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Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252342
Recruitment Status : Withdrawn (Proposed doses were too large, bolus oxytocin may cause cases of arrythmias, and some even advocate slowing down the infusion rates that are currently used.)
First Posted : December 2, 2010
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
University of Saskatchewan

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Uterine Atony Drug: Oxytocin Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
Study Start Date : August 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Oxytocin

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.

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

Secondary Outcome Measures :
  1. Estimated Blood Loss [ Time Frame: Immediately Post-operatively ]
  2. Pre-operative to post-operative change in hematocrit [ Time Frame: 24 hrs post-operative ]
  3. Need for additional unterotonics [ Time Frame: Immediately post delivery ]
  4. Need for blood pressure support [ Time Frame: Intra-operative period following administration of oxytocin ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252342

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Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
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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

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Responsible Party: University of Saskatchewan Identifier: NCT01252342    
Other Study ID Numbers: Oxytocin
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: October 2011
Keywords provided by University of Saskatchewan:
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Reproductive Control Agents
Physiological Effects of Drugs