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Up-Down Oxytocin Infusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00785395
First received: October 27, 2008
Last updated: November 1, 2011
Last verified: November 2008

October 27, 2008
November 1, 2011
June 2008
August 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00785395 on ClinicalTrials.gov Archive Site
Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Up-Down Oxytocin Infusion
Up-down Determination of the ED90 of Oxytocin Infusions for the Prevention of Postpartum Uterine Atony in Parturients Undergoing Cesarean Delivery

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Uterine Atony
Drug: Oxytocin infusion
Up-down dosing determination
Experimental: A
Intervention: Drug: Oxytocin infusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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)
  2. American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
  3. Age ≥ 18 years
  4. Term gestational age (≥ 37 weeks)
  5. English-speaking

Exclusion Criteria:

  1. 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)
  2. Laboring women
  3. Urgent or emergency cesarean delivery
  4. 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
  5. Severe maternal cardiac disease
  6. Subjects predisposed to uterine atony and postpartum hemorrhage (i.e. placenta previa, multiple gestation, macrosomia, polyhydramnios, uterine abnormalities, or bleeding diathesis, > 2 previous CD)
  7. Fetal anomalies /Intrauterine Fetal Demise
  8. Failed spinal anesthesia
  9. Patient enrollment in another study involving a study medication within 30 days of CD
  10. Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00785395
IWK-4329-2008
Yes
Ronald George, IWK Health Centre
IWK Health Centre
Not Provided
Principal Investigator: Ronald B George, MD FRCPC IWK
IWK Health Centre
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP