Postpartum Hemorrhage, Uterine Atony
Conditions
Keywords
Oxytocin, Intramyometrial
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.
Interventions
DRUGOxytocin
10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.
DRUGSaline
10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 \< 58 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine Tone | The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals |
Secondary
| Measure | Time frame |
|---|---|
| Estimated Blood Loss | Immediately Post-operatively |
| Pre-operative to post-operative change in hematocrit | 24 hrs post-operative |
| Need for additional unterotonics | Immediately post delivery |
| Need for blood pressure support | Intra-operative period following administration of oxytocin |
Countries
Canada
Outcome results
None listed