Up-Down Oxytocin Infusion

Uterine Atony Clinical Trial

Official title:

Up-down Determination of the ED90 of Oxytocin Infusions for the Prevention of Postpartum Uterine Atony in Parturients Undergoing Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785395
• Other study ID #: IWK-4329-2008
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: November 1, 2011
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: November 2008
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Uterine Atony
• Uterine Inertia

Intervention

Drug:
• Oxytocin infusion
Up-down dosing determination

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.		2 days	No