prophylactic oxytocin on bleeding rates during second trimester dilation and evacuation (D&E) procedures performed in the clinic. This Phase 2 randomized study aims to compare hemorrhage rates and blood loss between groups receiving oxytocin versus placebo, helping to determine if oxytocin can reduce bleeding complications during these procedures. Participants are randomly assigned to receive either 40 units of intravenous oxytocin mixed in 1000 mL of normal saline or 1000 mL of normal saline alone at the time of tenaculum placement for the D&E procedure. The study is triple-blinded and compares these two interventions during the operation. During the procedure day, researchers measure hemorrhage and quantitative blood loss as primary outcomes. Secondary outcomes include procedure time. Participants are monitored throughout the clinic visit, and data on bleeding and procedure duration are collected. The total participation period covers the day of the procedure, with safety and bleeding outcomes evaluated immediately during and after the D&E.
CONDITIONS
Brief Title
Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinic-based dilation and evacuation at 18 weeks gestational age and above
- Speaks English or Spanish
You will not qualify if you...
- Refuses intravenous access
- History of blood clotting disorder (coagulopathy)
- Use of anticoagulant medication in the past five days
- Presence of chorioamnionitis or sepsis
- Suspected placenta accreta spectrum
- Intrauterine fetal demise
- Multiple pregnancy (more than one fetus)
- Use of misoprostol for cervical preparation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants receive either 40 units of IV oxytocin or normal saline alone at the time of tenaculum placement for dilation and evacuation (D&E).
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Comprehensive Women's Health Center
Denver, Colorado, United States, 80230
Actively Recruiting
Research Team
M
Megan Masten, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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