Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01252342
First received: November 30, 2010
Last updated: January 9, 2012
Last verified: October 2011
  Purpose

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 Intervention Phase
Postpartum Hemorrhage
Uterine Atony
Drug: Oxytocin
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

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

Secondary Outcome Measures:
  • Estimated Blood Loss [ Time Frame: Immediately Post-operatively ] [ Designated as safety issue: Yes ]
  • Pre-operative to post-operative change in hematocrit [ Time Frame: 24 hrs post-operative ] [ Designated as safety issue: Yes ]
  • Need for additional unterotonics [ Time Frame: Immediately post delivery ] [ Designated as safety issue: Yes ]
  • Need for blood pressure support [ Time Frame: Intra-operative period following administration of oxytocin ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252342

Locations
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01252342     History of Changes
Other Study ID Numbers: Oxytocin
Study First Received: November 30, 2010
Last Updated: January 9, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Oxytocin
Intramyometrial

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Dystocia
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014