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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01579201
• Other study ID #: LoubertHMR2012/01
• Status: Recruiting
• Phase: Phase 4
• First received: April 13, 2012
• Last updated: February 12, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Maisonneuve-Rosemont Hospital
• Contact: Christian Loubert, MD, FRCPC
• Phone: 514.252.3426
• Email: loubertch[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

Drug:
• Carbetocin
First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of carbetocin which will prevent uterine atony in 90% of subjects	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.	5 minutes	Yes
Secondary	Incidence of side effects	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.	20 minutes	No
Secondary	Vasopressors administered	The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.	20 minutes	No
Secondary	Anti nausea therapy		20 minutes	No
Secondary	Additional uterotonic medication administered		20 minutes	Yes
Secondary	Additional uterine massage		20 minutes	Yes