DRUG
Oxytocin
Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h.
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
Status
Recruiting
Phase
Not applicable
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 22, 2022
Study start
Aug 17, 2022
Primary completion
Dec 2026
Study completion
Dec 2026
Results posted
Not reported
Registry updated
Apr 6, 2026
Outcomes
What the study measures.
Primary outcomes
Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
Time frame · 2 hours
Uterine tone will be evaluated as satisfactory or unsatisfactory by the obstetrician throughout the surgery, starting at 5 minutes after the oxytocin infusion. It will also be measured at 10 minutes following the oxytocin infusion and every 10 minutes following that for the duration of the surgery. Unsatisfactory uterine tone at any time until discharge from the PACU will be considered a failure of the maintenance infusion.
Secondary outcomes
Calculated blood loss
Time frame · 24 hours
Estimated blood loss will be calculated using the difference in hematocrit values prior to surgery and 24 hours post surgery, using the following formula: Calculated blood loss (mL) = EBV ((Pre-op Htc-Post-op Htc)/pre-op Htc) EBV (estimated blood volume) in ml: patient's weight in kg x 85.
Need for blood transfusion
Time frame · 24 hours
Blood product administered.
Episodes of bleeding postpartum
Time frame · 24 hours
Number of episodes of bleeding postpartum up to 24 hours post delivery.
Intraoperative requirement for additional uterotonic medication
Time frame · 1 hour
A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.
Requirement for additional uterotonic medication in the PACU
Time frame · 2 hours
Any uterotonic medication administered while the patient is in PACU
Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.
Time frame · 24 hours
Any uterotonic medication administered after the patient is discharged from PACU until 24 hours postpartum.
Hypotension: systolic blood pressure less than 80% of baseline
Time frame · 2 hours
Systolic blood pressure \< 80% of baseline, from drug administration until end of surgery
Hypertension: systolic blood pressure greater than 120% of baseline
Time frame · 2 hours
Systolic blood pressure \> 120% of baseline, from drug administration until end of surgery
Tachycardia: heart rate greater than 130% of baseline
Time frame · 2 hours
Heart rate \> 130% of baseline, from drug administration until end of surgery
Bradycardia: heart rate less than 70% of baseline
Time frame · 2 hours
Heart rate \< 70% of baseline or a heart rate \< 50bpm, from drug administration until end of surgery
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
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 locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Mount Sinai Hospital
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Oxytocin.
NCT IDStudyPhase / statusEnrollmentUpdated
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Phase 2
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Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
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Recruiting
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Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction
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Not applicable
Recruiting
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Put the record in context.
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