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

Primary Purpose

Postpartum Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Cesarean delivery, oxytocin, uterotonic, pregnancy, labour

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Oxytocin infusion rate 4 IU/h

Oxytocin infusion rate 6 IU/h

Oxytocin infusion rate 8 IU/h

Oxytocin infusion rate 10 IU/h

Oxytocin infusion rate 12 IU/h

Oxytocin infusion rate 14 IU/h

Oxytocin infusion rate 16 IU/h

Arm Description

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
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 Outcome Measures

Calculated blood loss
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
Blood product administered.
Episodes of bleeding postpartum
Number of episodes of bleeding postpartum up to 24 hours post delivery.
Intraoperative requirement for additional uterotonic medication
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
Any uterotonic medication administered while the patient is in PACU
Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.
Any uterotonic medication administered after the patient is discharged from PACU until 24 hours postpartum.
Hypotension: systolic blood pressure less than 80% of baseline
Systolic blood pressure < 80% of baseline, from drug administration until end of surgery
Hypertension: systolic blood pressure greater than 120% of baseline
Systolic blood pressure > 120% of baseline, from drug administration until end of surgery
Tachycardia: heart rate greater than 130% of baseline
Heart rate > 130% of baseline, from drug administration until end of surgery
Bradycardia: heart rate less than 70% of baseline
Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery
Presence of ventricular tachycardia: ECG
Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery
Presence of atrial fibrillation: ECG
Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery
Presence of atrial flutter: ECG
Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery
Presence of nausea: questionnaire
The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient
Presence of vomiting: questionnaire
The presence of vomiting and number of episodes, from drug administration until end of surgery
Presence of chest pain: questionnaire
Any presence of chest pain, from drug administration until end of surgery, as reported by the patient
Presence of shortness of breath: questionnaire
Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient
Presence of headache: questionnaire
Any presence of headache, from drug administration until end of surgery, as reported by the patient

Full Information

First Posted
March 11, 2022
Last Updated
August 16, 2023
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05290129
Brief Title
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
Official Title
Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Cesarean delivery, oxytocin, uterotonic, pregnancy, labour

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Biased coin up-and-down design.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin infusion rate 4 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 4 IU/h.
Arm Title
Oxytocin infusion rate 6 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 6 IU/h.
Arm Title
Oxytocin infusion rate 8 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 8 IU/h.
Arm Title
Oxytocin infusion rate 10 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 10 IU/h.
Arm Title
Oxytocin infusion rate 12 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 12 IU/h.
Arm Title
Oxytocin infusion rate 14 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 14 IU/h.
Arm Title
Oxytocin infusion rate 16 IU/h
Arm Type
Experimental
Arm Description
The maintenance infusion rate of oxytocin will be 16 IU/h.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
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 Information:
Title
Uterine tone up to discharge from the post anesthetic care unit (PACU): questionnaire
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Calculated blood loss
Description
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.
Time Frame
24 hours
Title
Need for blood transfusion
Description
Blood product administered.
Time Frame
24 hours
Title
Episodes of bleeding postpartum
Description
Number of episodes of bleeding postpartum up to 24 hours post delivery.
Time Frame
24 hours
Title
Intraoperative requirement for additional uterotonic medication
Description
A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.
Time Frame
1 hour
Title
Requirement for additional uterotonic medication in the PACU
Description
Any uterotonic medication administered while the patient is in PACU
Time Frame
2 hours
Title
Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.
Description
Any uterotonic medication administered after the patient is discharged from PACU until 24 hours postpartum.
Time Frame
24 hours
Title
Hypotension: systolic blood pressure less than 80% of baseline
Description
Systolic blood pressure < 80% of baseline, from drug administration until end of surgery
Time Frame
2 hours
Title
Hypertension: systolic blood pressure greater than 120% of baseline
Description
Systolic blood pressure > 120% of baseline, from drug administration until end of surgery
Time Frame
2 hours
Title
Tachycardia: heart rate greater than 130% of baseline
Description
Heart rate > 130% of baseline, from drug administration until end of surgery
Time Frame
2 hours
Title
Bradycardia: heart rate less than 70% of baseline
Description
Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery
Time Frame
2 hours
Title
Presence of ventricular tachycardia: ECG
Description
Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery
Time Frame
2 hours
Title
Presence of atrial fibrillation: ECG
Description
Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery
Time Frame
2 hours
Title
Presence of atrial flutter: ECG
Description
Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery
Time Frame
2 hours
Title
Presence of nausea: questionnaire
Description
The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient
Time Frame
2 hours
Title
Presence of vomiting: questionnaire
Description
The presence of vomiting and number of episodes, from drug administration until end of surgery
Time Frame
2 hours
Title
Presence of chest pain: questionnaire
Description
Any presence of chest pain, from drug administration until end of surgery, as reported by the patient
Time Frame
2 hours
Title
Presence of shortness of breath: questionnaire
Description
Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient
Time Frame
2 hours
Title
Presence of headache: questionnaire
Description
Any presence of headache, from drug administration until end of surgery, as reported by the patient
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mrinalini Balki, MD
Phone
416-586-4800
Ext
5270
Email
mrinalini.balki@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Phone
416-586-4800
Ext
5270
Email
mrinalini.balki@uhn.ca
First Name & Middle Initial & Last Name & Degree
Genevieve Lachance, MD
First Name & Middle Initial & Last Name & Degree
Jose Carvalho, MD
First Name & Middle Initial & Last Name & Degree
Jackie Thomas, MD
First Name & Middle Initial & Last Name & Degree
Kristi Downey, MSc
First Name & Middle Initial & Last Name & Degree
Atsuko Hirano, MD
First Name & Middle Initial & Last Name & Degree
Xiang Y Ye, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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