Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Phase 2RecruitingNCT06141447

University of Colorado, Denver150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

150

Conditions

Hemorrhage

Interventions

Oxytocin + normal salineDRUG

40 units IV oxytocin once in a 1000 mL bag of normal saline

Normal salineDRUG

1000 mL bag of normal saline alone

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Comprehensive Women's Health Center

Denver, Colorado, United States

RECRUITING

Outcomes

Primary Outcomes

Hemorrhage

Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission

Time frame: day of procedure

Quantitative blood loss

Measured blood loss during procedure

Time frame: day of procedure

Secondary Outcomes

Procedure time

Length of time of total procedure and length of time until bleeding initially managed

Time frame: day of procedure

Central Contacts

Megan Masten, MD

CONTACT

303-724-8576 megan.masten@cuanschutz.edu

Data from ClinicalTrials.gov

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