Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

NCT01252342 | Withdrawn Phase 4

• 1 other identifier: Oxytocin
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
2. 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. 3.Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.

Conditions

Postpartum Hemorrhage; Uterine Atony

Keywords

Oxytocin; Intramyometrial

Outcome Measures

Primary Outcomes (1)

• Uterine Tone

  The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals

Secondary Outcomes (4)

• 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

Study Arms (2)

Intramyometrial oxytocin

EXPERIMENTAL

Drug: Oxytocin

Intramyometrial Saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

Oxytocin DRUG

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

Intramyometrial oxytocin

Saline DRUG

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

Intramyometrial Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Monica K San Vicente, MD

  University of Saskatchewan, Department of Anesthesia

  STUDY DIRECTOR

• David C Campbell, MD, FRCPC

  University of Saskatchewan, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 11, 2012

Record last verified: 2011-10

Locations

CA (1)