Recruiting

Oxytocin

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT05290129

Conditions

Postpartum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Oxytocin

Study Details

Brief summary:

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

Postpartum Hemorrhage

Study ID

NCT05290129

Start date

Aug 17, 2022

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

• All patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia (at least 3 hours of prior exposure to oxytocin during labour)

Exclusion Criteria:

  • All patients who refuse to give written informed consent
  • All patients who declare allergy or hypersensitivity to oxytocin
  • A history of hypertension and/or severe cardiac disease(s)
  • All patients who have contraindications for neuraxial anesthesia
  • All patients who will be converted to general anesthesia intraoperatively
  • All patients with placenta previa and multiple gestation

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oxytocin infusion rate 4 IU/h

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

experimental: Oxytocin infusion rate 6 IU/h

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

experimental: Oxytocin infusion rate 10 IU/h

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

experimental: Oxytocin infusion rate 14 IU/h

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

experimental: Oxytocin infusion rate 18 IU/h

The maintenance infusion rate of oxytocin will be 18 IU/h.

experimental: Oxytocin infusion rate 22 IU/h

The maintenance infusion rate of oxytocin will be 22 IU/h.

experimental: Oxytocin infusion rate 26 IU/h

The maintenance infusion rate of oxytocin will be 26 IU/h.

experimental: Oxytocin infusion rate 30 IU/h

The maintenance infusion rate of oxytocin will be 30 IU/h.

experimental: Oxytocin infusion rate 34 IU/h

The maintenance infusion rate of oxytocin will be 34 IU/h.

experimental: Oxytocin infusion rate 36 IU/h

The maintenance infusion rate of oxytocin will be 36 IU/h.

Interventions

Oxytocin

Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h.

Primary outcome measure

  • Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Apr 6, 2026

Last verified

Feb, 2026

Keywords

  • Cesarean delivery
  • oxytocin
  • uterotonic
  • pregnancy
  • labour

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-04-06.