Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06141447
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Oxytocin + normal saline — DRUG
    40 units IV oxytocin once in a 1000 mL bag of normal saline
  • Normal saline — DRUG
    1000 mL bag of normal saline alone

Study Details

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.

Key Dates

Start date
May 2, 2024
Status verified
Dec 2024
Primary completion
Nov 2, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Oxytocin
    Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.
  • Placebo Comparator: Placebo
    Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.

Primary Outcome Measure

Hemorrhage [ Time Frame: day of procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Women's Health CenterDenverColorado80230
Megan Masten, MD

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By research site
Comprehensive Women's Health Center· Denver, CO

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