CompletedNot Applicable

Carbetocin at Cesarean Delivery for Labor Arrest

Canada40 participantsStarted 2012-11

Plain-language summary

In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients who have given written informed consent to participate in this study. * All patients planned for uncomplicated low transverse cesarean delivery secondary to labor arrest, under epidural anesthesia. * ≥37 week pregnancy * Singleton pregnancy * Patients who have received oxytocin for at least 4 hours for labor augmentation * ASA 1 or 2 Exclusion Criteria: * Refusal or inability to obtain informed consent. * All patients who claim allergy or hypersensitivity to oxytocin and carbetocin. * Previous history of uterine atony or PPH * Risk factors for PPH such as pre-eclampsia, polyhydramnios, uterine fibroids, bleeding diathesis and chorioamnionitis etc. * Abnormal placental implantation (known or suspected) * \> 3 cesarean sections in the past * Previous classic uterine incision * Macrosomia - Estimated fetal weight \> 4500g * Hemoglobin \< 100g/L * Cesarean section under general anesthesia * ASA 3 and 4 or patients with hepatic, renal, cardiac (eg. Coronary artery disease) and vascular disease * Genital development problems (eg. Abnormal uterus, cervix, vagina, etc.) * Uncontrolled hypotension or hypertension * Uncontrolled diabetes * Abnormal heart rhythms and bradycardia * Drug abusers

What they're measuring

need for additional uterotonics

Timeframe: 30 minutes

Trial details

NCT IDNCT01725243

SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03