Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Phase 2

Recruiting

• Conditions: Hemorrhage
• Interventions: Drug: Oxytocin + normal saline; Drug: Normal saline

• Registration Number: NCT06141447
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Study Start: 2024-05-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-11-02
• Study Completion: 2026-11-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• clinic-based D&E at 18 weeks gestational age and above
• speaks English or Spanish

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin + normal saline	Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.
Placebo	Normal saline	Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.

Primary Outcome Measures

Name	Time	Method
Hemorrhage	day of procedure	Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Quantitative blood loss	day of procedure	Measured blood loss during procedure

Secondary Outcome Measures

Name	Time	Method
Procedure time	day of procedure	Length of time of total procedure and length of time until bleeding initially managed

Trial Locations

Locations (1)

Comprehensive Women's Health Center; 🇺🇸 Denver, Colorado, United States