Clinical trial NCT01252342: Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
Official title: Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Uterine Atony
Keywords: Oxytocin
Intramyometrial
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Uterine Tone
timeFrame: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals
Secondary outcomes:
measure: Estimated Blood Loss
timeFrame: Immediately Post-operatively
measure: Pre-operative to post-operative change in hematocrit
timeFrame: 24 hrs post-operative
measure: Need for additional unterotonics
timeFrame: Immediately post delivery
measure: Need for blood pressure support
timeFrame: Intra-operative period following administration of oxytocin
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Department of Anesthesia
name: Monica K San Vicente, MD
role: STUDY_DIRECTOR
affiliation: University of Saskatchewan, Department of Anesthesia
name: David C Campbell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: