Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage
• Intervention / Treatment: Drug: Oxytocin + normal saline; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Megan Masten, MD; Phone Number: 303-724-8576; Email: megan.masten@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Recruiting
      • Comprehensive Women's Health Center
      • Contact: Megan Masten, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; 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; 40 units IV oxytocin once in a 1000 mL bag of normal saline
Placebo Comparator: Placebo; Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D&E.	Drug: Normal saline; 1000 mL bag of normal saline alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quantitative blood loss	Measured blood loss during procedure	day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	Length of time of total procedure and length of time until bleeding initially managed	day of procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction and pain scores	Patient satisfaction with procedure and maximum reported pain on a visual analog scale	day of procedure
Ease of procedure	Provider reported ease of procedure	day of procedure
Rate of additional uterotonics	Report of additional medications to treat bleeding used	day of procedure
Cost of additional uterotonics	Estimated cost of additional uterotonics used	day of procedure

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 2, 2026

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 23-2237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No