Carbetocin at Elective Cesarean Delivery Part 2

Postpartum Hemorrhage Clinical Trial

Official title:

Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428817
• Other study ID #: 11-02
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: March 23, 2012
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.

Description:

The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery.

Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied.

The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All patients planned for elective cesarean delivery under spinal anesthesia.

• All patients who give written informed consent to participate in this study.

Exclusion Criteria:

• All patients who refuse to give written informed consent.

• All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.

• All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.

• All patients with hepatic, renal, and vascular disease,

• All patients requiring general anesthesia prior to the administration of the study drug.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Carbetocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
• Carbetocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
• Carbetocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
• Carbetocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
• Carbetocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine tone	The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).	2 minutes	Yes
Secondary	Uterine tone	Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.	2 hours	Yes
Secondary	Blood loss	Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.	48 hours	Yes
Secondary	Side effects	Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others	2 hours	Yes