Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Hemorrhage Clinical Trial

Official title:

Changes in Rate of Hemorrhage With Prophylactic Oxytocin for Second Trimester Dilation and Evacuation in the Clinic Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141447
• Other study ID #: 23-2237
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 20, 2023
• Est. completion date: June 20, 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Megan Masten, MD
• Phone: 303-724-8576
• Email: megan.masten[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 20, 2025
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction and pain scores	Patient satisfaction with procedure and maximum reported pain on a visual analog scale	day of procedure
Other	Ease of procedure	Provider reported ease of procedure	day of procedure
Other	Rate of additional uterotonics	Report of additional medications to treat bleeding used	day of procedure
Other	Cost of additional uterotonics	Estimated cost of additional uterotonics used	day of procedure
Primary	Hemorrhage	Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission	day of procedure
Primary	Quantitative blood loss	Measured blood loss during procedure	day of procedure
Secondary	Procedure time	Length of time of total procedure and length of time until bleeding initially managed	day of procedure