ED90 Determination of Carbetocin for the Prevention of Uterine Atony in Women Undergoing an Elective Cesarean Delivery
ED90 Determination of Carbetocin for the Prevention of Postpartum Uterine Atony in Women Undergoing an Elective Cesarean Delivery
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Quebec
-
Montreal, Quebec, Kanada, H1T 2M4
- Rekrytering
- Maisonneuve-Rosemont Hospital
-
Kontakt:
- Christian Loubert, MD, FRCPC
- Telefonnummer: 514.252.3426
- E-post: loubertch@yahoo.fr
-
Kontakt:
- Louis-Philippe Fortier, MD, FRCPC
- Telefonnummer: 514.252.3426
- E-post: lpfortier@mac.com
-
Huvudutredare:
- Christian Loubert, MD, FRCPC
-
Underutredare:
- Louis-Philippe Fortier, MD, FRCPC
-
Underutredare:
- Patrick Coursol-Provost, MD
-
Underutredare:
- Pierre Drolet, MD, FRCPC
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dose of carbetocin which will prevent uterine atony in 90% of subjects
Tidsram: 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.
|
5 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of side effects
Tidsram: 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.
|
20 minutes
|
|
Vasopressors administered
Tidsram: 20 minutes
|
The total dose of vasopressors administered in the first 20 minutes following the administration of carbetocin will be noted.
|
20 minutes
|
|
Anti nausea therapy
Tidsram: 20 minutes
|
20 minutes
|
|
|
Additional uterotonic medication administered
Tidsram: 20 minutes
|
20 minutes
|
|
|
Additional uterine massage
Tidsram: 20 minutes
|
20 minutes
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LoubertHMR2012/01
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