Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation
NCT ID: NCT06141447
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-05-02
2026-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Oxytocin
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
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
Interventions
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Oxytocin + normal saline
40 units IV oxytocin once in a 1000 mL bag of normal saline
Normal saline
1000 mL bag of normal saline alone
Eligibility Criteria
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Inclusion Criteria
* speaks English or Spanish
Exclusion Criteria
* 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
18 Years
55 Years
FEMALE
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Locations
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Comprehensive Women's Health Center
Denver, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Megan Masten, MD
Role: primary
Other Identifiers
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23-2237
Identifier Type: -
Identifier Source: org_study_id