A Phase 2 interventional study of Oxytocin + normal saline and Normal saline in Hemorrhage, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Prevention
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.
3,011 studies on the registry are indexed under Hemorrhage; 466 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 1,990 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.
Drug: Oxytocin + normal saline
Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.
Drug: Normal saline
40 units IV oxytocin once in a 1000 mL bag of normal saline
1000 mL bag of normal saline alone
Hemorrhage
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Time frame: day of procedure
Quantitative blood loss
Measured blood loss during procedure
Time frame: day of procedure
Procedure time
Length of time of total procedure and length of time until bleeding initially managed
Time frame: day of procedure
Patient satisfaction and pain scores
Patient satisfaction with procedure and maximum reported pain on a visual analog scale
Time frame: day of procedure
Ease of procedure
Provider reported ease of procedure
Time frame: day of procedure
Rate of additional uterotonics
Report of additional medications to treat bleeding used
Time frame: day of procedure
Cost of additional uterotonics
Estimated cost of additional uterotonics used
Time frame: day of procedure
Plan to share: No
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