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Hormone Therapy

Oxytocin for Reducing Bleeding

Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinic-based D&E at 18 weeks gestational age and above
Be between 18 and 65 years old
Must not have
Refuses IV
Chorioamnionitis or sepsis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of procedure

Summary

This trial aims to find out if giving oxytocin before a second trimester dilation and evacuation procedure can help reduce the risk of bleeding in a clinic setting.

Who is the study for?
This trial is for individuals undergoing a clinic-based dilation and evacuation (D&E) procedure at or beyond 18 weeks of pregnancy. Participants must be able to communicate in either English or Spanish.
What is being tested?
The study is testing whether giving oxytocin mixed with normal saline before the D&E can reduce bleeding compared to just normal saline. It's designed to see if this approach is effective in preventing hemorrhage during the second trimester D&E procedures.
What are the potential side effects?
Oxytocin may cause side effects such as nausea, vomiting, and abdominal pain. There might also be an increased risk of uterine cramping or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 weeks pregnant and can visit a clinic for check-ups.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I refuse to receive treatments through an IV.
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I have had chorioamnionitis or sepsis.
Select...
I have a history of blood clotting disorders.
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I have used misoprostol for cervical preparation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemorrhage
Quantitative blood loss
Secondary study objectives
Procedure time
Other study objectives
Cost of additional uterotonics
Ease of procedure
Patient satisfaction and pain scores
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,950 Total Patients Enrolled
~100 spots leftby Nov 2026
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