Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

Postpartum Hemorrhage Clinical Trial

Official title:

Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01252342
• Other study ID #: Oxytocin
• Status: Withdrawn
• Phase: Phase 4
• First received: November 30, 2010
• Last updated: January 9, 2012
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2011
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

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

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine Tone		The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals	Yes
Secondary	Estimated Blood Loss		Immediately Post-operatively	Yes
Secondary	Pre-operative to post-operative change in hematocrit		24 hrs post-operative	Yes
Secondary	Need for additional unterotonics		Immediately post delivery	Yes
Secondary	Need for blood pressure support		Intra-operative period following administration of oxytocin	No