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NCT Number: NCT06141447

Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

Location status: Recruiting

Location contact

Megan Masten, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin + normal saline

Drug

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

normal saline

Drug

1000 mL bag of normal saline alone

Primary outcomes

  1. Hemorrhage

    Time frame: 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

  2. Quantitative blood loss

    Time frame: day of procedure

    Measured blood loss during procedure

Secondary outcomes

  1. Procedure time

    Time frame: day of procedure

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

Other outcomes

  1. Patient satisfaction and pain scores

    Time frame: day of procedure

    Patient satisfaction with procedure and maximum reported pain on a visual analog scale

  2. Ease of procedure

    Time frame: day of procedure

    Provider reported ease of procedure

  3. Rate of additional uterotonics

    Time frame: day of procedure

    Report of additional medications to treat bleeding used

  4. Cost of additional uterotonics

    Time frame: day of procedure

    Estimated cost of additional uterotonics used

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Masten, MD

CONTACT

[email protected]

303-724-8576

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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