Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Fai… (NCT01869556) | Clinical Trial Compass
CompletedNot Applicable
Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress
Canada105 participantsStarted 2013-06-04
Plain-language summary
Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.
Who can participate
Age range
14 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:
* patients who give written informed consent
* patients undergoing Cesarean section for failure to progress in labour, under regional anesthesia
* patients should be in the first stage of labour and have received oxytocin for at least 4 hours
Exclusion Criteria:
* patients who refuse to give written informed consent
* patients who require general anesthesia
* patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins
* patients with cardiac diseases and hypertension or preeclampsia ( diastolic blood pressure \> 90 mmHg, systolic blood pressure \> 140 mmHg )
* patients with asthma or any other respiratory disease
* patients with conditions at risk of PPH such as placenta previa, multiple gestation, preeclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, bleeding diathesis and known infection.
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 intraoperatively
Timeframe: 1 hour
Trial details
NCT IDNCT01869556
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital