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Recruiting NCT06141447

Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

Phase II Interventional Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxytocin + normal saline, Normal saline.
Who it may be relevant to
Registry conditions: Hemorrhage. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug Oxytocin + normal saline
    40 units IV oxytocin once in a 1000 mL bag of normal saline
  • Drug Normal saline
    1000 mL bag of normal saline alone

Primary outcome measures

  • Hemorrhage [Time frame: day of procedure]
  • Quantitative blood loss [Time frame: day of procedure]
Secondary outcome measures (1)
  • Procedure time [Time frame: day of procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Comprehensive Women's Health Center — Denver

Identifiers

NCT: NCT06141447 · 23-2237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗