ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery

Phase 4

• Conditions: Postpartum Hemorrhage; Uterine Atony
• Interventions: Drug: Carbetocin

• Registration Number: NCT01579201
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

The purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.

Detailed Description

Postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. Carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. The Society of Obstetricians and Gynecologists of Canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. However, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. The use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing.

In this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. The effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ED90) will be determined using a biased coin design up-down sequential allocation method. The determination of the carbetocin ED90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-15
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Healthy pregnant women (ASA I or II)
• Elective cesarean delivery
• Spinal anesthesia
• Term gestation (37 weeks and above)

Exclusion Criteria

• Multiple gestation
• Known coagulopathy
• Active labour
• Uterine fibroids
• Body mass index > 45
• Emergency cesarean section
• General anesthesia
• Any contraindication to neuraxial anesthesia
• Cardiopathies
• Known allergies to carbetocin
• Patient refusal
• Placenta previa/Placenta accreta
• Hypertensive disease/Preeclampsia/Eclampsia
• Polyhydramnios
• Previous history of uterine atony or postpartum hemorrhage
• Renal or liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carbetocin	Carbetocin	-

Primary Outcome Measures

Name	Time	Method
Dose of carbetocin which will prevent uterine atony in 90% of subjects	5 minutes	The uterine tone will be assessed by the obstetrician by palpation 5 minutes after injection. The uterine tone will be judged either as satisfactory or unsatisfactory.

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects	20 minutes	Any of these side effects will be noted in the first 20 minutes following injection of carbetocin: hypotension, tachycardia, nausea, vomiting, flushing, headache, feeling of warmth, tremor, metallic taste, abdominal pain, back pain, chest pain and others.
Vasopressors administered	20 minutes	The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.
Anti nausea therapy	20 minutes
Additional uterotonic medication administered	20 minutes
Additional uterine massage	20 minutes

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada