Status:
COMPLETED
Up-Down Oxytocin Infusion
Lead Sponsor:
IWK Health Centre
Conditions:
Uterine Atony
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00785395
Start Date
June 1 2008
End Date
August 1 2008
Last Update
November 2 2011
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8