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Hormone Therapy

Deuterated Oxytocin for Postpartum Hemorrhage

Phase 2

Waitlist Available

Led By Naida M Cole, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperatively (60 minutes following clamping of the umbilical cord)

Awards & highlights

Study Summary

This trial will help researchers understand why oxytocin, the first-line drug to prevent uterine atony, sometimes fails. Participants will receive a single dose of deuterium-labeled oxytocin, followed by an infusion of unlabeled oxytocin. Blood samples will be taken to measure plasma concentrations of both oxytocins over time.

Who is the study for?

This trial is for pregnant women aged 18-50, at term (37+ weeks), undergoing a scheduled or unscheduled but non-emergent cesarean delivery. It's not suitable for those with an emergency c-section or allergy to oxytocin, or who cannot consent.Check my eligibility

What is being tested?

The study tests deuterated oxytocin (d5OT) to understand its pharmacokinetics and pharmacodynamics in preventing uterine atony after childbirth. Participants will receive d5OT intravenously post-delivery, followed by regular oxytocin, while their uterine contractions are monitored.See study design

What are the potential side effects?

While the side effects aren't detailed here, typical reactions to oxytocin may include nausea, vomiting, and rapid heartbeat. The study aims to monitor how the uterus responds rather than focusing on adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperatively (60 minutes following clamping of the umbilical cord)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperatively (60 minutes following clamping of the umbilical cord)

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperatively (60 minutes following clamping of the umbilical cord) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

0-10 Uterine Tone Score

Baseline plasma concentrations of deuterated oxytocin

Plasma concentrations of deuterated oxytocin at 1 minute

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oxytocin PK/PD ArmExperimental Treatment1 Intervention

Eligible subjects will receive a single, 1 IU bolus of deuterated oxytocin (d5OT) intra-operatively, followed by an infusion of standard therapeutic d0 oxytocin immediately after umbilical cord clamping.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

817,750 Total Patients Enrolled

Lucile Packard Children's HospitalOTHER

15 Previous Clinical Trials

2,671 Total Patients Enrolled

Naida M Cole, MDPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Postpartum Hemorrhage

100 Patients Enrolled for Postpartum Hemorrhage

Media Library

Deuterated Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05488457 — Phase 2

Postpartum Hemorrhage Research Study Groups: Oxytocin PK/PD Arm

Postpartum Hemorrhage Clinical Trial 2023: Deuterated Oxytocin Highlights & Side Effects. Trial Name: NCT05488457 — Phase 2

Deuterated Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488457 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to join this investigation?

"Based on information from clinicaltrials.gov, this medical trial is not currently recruiting patients due to its last update on August 4th 2022; however, there are 386 other trials that require participants at the moment. The study was initially posted back in January 2nd 2023."

Answered by AI

Is this remedy a reliable and secure solution for patients?

"This therapy has been evaluated for safety and earned a 2, since it is currently in Phase 2. To date no evidence of efficacy exists but there has been some data gathered on the medication's security."

Answered by AI