Carbetocin at Cesarean Delivery for Labor Arrest (NCT01725243) | Clinical Trial Compass
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 range
18 Years – 55 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
need for additional uterotonics
Timeframe: 30 minutes
Trial details
NCT IDNCT01725243
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital