High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth

NCT06550089 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IRB24-0398
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.

Conditions

Postpartum Hemorrhage; Pregnancy Complications; Cesarean Section Complications

Keywords

oxytocin; cesarean delivery; postpartum hemorrhage

Outcome Measures

Primary Outcomes (4)

• Screen failure rate

  Number of individuals who are eligible for the study but do not consent to participate

  Within 8 hours prior to cesarean delivery

• Fidelity rate

  Frequency of fidelity to the trial

  Within 8 hours prior to cesarean delivery

• Trial retention rate

  Frequency of participant completion of all study visits

  Up to 6 weeks after cesarean delivery

• Acceptability of the intervention

  Frequency of acceptability of the intervention by both participants and their providers

  Up to 6 weeks after cesarean delivery

Secondary Outcomes (14)

• Maternal flushing

  During and up to 6 hours after cesarean delivery

• Maternal hypotension

  During and up to 6 hours after cesarean delivery

• Maternal nausea/vomiting

  During and up to 6 hours after cesarean delivery

• Myocardial ischemia

  During and up to 24 hours after cesarean delivery

• Cardiac arrhythmia

  During and up to 24 hours after cesarean delivery

Study Arms (2)

High-dose oxytocin

EXPERIMENTAL

900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

Drug: Oxytocin

Low-dose oxytocin

ACTIVE COMPARATOR

For unlabored cesarean births: 300 mL/hr (18 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery For laboring cesarean births: 600 mL/hr (36 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.

High-dose oxytocin; Low-dose oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater
• English or Spanish speaking
• Individuals undergoing a scheduled or unscheduled cesarean delivery

You may not qualify if:

• Patient on therapeutic anticoagulation
• Patient with hypertensive disorder of pregnancy or chronic hypertension
• Patient with preexisting bleeding disorder
• Patient with preexisting cardiac disease
• Patient with severe asthma, defined as the need for two or more agents for disease control, or bronchospasm
• Patient undergoing planned cesarean hysterectomy

Sponsors & Collaborators

• University of Chicago: lead
• Medical College of Wisconsin: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage; Pregnancy Complications

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; 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

Study Officials

• Ashish Premkumar, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Anna Palatnik, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE