Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

January 9, 2012 updated by: University of Saskatchewan

Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived.

It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial).

The primary objectives of the study include:

  1. Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
  2. Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and
  3. Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.

The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy Parturients
  • Elective cesarean Delivery
  • Term (> 37 wks gestational age) as defined by ultrasound or last menstrual period
  • Singleton fetus
  • Vertex presentation
  • Age > 18
  • BMI < 40
  • Height > 5'2" and < 5"8"
  • Written informed consent

Exclusion Criteria:

  • Placenta previa
  • Multiple gestation
  • Preeclampsia
  • Gestational Diabetes or pre-existing diabetes
  • Macrosomia (estimated fetal weight prior to delivery)
  • Polyhydramnios
  • Oligohydramnios
  • Uterine fibroids
  • More than 2 previous cesarean deliveries
  • Suspected adherent placenta (acreta/increta/percreta)
  • Planned general anesthesia

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intramyometrial oxytocin
Drug: Oxytocin
10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.
Placebo Comparator: Intramyometrial Saline
Drug: Saline
10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Uterine Tone
Time Frame: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals
The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimated Blood Loss
Time Frame: Immediately Post-operatively
Immediately Post-operatively
Pre-operative to post-operative change in hematocrit
Time Frame: 24 hrs post-operative
24 hrs post-operative
Need for additional unterotonics
Time Frame: Immediately post delivery
Immediately post delivery
Need for blood pressure support
Time Frame: Intra-operative period following administration of oxytocin
Intra-operative period following administration of oxytocin

Collaborators and Investigators

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

Sponsor

University of Saskatchewan

Investigators

  • Study Director: Monica K San Vicente, MD, University of Saskatchewan, Department of Anesthesia
  • Principal Investigator: David C Campbell, MD, FRCPC, University of Saskatchewan, Department of Anesthesia

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

August 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oxytocin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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