Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

September 22, 2020 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Comparison of Intravenous Ergonovine With Intramuscular Carboprost, Both in Combination With Oxytocin Infusion, During Cesarean Section for Failure to Progress in Labor: A Double-blinded Placebo-controlled Randomized Controlled Trial

Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the investigators study is to compare the efficacy of intravenous ergonovine and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to decrease blood loss at Cesarean section for labor arrest. Desensitization of the oxytocin receptors has been recently demonstrated in cultured human myometrial cells after continuous and prolonged exposure to oxytocin in-vitro. This could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and augmentation of labor. Therefore, addition of a different uterotonic agent, involving a different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in women undergoing CS following failure to progress in labor, who are at a greater risk for PPH.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 51 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients who give written informed consent
  • patients undergoing Cesarean section for failure to progress in labour, under regional anesthesia
  • patients should be in the first stage of labour and have received oxytocin for at least 4 hours

Exclusion Criteria:

  • patients who refuse to give written informed consent
  • patients who require general anesthesia
  • patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins
  • patients with cardiac diseases and hypertension or preeclampsia ( diastolic blood pressure > 90 mmHg, systolic blood pressure > 140 mmHg )
  • patients with asthma or any other respiratory disease
  • patients with conditions at risk of PPH such as placenta previa, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, bleeding diathesis and known infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Oxytocin only
Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Drug: Oxytocin
Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Other Names:
  • syntocinon
Active Comparator: Oxytocin + Ergot
Oxytocin 5IU IV bolus + Ergot 0.25mg IV, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Drug: Oxytocin
Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Other Names:
  • syntocinon
Drug: Ergot
Ergot 0.25mg IV
Other Names:
  • ergonovine maleate
Active Comparator: Oxytocin + Carboprost
Oxytocin 5IU IV bolus + Carboprost 0.25mg IM, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Drug: Oxytocin
Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Other Names:
  • syntocinon
Drug: Carboprost
Carboprost 0.25mg IM
Other Names:
  • Hemabate®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Need for additional uterotonics intraoperatively
Time Frame: 1 hour
Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of uterine contraction
Time Frame: 10 min
Adequate/inadequate uterine tone at 3,5 & 10 min
10 min
Need for blood transfusion
Time Frame: 24 hours
Any blood products administered
24 hours
Vital signs
Time Frame: 2 hours
In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities
2 hours
Side effects
Time Frame: 24 hours
The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded.
24 hours
Estimated blood loss
Time Frame: 48 hours
calculated blood loss = EBV (Pre-op Htc-Post-op Htc) EBV (estimated blood volume, mL)=patient's weight in kg x 85
48 hours
Need for additional uterotonics or interventions post-operatively
Time Frame: 24 hours
Need for additional uterotonics or interventions post-operatively up to 24 hours post-partum
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-05

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