Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

Phase 4

Withdrawn

• Conditions: Postpartum Hemorrhage; Uterine Atony
• Interventions: Drug: Oxytocin; Drug: Saline

• Registration Number: NCT01252342
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-02
• Study Start: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-11
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intramyometrial oxytocin	Oxytocin	-
Intramyometrial Saline	Saline	-

Primary Outcome Measures

Name	Time	Method
Uterine Tone	The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada