Carbetocin at Elective Cesarean Delivery Part 2

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01428817

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Carbetocin Drug: Carbetocin Drug: Carbetocin Drug: Carbetocin Drug: Carbetocin	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carbetocin 20mcg	Drug: Carbetocin 20mcg carbetocin, IV, over 1 minute following delivery of the fetal head. Other Names: Duratocin
Active Comparator: Carbetocin 40mcg	Drug: Carbetocin 40mcg carbetocin, IV, over 1 minute following delivery of the fetal head. Other Names: Duratocin
Active Comparator: Carbetocin 60mcg	Drug: Carbetocin 60mcg carbetocin, IV, over 1 minute following delivery of the fetal head. Other Names: Duratocin
Active Comparator: Carbetocin 80mcg	Drug: Carbetocin 80mcg carbetocin, IV, over 1 minute following delivery of the fetal head. Other Names: Duratocin
Active Comparator: Carbetocin 100mcg	Drug: Carbetocin 100mcg carbetocin, IV, over 1 minute following delivery of the fetal head. Other Names: Duratocin

Outcome Measures

Primary Outcome Measures

Uterine tone [2 minutes]
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).

Secondary Outcome Measures

Uterine tone [2 hours]
Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.
Blood loss [48 hours]
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.
Side effects [2 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.