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

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05290129

Collaborator

(none)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Oxytocin	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Biased coin up-and-down design.Biased coin up-and-down design.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 17, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxytocin infusion rate 4 IU/h The maintenance infusion rate of oxytocin will be 4 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin
Experimental: Oxytocin infusion rate 6 IU/h The maintenance infusion rate of oxytocin will be 6 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin
Experimental: Oxytocin infusion rate 8 IU/h The maintenance infusion rate of oxytocin will be 8 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin
Experimental: Oxytocin infusion rate 10 IU/h The maintenance infusion rate of oxytocin will be 10 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin
Experimental: Oxytocin infusion rate 12 IU/h The maintenance infusion rate of oxytocin will be 12 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin
Experimental: Oxytocin infusion rate 14 IU/h The maintenance infusion rate of oxytocin will be 14 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin
Experimental: Oxytocin infusion rate 16 IU/h The maintenance infusion rate of oxytocin will be 16 IU/h.	Drug: Oxytocin Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h. Other Names: Pitocin

Outcome Measures

Primary Outcome Measures

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

Calculated blood loss [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 [24 hours]
Blood product administered.
Episodes of bleeding postpartum [24 hours]
Number of episodes of bleeding postpartum up to 24 hours post delivery.
Intraoperative requirement for additional uterotonic medication [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 [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. [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 [2 hours]
Systolic blood pressure < 80% of baseline, from drug administration until end of surgery
Hypertension: systolic blood pressure greater than 120% of baseline [2 hours]
Systolic blood pressure > 120% of baseline, from drug administration until end of surgery
Tachycardia: heart rate greater than 130% of baseline [2 hours]
Heart rate > 130% of baseline, from drug administration until end of surgery
Bradycardia: heart rate less than 70% of baseline [2 hours]
Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery
Presence of ventricular tachycardia: ECG [2 hours]
Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery
Presence of atrial fibrillation: ECG [2 hours]
Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery
Presence of atrial flutter: ECG [2 hours]
Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery
Presence of nausea: questionnaire [2 hours]
The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient
Presence of vomiting: questionnaire [2 hours]
The presence of vomiting and number of episodes, from drug administration until end of surgery
Presence of chest pain: questionnaire [2 hours]
Any presence of chest pain, from drug administration until end of surgery, as reported by the patient
Presence of shortness of breath: questionnaire [2 hours]
Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient
Presence of headache: questionnaire [2 hours]
Any presence of headache, from drug administration until end of surgery, as reported by the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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)