100 Participants Needed

Deuterated Oxytocin for Postpartum Hemorrhage

Recruiting at 1 trial location
EF
NM
SM
Overseen BySomayeh Mohammadi
Age: 18 - 65
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Deuterated Oxytocin for postpartum hemorrhage?

Research shows that oxytocin, a component of Deuterated Oxytocin, is effective in preventing postpartum hemorrhage, which is a major cause of maternal death. Studies have demonstrated that oxytocin is commonly used and recommended for managing this condition, indicating its effectiveness in reducing bleeding after childbirth.12345

Is deuterated oxytocin safe for humans?

Oxytocin, which is similar to deuterated oxytocin, is generally used to prevent postpartum hemorrhage but can cause side effects, especially related to the heart and blood circulation.16789

What makes Deuterated Oxytocin unique for treating postpartum hemorrhage?

Deuterated Oxytocin is a modified version of oxytocin, which is commonly used to prevent postpartum hemorrhage. This new version may offer improved stability or effectiveness, potentially addressing some of the limitations of regular oxytocin, especially in low-resource settings.125710

What is the purpose of this trial?

Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus.After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship.The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.

Research Team

NM

Naida M Cole, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

I am having a planned or unexpected C-section that's not an emergency.
Term pregnancy (>/= 37 weeks gestation)
Intrauterine pregnancy

Exclusion Criteria

Allergy to oxytocin
Emergent cesarean delivery
Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Treatment

Participants receive a single bolus of deuterated oxytocin followed by an infusion of standard oxytocin immediately after placental delivery. Blood samples and uterine tone scores are collected intraoperatively.

1 hour
Intraoperative

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Deuterated Oxytocin
Trial Overview 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.
Participant Groups
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 placental delivery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Lucile Packard Children's Hospital

Collaborator

Trials
16
Recruited
2,800+

Findings from Research

Oxytocin is the preferred treatment for preventing postpartum hemorrhage, but its effectiveness in low-resource settings is hindered by issues such as a lack of trained healthcare professionals and poor drug quality, as highlighted in a review of 24 articles.
To effectively reduce maternal mortality from postpartum hemorrhage in these settings, it is crucial to enhance healthcare training, improve drug management practices, and address cultural barriers that limit access to necessary health services.
[The Role of Oxytocin in the Prevention of Postpartum Hemorrhage in Low-Resource Settings].Ferreira, I., Reynolds, A.[2022]
In a study of 1000 women undergoing vaginal delivery, intravenous oxytocin significantly reduced mean total blood loss during the third stage of labor compared to saline, with an average reduction of 22%.
Oxytocin also decreased the rates of severe postpartum hemorrhage (>800 mL) and low postpartum hemoglobin (<10 g/dL) by approximately 40%, suggesting it is an effective and safe treatment for managing postpartum hemorrhage.
Routine oxytocin in the third stage of labour: a placebo controlled randomised trial.Nordström, L., Fogelstam, K., Fridman, G., et al.[2019]
In a systematic review of 24 studies involving 37,383 patients, carbetocin was found to be more effective than oxytocin in reducing postpartum hemorrhage (PPH) and the need for additional uterine contractions in both cesarean and vaginal deliveries.
Carbetocin also showed a lower incidence of headaches compared to oxytocin in cesarean section patients, while both drugs had similar safety profiles regarding other side effects, suggesting that carbetocin is a promising alternative for preventing PPH.
Effectiveness and safety of carboxytocin versus oxytocin in preventing postpartum hemorrhage: A systematic review and meta-analysis.Sun, H., Xu, L., Li, Y., et al.[2022]

References

[The Role of Oxytocin in the Prevention of Postpartum Hemorrhage in Low-Resource Settings]. [2022]
Routine oxytocin in the third stage of labour: a placebo controlled randomised trial. [2019]
Effectiveness and safety of carboxytocin versus oxytocin in preventing postpartum hemorrhage: A systematic review and meta-analysis. [2022]
Intramuscular oxytocin administration before vs. after placental delivery for the prevention of postpartum hemorrhage: A randomized controlled prospective trial. [2018]
A Standardized Oxytocin Administration Protocol After Delivery to Reduce the Treatment of Postpartum Hemorrhage. [2020]
An explorative analysis of pharmacovigilance data of oxytocin and its analogue carbetocin, with a focus on haemodynamic adverse effects. [2023]
Cardiovascular effects of oxytocin and carbetocin at cesarean section. A prospective double-blind randomized study using noninvasive pulse wave analysis. [2023]
Postpartum hemorrhage: a prospective, comparative study in Angola using a new disposable device for oxytocin administration. [2018]
Side-effects of oxytocin in postpartum hemorrhage: a systematic review and meta-analysis. [2022]
The risk of postpartum hemorrhage when lowering the oxytocin dose in planned cesarean section, a pilot study. [2021]
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