Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
NCT05290129

Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study

Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-06

40

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. 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. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU/min (44 IU/h), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.

CONDITIONS

Official Title

Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia
  • At least 3 hours of oxytocin exposure during labour prior to cesarean delivery
Not Eligible

You will not qualify if you...

  • Patients who refuse to give written informed consent
  • Allergy or hypersensitivity to oxytocin
  • History of hypertension and/or severe cardiac disease
  • Contraindications for neuraxial anesthesia
  • Patients converted to general anesthesia during surgery
  • Placenta previa
  • Multiple gestation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G1X5

Actively Recruiting

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Research Team

M

Mrinalini Balki, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

10

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