search
Back to results

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy

Primary Purpose

Postpartum Hemorrhage, Twin

Status
Completed
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 pregnancy, twin, postpartum hemorrhage, oxytocin, Cesarean delivery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Twin pregnancy
  • Elective cesarean delivery under regional anesthesia
  • Gestational age ≥36 weeks
  • No known additional risk factors for postpartum hemorrhage
  • Written informed consent to participate in this study

Exclusion Criteria:

  • Refusal to give written informed consent
  • Allergy or hypersensitivity to oxytocin
  • Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40
  • Hepatic, renal, and vascular disease
  • Use of general anesthesia prior to the administration of the study drug

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oxytocin 0.5IU

Oxytocin 1IU

Oxytocin 2IU

Oxytocin 3IU

Oxytocin 4IU

Oxytocin 5IU

Arm Description

Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Patient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Outcomes

Primary Outcome Measures

Uterine tone 2 minutes: questionnaire
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).

Secondary Outcome Measures

Need for uterine massage: questionnaire
The obstetricians will be asked if there was any need for uterine massage beyond the initial 3 minute evaluation period following 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.
Calculated estimate of blood loss
Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean delivery, according to the following formula: Calculated blood loss = EBV ((Pre-op Htc-Post-op Htc)/pre-op Htc). EBV (estimated blood volume) in ml: patient's weight in kg x 85
Intravenous fluid administered during surgery
The total volume (ml) of fluid administered from entering the operating room to skin closure.
Hypotension: systolic blood pressure less than 80% of baseline
Systolic blood pressure < 80% 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
Presence of flushing: questionnaire
Any presence of flushing, from drug administration until end of surgery

Full Information

First Posted
July 17, 2019
Last Updated
January 27, 2022
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04025658
Brief Title
Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy
Official Title
Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)

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
Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth and these are effective at reducing the incidence of PPH. Large doses of this drug are associated with adverse effects like lower blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage. The investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately.
Detailed Description
Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. Furthermore, recent evidence has shown that the rate of PPH secondary to uterine atony is increasing. Multiple pregnancy is a well-recognized risk factor for PPH. Compared with singleton pregnancy, women with a multiple pregnancy have an increased risk of PPH, severe PPH, transfusion, uterine atony, hysterectomy, prolonged hospital stay and death. This is true in both high- and low-income countries. Uterine atony as a cause of PPH is more likely in multiple pregnancy compared with singleton pregnancy. Prophylactic uterotonic drugs administered after the delivery have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly administered uterotonic drug used to prevent PPH in North America but is associated with adverse effects such as hypotension, nausea, vomiting, dysrhythmias, ST segment abnormalities, and severe water intoxication that may lead to pulmonary edema and convulsions. Previous dose finding studies have excluded women with twin pregnancies. Therefore, the investigators wish to perform a double blinded dose finding study using the biased coin flip up-and-down sequential allocation technique to determine the ED 90 of oxytocin at cesarean section in those women with a twin pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Twin
Keywords
pregnancy, twin, postpartum hemorrhage, oxytocin, Cesarean delivery

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
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin 0.5IU
Arm Type
Active Comparator
Arm Description
Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Arm Title
Oxytocin 1IU
Arm Type
Active Comparator
Arm Description
Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Arm Title
Oxytocin 2IU
Arm Type
Active Comparator
Arm Description
Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Arm Title
Oxytocin 3IU
Arm Type
Active Comparator
Arm Description
Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Arm Title
Oxytocin 4IU
Arm Type
Active Comparator
Arm Description
Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Arm Title
Oxytocin 5IU
Arm Type
Active Comparator
Arm Description
Patient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
pitocin
Intervention Description
Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
Primary Outcome Measure Information:
Title
Uterine tone 2 minutes: questionnaire
Description
Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Need for uterine massage: questionnaire
Description
The obstetricians will be asked if there was any need for uterine massage beyond the initial 3 minute evaluation period following delivery.
Time Frame
20 minutes
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
2 hours
Title
Calculated estimate of blood loss
Description
Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean delivery, according to the following formula: Calculated blood loss = 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
Intravenous fluid administered during surgery
Description
The total volume (ml) of fluid administered from entering the operating room to skin closure.
Time Frame
2 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
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
Title
Presence of flushing: questionnaire
Description
Any presence of flushing, from drug administration until end of surgery
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: Twin pregnancy Elective cesarean delivery under regional anesthesia Gestational age ≥36 weeks No known additional risk factors for postpartum hemorrhage Written informed consent to participate in this study Exclusion Criteria: Refusal to give written informed consent Allergy or hypersensitivity to oxytocin Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40 Hepatic, renal, and vascular disease Use of general anesthesia prior to the administration of the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carvalho, 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

12. IPD Sharing Statement

Learn more about this trial

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy

We'll reach out to this number within 24 hrs