Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

NCT ID: NCT01252342

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-04-30

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.

Conditions

Postpartum Hemorrhage; Uterine Atony

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intramyometrial oxytocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.

Intramyometrial Saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.

Interventions

Oxytocin

10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.

Intervention Type: DRUG

Saline

10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica K San Vicente, MD

Role: STUDY_DIRECTOR

University of Saskatchewan, Department of Anesthesia

David C Campbell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Department of Anesthesia

Locations

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

Oxytocin

Identifier Type: -

Identifier Source: org_study_id