Assessing oxytocin's effect on bleeding during second trimester procedures
Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting
This study is testing if giving oxytocin during certain medical procedures can help reduce bleeding for pregnant women who are 18 weeks along or more.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT06141447 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of prophylactic oxytocin in reducing hemorrhage rates during dilation and evacuation (D&E) procedures performed in a clinical setting for patients at 18 weeks gestational age and above. Participants will receive either oxytocin combined with normal saline or normal saline alone. The goal is to determine if the use of oxytocin can lead to better outcomes in terms of bleeding control during these procedures.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing clinic-based D&E at 18 weeks gestational age or above who can communicate in English or Spanish.
Not a fit: Patients with a history of coagulopathy, recent anticoagulant use, or certain pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce hemorrhage rates during second trimester D&E procedures, improving patient safety and outcomes.
How similar studies have performed: While the specific use of prophylactic oxytocin in this context may be novel, similar studies exploring oxytocin's effects in obstetric procedures have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinic-based D\&E at 18 weeks gestational age and above * speaks English or Spanish Exclusion Criteria: * 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
Where this trial is running
Denver, Colorado
- Comprehensive Women's Health Center — Denver, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Megan Masten, MD
- Email: megan.masten@cuanschutz.edu
- Phone: 303-724-8576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.