Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
|ClinicalTrials.gov 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Recruitment Status : Withdrawn (Proposed doses were too large, bolus oxytocin may cause cases of arrythmias, and some even advocate slowing down the infusion rates that are currently used.)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
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:
- Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
- 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
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Experimental: Intramyometrial 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||
10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.
- Uterine Tone [ Time Frame: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals ]
- Estimated Blood Loss [ Time Frame: Immediately Post-operatively ]
- Pre-operative to post-operative change in hematocrit [ Time Frame: 24 hrs post-operative ]
- Need for additional unterotonics [ Time Frame: Immediately post delivery ]
- Need for blood pressure support [ Time Frame: Intra-operative period following administration of oxytocin ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252342
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|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|