Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation

NCT06141447 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-2237
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Hemorrhage

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

  day of procedure

• Quantitative blood loss

  Measured blood loss during procedure

  day of procedure

Secondary Outcomes (1)

• Procedure time

  day of procedure

Other Outcomes (4)

• Patient satisfaction and pain scores

  day of procedure

• Ease of procedure

  day of procedure

• Rate of additional uterotonics

  day of procedure

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin + normal saline

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Oxytocin + normal saline DRUG

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

Oxytocin

Normal saline DRUG

1000 mL bag of normal saline alone

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Oxytocin; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Megan Masten, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This will be a double blinded study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: May 2, 2024
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)