Does Intramyometrial Oxytocin Improve Outcome in Elective... | NCT01252342

Studies
Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

NCT01252342

Sponsor

University of Saskatchewan

Status

Withdrawn

Last Update Posted

Jan 11, 2012Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Postpartum Hemorrhage
Uterine Atony

Interventions

Oxytocin
Saline

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Proposed doses were too large, bolus oxytocin may cause cases of arrythmias, and some even advocate slowing down the infusion rates that are currently used.

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Apr 2012Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Nov 30, 2010

First Submission Date that Met QC Criteria

Nov 30, 2010

First Posted Date

Dec 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2012

Last Update Posted Date

Jan 11, 2012Estimated

Description Module

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:

Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
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
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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intramyometrial oxytocin	Experimental		Drug: Oxytocin
Intramyometrial Saline	Placebo Comparator		Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Estimated Blood Loss		Immediately Post-operatively
Pre-operative to post-operative change in hematocrit		24 hrs post-operative
Need for additional unterotonics

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal University Hospital		Saskatoon	Saskatchewan	S7N 0W8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage
D014593	Uterine Inertia

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided