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Clinical Trial NCT06141447 for Hemorrhage is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation Phase 2 150

Recruiting
Clinical Trial NCT06141447 is designed to study Prevention for Hemorrhage. It is a Phase 2 interventional study that is recruiting, having started on May 2, 2024, with plans to enroll 150 participants. Led by University of Colorado, Denver, it is expected to complete by November 2, 2026. The latest data from ClinicalTrials.gov was last updated on December 10, 2024.
Brief Summary
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D&E) in the clinic setting.
Official Title

Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting

Conditions
Hemorrhage
Other Study IDs
  • 23-2237
NCT ID Number
NCT06141447
Start Date (Actual)
2024-05-02
Last Update Posted
2024-12-10
Completion Date (Estimated)
2026-11-02
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalOxytocin
Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.
Oxytocin + normal saline
40 units IV oxytocin once in a 1000 mL bag of normal saline
Placebo ComparatorPlacebo
Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.
Normal saline
1000 mL bag of normal saline alone
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Hemorrhage
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
day of procedure
Quantitative blood loss
Measured blood loss during procedure
day of procedure
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Procedure time
Length of time of total procedure and length of time until bleeding initially managed
day of procedure
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • clinic-based D&E at 18 weeks gestational age and above
  • speaks English or Spanish

  • refuses IV
  • history of coagulopathy
  • anticoagulant use in the preceding five days
  • chorioamnionitis or sepsis
  • suspected placenta accreta spectrum
  • intrauterine fetal demise
  • multiple gestation
  • use of misoprostol for cervical preparation
University of Colorado, Denver logoUniversity of Colorado, Denver480 active studies to explore
Study Central Contact
Contact: Megan Masten, MD, 303-724-8576, [email protected]
1 Study Locations in 1 Countries

Colorado

Comprehensive Women's Health Center, Denver, Colorado, 80230, United States
Megan Masten, MD, Contact
Recruiting