NCT00785395

Brief Summary

This study is designed to determine the minimum effective dose (ED90) of infusions of oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for additional uterotonics, in low risk parturients presenting for an elective CD. The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2008

Enrollment Period

2 months

First QC Date

October 27, 2008

Last Update Submit

November 1, 2011

Conditions

Uterine Atony

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose.

    3 minutes

Secondary Outcomes (1)

  • Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.

    2 days

Study Arms (1)

A

EXPERIMENTAL
Drug: Oxytocin infusion

Interventions

Oxytocin infusionDRUG

Up-down dosing determination

A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
  • American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
  • Age ≥ 18 years
  • Term gestational age (≥ 37 weeks)
  • English-speaking

You may not qualify if:

  • Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
  • Laboring women
  • Urgent or emergency cesarean delivery
  • Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
  • Severe maternal cardiac disease
  • Subjects predisposed to uterine atony and postpartum hemorrhage (i.e. placenta previa, multiple gestation, macrosomia, polyhydramnios, uterine abnormalities, or bleeding diathesis, \> 2 previous CD)
  • Fetal anomalies /Intrauterine Fetal Demise
  • Failed spinal anesthesia
  • Patient enrollment in another study involving a study medication within 30 days of CD
  • Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

  • George RB, McKeen D, Chaplin AC, McLeod L. Up-down determination of the ED(90) of oxytocin infusions for the prevention of postpartum uterine atony in parturients undergoing Cesarean delivery. Can J Anaesth. 2010 Jun;57(6):578-82. doi: 10.1007/s12630-010-9297-1. Epub 2010 Mar 18.

    PMID: 20238255DERIVED

MeSH Terms

Conditions

Uterine Inertia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ronald B George, MD FRCPC

    IWK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

First Submitted

October 27, 2008

First Posted

November 5, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 2, 2011

Record last verified: 2008-11

Locations

CA(1)