Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 2

Conditions: Hemorrhage

Treatments: Drug: Normal saline; Drug: Oxytocin + normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06141447

23-2237

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.

Treatment:

Drug: Oxytocin + normal saline

Placebo

Placebo Comparator group

Description:

Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.

Treatment:

Drug: Normal saline