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Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour

Primary Purpose

Blood Loss, Surgical

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

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring Cesarean Delivery, Uterine Contractility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Cesarean section secondary to failure to progress in labour
  • First stage of labour
  • Received oxytocin for at least 4 hours

Exclusion Criteria:

  • Require General Anesthesia
  • Cardiac Disease
  • Hypertension
  • Predisposition to uterine atony and postpartum hemorrhage

Sites / Locations

  • Mount Sinai Hospital

Outcomes

Primary Outcome Measures

Blood loss

Secondary Outcome Measures

Effectiveness of Uterine Contraction
Side Effects

Full Information

First Posted
May 30, 2007
Last Updated
May 30, 2007
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00481533
Brief Title
Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Official Title
Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite of marked improvements in clinical management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in the obstetric patient. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health. Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.
Detailed Description
Despite of marked improvements in management, early postpartum hemorrhage(PPH)remains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer. This complication is amongst the most challenging that a clinician will face in Obstetrics. Prevention, early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on women's health. Prophylactic oxytocin, commonly administered after fetal and placental delivery, has been shown to reduce the incidence of PPH. The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine. The effect of oxytocin is limited by the number and status of the oxytocin receptors. Increases in the dose of oxytocin will not necessarily improve uterine contraction, if receptors are not adequate in quantity and quality.This is the cause of patients exposed to oxytocin for labor augmentation, in whom oxytocin receptors are known to reduce both number and response to oxytocin. Therefore, a different uterotonic agent, involving a different mechanism of action should be used instead. Alternative drugs include ergot derivatives and prostaglandins (carboprost and misoprostol). Although protection from PPH with ergot derivatives and prostaglandin appear to be similar, prostaglandins are associated with more side effects. Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent. This study will be conducted to define whether the addition of ergonovine maleate to oxytocin, administered in a prophylactic way, reduces blood loss during Cesarean section for failure to progress in labor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
Cesarean Delivery, Uterine Contractility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methyl-Ergonovine-Oxytocin
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Primary Outcome Measure Information:
Title
Blood loss
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Effectiveness of Uterine Contraction
Time Frame
During surgery
Title
Side Effects
Time Frame
During surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cesarean section secondary to failure to progress in labour First stage of labour Received oxytocin for at least 4 hours Exclusion Criteria: Require General Anesthesia Cardiac Disease Hypertension Predisposition to uterine atony and postpartum hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD PhD
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
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18333937
Citation
Balki M, Dhumne S, Kasodekar S, Kingdom J, Windrim R, Carvalho JC. Oxytocin-ergometrine co-administration does not reduce blood loss at caesarean delivery for labour arrest. BJOG. 2008 Apr;115(5):579-84. doi: 10.1111/j.1471-0528.2007.01658.x.
Results Reference
derived

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Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour

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