Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries

Recruiting in Palo Alto (17 mi)

Overseen by Mrinalini Balki, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. If the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. The dose for the next patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 IU/h).

Eligibility Criteria

Inclusion Criteria

Elective uncomplicated cesarean delivery under neuraxial anesthesia

>18 year-old with ASA status II or III, with a singleton gestation and a gestational age between 37 to 42 weeks Informed consent to participate in this study

Treatment Details

Interventions

• Oxytocin (Hormone Therapy)

Participant Groups

Group I: Oxytocin infusion rate 8 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 8 IU/h.

Group II: Oxytocin infusion rate 6 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 6 IU/h.

Group III: Oxytocin infusion rate 4 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 4 IU/h.

Group IV: Oxytocin infusion rate 2 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 2 IU/h.

Group V: Oxytocin infusion rate 16 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 16 IU/h.

Group VI: Oxytocin infusion rate 14 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 14 IU/h.

Group VII: Oxytocin infusion rate 12 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 12 IU/h.

Group VIII: Oxytocin infusion rate 10 IU/h Experimental Treatment 1 Intervention

The maintenance infusion rate of oxytocin will be 10 IU/h.

Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

🇪🇺 Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

🇨🇦 Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

🇦🇺 Approved in Australia as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Control of postpartum bleeding

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mount Sinai Hospital Toronto, Canada

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital Lead Sponsor

References